1 Professor Ann-Lii Cheng has contributed significantly to the basic knowledge and clinical application of molecular targeted therapy and immunotherapy in hepatocellular carcinoma (HCC). Living in the part of the world plagued by HCC, Prof. Cheng has devoted his career in substantiating a solution. Since year 2004 he has been heavily involved in the development of sorafenib and lenvatinib, two pivotal drugs in the first-line treatment of HCC, and recently the discovery of a new regimen, atezolizumab plus bevacizumab, which is considered an epoch-making breakthrough in this field, and remains standard-of-care of advanced HCC until now. He severed as global coordinating PI of all of these pivotal international studies, and was first or corresponding authors of the final publications in Lancet Oncology, Lancet, and NEJM, respectively. He also served similar roles in more than 30 other global studies of HCC. His research team at National Taiwan University has been recognized as one of the most conspicuous translational research groups in exploring the frontier of HCC treatment. 2 2012：Member of Governing Board, International Liver Cancer Association (ILCA) 3 2017：President, APPLE (Asia Pacific Primary Liver Cancer Expert Meeting) Society 4 2020：Blue Faery Award for Excellence in Liver Cancer Research, U.S.A. 5 2020, 2023：National Taiwan University Distinguished Chair Professor(台灣大學特聘講座教授) 6 2021~2024：Clarivate Analytics Highly Cited Researchers (科睿唯安評比全球高引用學者)

Clinical Studies： 1.Phase II trial of medroxyprogesterone acetate plus weekly 24-hour infusion of high-dose 5-FU/leucovorin in advanced gastric cancer (Principal investigator, NHRI CCRW, 1995/08) 2.Phase II trial of medroxyprogesterone acetate plus weekly 24-hour infusion of high-dose 5-FU/leucovorin in metastatic gastric cancer with prior chemotherapy (Principal investigator, NHRI CCRW,1995/08) 3.Eradication of Helicobacter pylori in the management of stage IE and IIE-1 primary low-grade B-cell lymphoma of mucosa- associated lymphoid tissue type of the stomach (Principal investigator, TCOG, 1996/03 ~1999/10) 4.Phase II trial of 24-hour infusion of 5-FU/LV following gemcitabine in advanced pancreatic adenocarcinoma. (Principal investigator, CCRC, 1997/6 ~2000/9) 5.Phase II trial of liposomal-adriamycin (Doxil) in inoperable hepatocellular carcinoma (Principal investigator, CCRC, 1997/06 ~). 6.Phase III randomized trial comparing adjuvant recombinant interferon-a versus conservative treatment in postoperative hepatocellular carcinoma (Principal investigator , TCOG, 1997/10 ~ 2003/04) 7.Dose finding study of weekly docetaxel followed by 24-hour infusion of high-dose 5-FU/leucovorin and cisplatin in the management of advanced gastric cancer (Principal investigator, NHRI CCRW, 1998/08 ~ 1999/12) 8.Multi-centre trial of 5-FU/leucovorin/oxaliplatin in the treatment of 5-FU/ leucovorin resistant colorectal cancer (Co- investigator, 1999/09 ~2000/05) 9.Phase II study of biweekly Oxaliplatin plus 46-hour infusion of fluorouracil and leucovorin as second-line therapy in HDFL- failed advanced gastric cancer. (Principal investigator, NHRI CCRC, 1999/04 ~ 2000/10) 10.Phase I and pharmacokinetic studies of oral thalidomide in advanced hepatocellular carcinoma (Principal investigator, NHRI CCRC, 2000/01 ~ 2000/08) 11.A Phase II study of oxaliplatin and weekly 24-hour infusion of high-dose 5-fluorouracil and leucovorin (HDFL) in the first-line treatment of inoperable, locally advanced or recurrent/metastatic gastric cancer (Co-investigator, 2000/10 ~2002/08) 12.Phase I/II study of biweekly gemcitabine, oxaliplatin and 46-hour infusion of fluorouracil and leucovorin in advanced pancreatic cancer. (Principal investigator, NHRI CCRC, 2002/01 ~ 2005/06) 13.Pilot study of biweekly oxaliplatin plus 46-hour infusion of fluorouracil and leucovorin in metastatic/unresectable biliary tree cancer. (Principal investigator, NHRI CCRC, 2001/05 ~ 2004/06) 14.Placebo-controlled, randomized phase III trial of oral thalidomide in advanced HCC patients with poor liver reserve. (Principal investigator, TCOG, 2003/02 ~ ongoing) 15.Phase II study of weekly paclitaxel plus oral UFT/leucovorin in advanced gastric cancer. (Co-PI, Multicentre study, 2003/ ~ 2004/12) 16.Randomized phase II study of pegylated-arginine deiminase (ADI-PEG 20) in advanced hepatocellular carcinoma. (PI, Industry sponsored, multicentre study, 2004/02 ~ 2004/10) 17.Phase II study of neoadjuvant GOFL followed by gemcitabine-based concurrent chemoradiotherapy in locally advanced pancreatic cancer. (PI, PI-initiated, TCOG study, 2004/06 ~ 2008/07) 18.Phase II study of biweekly oxaliplatin plus 46-hour infusion of fluorouracil and leucovorin in metastatic/unresectable biliary tree cancer. (PI, PI-initiated, multicentre study, 2004/06 ~ ) 19.Phase I study of ALIMTA plus cisplatin in advanced gastric cancer (Co-PI, Industry-sponsored, multicentre study, 2004/ ~ ) 20.Phase I and pharmacokinetic study of liposomal-irinotecan in refractory solid tumors. (Co-PI, Industry-sponsored, multicentre study, 2005/ 02 ~ 2006/04) 21.Phase I and pharmacokinetic study of liposomal-irinotecan plus weekly HDFL in refractory solid tumors. (PI, Industry-sponsored, multicentre study, 2006/09 ~ 2008/04) 22.Randomized, phase I and pharmacokinetic study of RAD001, a m-TOR inhibitor, in advanced hepatocellular carcinoma. (PI, PI-initiated, NHRI Cooperative Ward Study, 2007/03 ~ 2009/02) 23.Randomized, phase III trial of adjuvant of therapeutic lamivudine versus prophylactic adefovir in post-operative low-risk HBV-related HCC (PI, PI-initiated, TCOG T1206 Study, 2007/03 ~ 2010/08, early terminated) 24.Randomized Phase I/II of Rapamycin Analog, RAD001, in Advanced Hepatocellular Carcinoma - with a Pharmacokinetic Study of RAD001 (PI, PI-initiated, 2007/12~2014/05) 25.Randomized, phase II trial of docetaxel versus irinotecan versus PEP02 as second-line treatment in advanced gastric cancer (Co-PI, industry-sponsored, international study, 2008/04 ~ 2009/08) 26.Phase II Study of PHY906 plus Capecitabine in Patients with Advanced or Metastatic Hepatocellular Carcinoma (PI, Industry-sponsored, 2008/07~2012/09) 27.Phase I and PK study of sorafenib plus RAD001 in advanced HCC (Co-PI, Industry-sponsored, international study, 2009/02 ~) 28.A Phase II Study of PEP02 as a second line therapy for patients with metastatic pancreatic cancer (Global Chair, Industry-sponsored, 2009/02~2010/09) 29.Phase I and Pharmacokinetic Study of Biweekly PEP02 (Liposome Irinotecan) in Patients with metastatic colorectal cancer refractory to first-line oxaliplatin-based chemotherapy (Co-investigator, Investigator-initiated, 2009/03~2013/05) 30.Randomized, phase III trial of adjuvant of gemcitabine +/- CCRT in pancreatic cancer after curative intent surgery (Chair, PI-initiated, TCOG T3207 Study, 2009/02~ 2015/05, early terminated) 31.EXPAND (Erbitux in combination with Xeloda and Cisplatin in advanced esophago-gastric cancer). Open-label, randomized, controlled, multicenter phase III study investigating cetuximab in combination with capecitabine (Xeloda, X) and cisplatin (P) versus XP alone as first-line treatment for subjects with advanced gastric adenocarcinoma including adenocarcinoma of the gastroesophageal junction. (Co-PI, Industry-sponsored, 2009/05~2012/08) 32.An Open-Label Phase I Dose-Escalation Study of Sorafenib plus S-1 in Advanced Solid Tumors (PI, PI-initiated, 2009/08~2015/06) 33.A randomized phase III, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of everolimus (RAD001) in adult patients with advanced Hepatocellular Carcinoma after failure of sorafenib treatment– The EVOLVE-1 Study (Global co-chair, Industry-sponsored, 2010/09~2012/03) 34.A Randomized phase II study of gemcitabine plus oxaliplatin (GEMOX) with or without cetuximab in locally advanced and metastatic biliary tract cancer (ABTC) (Chair, PI-initiated, 2010/10~2014/09) 35.A Randomized, Double-Blind Placebo-Controlled Phase II Study of the MEK inhibitor GSK1120212 plus Gemcitabine vs. Placebo plus Gemcitabine in Subjects with Metastatic Pancreatic Cancer (Co-PI, Industry-sponsored, 2011/01~2013/12) 36.A phase I dose escalation study of SCB01A in subjects with advanced solid tumors who have failed standard therapy (PI, Industry-sponsored, 2011/01~2015/09) 37.Phase I/II Trial of Biweekly S-1, Leucovorin, Oxaliplatin andGemcitabine (SLOG) in Metastatic Pancreatic Adenocarcinoma (Chair, PI-initiated, 2011/04~2015/08) 38.A Phase II Study of AUY922, a Novel HSP Inhibitor, in Patients with Advanced GIST Failed to or Intolerance of Imatinib and Sunitinib Therapy (PI, PI-initiated, 2011/05~2015/05) 39.A phase I dose escalation trial of weekly intravenous administrations of BI 836845 in patients with advanced solid cancers with repeated administrations in patients showing clinical benefit (PI, Industry-sponsored, 2011/09~) 40.Using genetic polymorphisms of drug metabolism and immunohistochemical stain to predict the efficacy and toxicity in patients with gastric adenocarcinoma - A phase II study (Co-investigator, PI-initiated, 2012/03~) 41.A randomized, open-label phase 3 study of MM-398 versus 5-fluorouracil and leucovorin in patients with metastatic pancreatic cancer (Steering Committee Member, Industry-sponsored, 2012/05~2013/09) 42.Randomized, Open Label, Phase 2 Study of MM-111 and Paclitaxel with or without Trastuzumab in Patients with ‘Traditional’ and ‘Non-Traditional’ HER2 Expressing Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach Who Have Failed Front Line Metastatic or Locally Advanced Therapy (Co-PI, Industry-sponsored, 2013/01~2015/07) 43.A phase II randomized study of induction chemotherapy followed by concurrent chemo-radiotherapy in locally advanced pancreatic cancer (Chair, PI-initiated, 2013/05~) 44.A phase III, open-label, randomized study of the combination therapy with NC-6004 and gemcitabine versus gemcitabine alone in patients with locally advanced or metastatic pancreatic cancer (Global Chair, Industry-sponsored, 2013/10~) 45.Randomized Phase II study of gemcitabine plus Z-360 in metastatic pancreatic adenocarcinoma compared with gemcitabine plus placebo (ZIPANG study) (Global Chair, Industry-sponsored, 2014/05~2014/11) 46.A phase II multicenter, single arm study of oral BGJ398 in adult patients with advanced or metastatic cholangiocarcinoma with FGFR2 gene fusions or other FGFR genetic alterations who failed or are intolerant to platinum-based chemotherapy (Co-PI, Industry-sponsored, 2014/10~) 47.Phase II trial of LDK378 as the first or second-line therapy in ROS1 and /or ALK over-expressed advanced intrahepatic or hilar cholangiocarcinoma (Chair, PI-initiated, 2015/01~) 48.A study of S-1 in combination with gemcitabine as first-line treatment in patients with advanced biliary tract cancer (Chair, Industry-sponsored, 2015/02~2016/02 ) 49.Phase I Trial of ADI-PEG 20 plus cisplatin in patients with metastatic melanoma or other advanced solid malignancies (PI in Taiwan, Industry-sponsored, 2015/03~) 50.ONO-4538-12: Phase III multicenter, open-label, randomized study in patients with un-resectable advanced or recurrent gastric cancer (Steering Committee Member, Industry-sponsored, 2015/11~2016/03) 51.Nanoliposomal irinotecan (nal-IRI)-containing regimens versus nab-paclitaxel plus gemcitabine as first-line therapy in patients with metastatic pancreatic adenocarcinoma (mPAC): a randomized, open-label phase 2 study (PI in NCKUH, Industry-sponsored, 2016/Q2~ ) 52.Randomized, double-blind, phase 2 study of ramucirumab or merestinib or placebo plus cisplatin and gemcitabine as first-line treatment in patients with advanced or metastatic biliary tract cancer (PI in NCKUH, Industry-sponsored, 2016/Q4~ ) 53.A Phase I, open-label, multiple-ascending dose trial to investigate the safety, tolerability, pharmacokinetics, biological and clinical activity of MSB0011359C (M7824) in subjects with metastatic or locally advanced solid tumors with expansion to selected indications in Asia (PI in NCKUH, Industry-sponsored, 2017/Q1~ ) 54.ONO-4538: Phase II multicenter, open-label, randomized study in patients with un-resectable advanced or recurrent gastric cancer (Steering Committee Member, Industry-sponsored, 2017/Q1~ ) 55.Phase 2 study of biweekly gemcitabine plus S-1 and leucovorin (GSL) in elder or ECOG PS>1, advanced pancreatic cancer patients (Chair, PI-initiated, 2018/Q2~) 56.SOLAR trial: an open-label phase I/II, dose-escalation and extension cohort study of biweekly abraxane in combination with oxaliplatin and oral S-1/LV as first-line chemotherapy in patients with advanced gastric, pancreatic and biliary cancers (Chair, PI-initiated, 2018/Q2~) 57.Randomized, phase 2 study of biweekly S-1, leucovorin, oxaliplatin and gemcitabine (SLOG) vs. gemcitabine/cisplatin in advanced biliary tract cancer (Chair, PI-initiated, 2018/Q2~) 58.Randomized, phase 2 study of biweekly S-1, leucovorin, oxaliplatin and gemcitabine (SLOG) vs. modified FOLFIRINOX in advanced pancreatic cancer (Chair, PI-initiated, 2018/Q2~) 59.Phase 2 study of biweekly gemcitabine plus S-1 and leucovorin (GSL) in elder or ECOG PS>1, advanced pancreatic cancer patients (Chair, PI-initiated, 2018/Q2~) 60.Global, phase 3 study of gemcitabine vs. gemcitabine/Endo-Tag in FOLFIRINOX-failed metastatic pancreatic cancer (Global Study Chair, Industry-sponsored, 2018/Q3~)

Dr. Hsu has played an important role in the phase Ib trial of atezolizumab-based combination therapy in patients with locally advanced or metastatic solid tumors (GO30140). The trial has demonstrated the efficacy and safety of atezolizumab plus bevacizumab (atezo/bev) as first-line therapy for patients with unresectable hepatocellular carcinoma (HCC) [Lee MS, Ryoo BY, Hsu CH et al: Lancet Oncol 2020; 21:808-820]. Dr. Hsu gave the oral presentation of this trial at several international conferences, including 2019 APASL and 2019 ESMO-Asia Meetings. The results of this trial prompt the design and conduction of the pivotal phase III IMbrave150 study, which led to establishment of atezo/bev as a new standard first-line systemic therapy for advanced HCC in 2020. Dr. Hsu has been actively participating in several early-phase trials exploring new combination therapy for advanced HCC including MORPHEUS-Liver study. In MORPHEUS-Liver study, the combination of tiragolumab, an anti-TIGIT antibody, with atezo/bev has been shown to exhibit promising efficacies in advanced HCC patients [Finn RS, Ryoo BY, Hsu CH et al: Lancet Oncol. 2025 Feb;26(2):214-226.]. The results of this trial prompt the design and conduction of the phase III IMbrave152 trial to investigate tiragolumab plus atezo/bev versus (vs) atezo/bev as first-line therapy for advanced HCC [NCT05904886]. Dr. Hsu has been actively involved in multiple multinational phase III trials of anti-PD-1 immune checkpoint inhibitors (ICIs) in esophageal cancer. These studies have revolutionized the landscape of systemic therapy for esophageal cancer by demonstrating (1) anti-PD-1 ICIs as a preferred 2nd-line therapy and (2) the combination of an anti-PD-1 ICI plus chemotherapy as a new standard 1st-line therapy for advanced esophageal cancer [Kojima T,…Hsu CH,…et al: J Clin Oncol. 2020; 38:4138- 48, Kato K,…Hsu CH,…et al: Lancet Oncol 2019;20:1506-17, and Doki Y…Hsu CH, … et al: N Engl J Med 2022;386: 449-62]. Dr. Hsu has played an important role in studying anti-TIGIT therapy in the treatment of esophageal squamous cell carcinoma (ESCC). Dr. Hsu gave the oral presentation of the SKYSCRAPER-08 study, an international multicenter phase III trial, investigating tiragolumab plus chemotherapy vs chemotherapy as first-line systemic therapy for advanced ESCC patients, at 2024 ASCO-GI Symposium [Hsu CH et al: ASCO-GI Symposium 2024; Abstract #245; Hsu CH et al: Lancet Oncol. 2026;27(1):103-115.]. He also served as the corresponding author of MORPHEUS-EC trial, which is a randomized phase II trial of tiragolumab plus atezolizumab plus chemotherapy vs atezolizumab plus chemotherapy vs chemotherapy as first-line therapy for advanced ESCC patients [Hsu CH et al: ASCO-GI Symposium: Abstract #324; Sun JM, …., Hsu CH: Lancet Oncol. 2026;27(1):90-102.]. Dr. Hsu has led several investigator-initiated phase II trials, conducted at NTU Hospital, exploring anti-PD-1 ICI treatment as adjuvant for locally advanced ESCC patients [Guo JC, …., Hsu CH. Cancer Immunol Immunother. 2024;73(11):230], anti-PD-1 ICI in combination with chemoradiation as neoadjuvant therapy for locally advanced ESCC patients [Huang TC, …, Hsu CH. Brit J Cancer 2026 accepted for publication], and new anti-PD-1 ICI-based combination therapy in patients with recurrent and metastatic ESCC [Kuo HY, …., Hsu CH. 2022 ASCO-GI Symposium: Abstract #TPS364]. Dr. Hsu has been a member of the Executive Committee of the Asia-Pacific Primary Liver Cancer Expert Association (APPLE Association) since 2017, and served as the Secretary General of the APPLE Association between 2019~2024.

1 Global leading PI:  A Multi-centre Phase II, Double-Blind, Randomised Study of Savolitinib in Combination with Osimertinib vs Savolitinib in Combination with Placebo in Patients with EGFRm+ and MET Amplified Locally Advanced or Metastatic Non-Small Cell Lung Cancer who have Progressed Following Treatment with Osimertinib(NCT04606771) o Drug: Savolitinib  A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) in Participants With Treatment-naïve, Metastatic Nonsmall Cell Lung Cancer (NSCLC) Whose Tumors Have a Tumor Proportion Score (TPS) Greater Than or Equal to 1% (LEAP-007)(NCT03829332) o Drug: Lenvatinib  A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of DZD9008 in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with EGFR or HER2 mutation (NCT03974022) o Drug: DZD9008  A Multicenter, Open-Label Phase 1 Study of DS-1205c in Combination With Osimertinib in Subjects With Metastatic or Unresectable EGFR-Mutant Non-Small Cell Lung Cancer(NCT03255083) o Drug: DS-1205c  A Phase 1, open-label,Multicentre Study to assess the, tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of AZD3759 or AZD9291 in Patients with EGFR Mutation Positive advanced stage NSCLC(NCT02228369) o Drug: AZD3759  A Phase III, Multi-Centre, Open Label, Randomized Study to Assess the Efficacy and Safety of AZD9291 in Combination With MEDI4736 Versus AZD9291 Monotherapy in Patients With Locally Advanced or Metastatic Epidermal Growth Factor Receptor T790M Mutation-positive Non-Small Cell Lung Cancer Who Have Received Prior Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy (CAURAL)(NCT02454933) o Drug: AZD9291 and MEDI4736  LUX-Lung 2: a phase II trial evaluating afatinib in NSCLC patients with EGFR mutations, either treatment-naïve or after one line of treatment with chemotherapy.(NCT00525148) o Drug: BIBW 2992 (Afatinib)  LUX-Lung 1: a phase IIb/III trial investigating afatinib plus best supportive care (BSC) versus placebo plus BSC in NSCLC patients who were previously treated with first-line chemotherapy and the reversible EGFR tyrosine kinase inhibitors (TKIs) erlotinib or gefitinib. (note: gefitinib is not available in the US) (NCT00656136) o Drug: BIBW 2992 (Afatinib)  LUX-Lung 3: a phase III trial investigating afatinib as a first-line treatment in patients with advanced NSCLC with EGFR mutations. (NCT00949650) o Drug: BIBW 2992 (Afatinib) 2 Steering committee member:  A Phase 1/2 Study of NM21-1480 (Anti-PDL-1/Anti-4-1BB/Anti-HSA Tri-Specific Antibody) in Adult Patients With Advanced Solid Tumors (NCT04442126) o Biological: NM21-1480  An Open-label Phase 1/1b Study to Evaluate the Safety and Pharmacokinetics of JNJ-73841937 (Lazertinib), a Third Generation EGFR-TKI, as Monotherapy or in Combinations With JNJ-61186372, a Human Bispecific EGFR and cMet Antibody in Participants With Advanced Non-Small Cell Lung Cancer (NCT04077463), o Drug: Lazertinib and Amivantamab  A Multi-centre Phase II, Double-Blind, Randomised Study of Savolitinib in Combination With Osimertinib vs Savolitinib in Combination With Placebo in Patients With EGFRm+ and MET Amplified Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed Following Treatment With Osimertinib (NCT04606771), o Drug: Savolitinib  A Phase 1/2a, Open-Label, Multi-Center Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of CLN-081 in Patients With Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations (NCT04036682), o Drug: CLN-081  A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 510 Monotherapy in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation and AMG 510 Combination Therapy in Subjects With Advanced NSCLC With KRAS p.G12C Mutation (CodeBreaK 100) (NCT03600883) o Drug: AMG 510  A Phase II, Two-arm Study to Investigate Tepotinib Combined With Osimertinib in MET Amplified, Advanced or Metastatic NSCLC Harboring Activating EGFR Mutations and Having Acquired Resistance to Prior Osimertinib Therapy (INSIGHT 2) (NCT03940703) o Drug: Tepotinib  A Phase 1/2 Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of the Oral EGFR/HER2 Inhibitor TAK-788 (AP32788) in Non-Small Cell Lung Cancer(NCT02716116) o Drug: TAK-788  A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Canakinumab in Combination With Docetaxel Versus Placebo in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancer (NSCLC) Previously Treated With PD-(L)1 Inhibitors and Platinum-based Chemotherapy (CANOPY 2)(NCT03626545) o Drug: Canakinumab  A Phase 3 Randomized Open-label Study of Brigatinib (ALUNBRIG®) Versus Alectinib (ALECENSA®) in Advanced Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer Patients Who Have Progressed on Crizotinib (XALKORI®)(NCT03596866) o Drug: Brigatinib  Phase II, Open Label, Single Arm Study of the Efficacy and Safety of Crizotinib in East Asian Patients With Advanced ALK-Negative NSCLC Harboring a Translocation or Inversion Involving the c-ROS Oncogene (ROS1) Locus (NCT01945021) o Drug: Crizotinib  A Phase 2 Precision Oncology Study of Biomarker-Directed, Pembrolizumab-(MK-3475, SCH 900475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (KEYNOTE-495; KeyImPaCT)( (NCT03516981) o Drug: Lenvatinib and Pembrolizumab  A Phase 1/2, Open-label, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10296 in Patients With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer(NCT02981108) o Drug: HS-10296  LUX-Lung 7 (Clinical Trial Identifier NCT01466660): a phase IIb trial evaluating afatinib head-to-head versus gefitinib as a first-line treatment in patients with advanced NSCLC with EGFR mutations. o Drug: Afatinib  A Study of Nivolumab + Chemotherapy or Nivolumab + Ipilimumab Versus Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Who Failed 1L or 2L EGFR Tyrosine Kinase Inhibitor (TKI) Therapy (CheckMate722) (NCT02864251) o Drug: Nivolumab + Ipilimumab 3 Advisory board:  A Phase I, Open-label, Non-randomised Study to Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of a Single Oral Dose of AZD9291 in Patients With EGFRm Positive NSCLC Whose Disease Has Progressed on an EGFR TKI (NCT02157883) o Drug: AZD9291  An Open-label, Randomized Phase 3 Efficacy Study of ASP8273 vs Erlotinib or Gefitinib in First-line Treatment of Patients With Stage IIIB/IV Non-small Cell Lung Cancer Tumors With EGFR Activating Mutations (NCT02588261) o Drug: ASP8273  A Phase I/II, Multicenter, Open-label Study of EGFRmut-TKI EGF816, Administered Orally in Adult Patients With EGFRmut Solid Malignancies (NCT02108964) o Drug: EGF816  A Phase III, Open-label, Multicenter Trial of Avelumab (MSB0010718C) Versus Platinum-based Doublet as a First-line Treatment of Recurrent or Stage IV PD-L1+NSCLC (NCT02576574) o Drug: Avelumab  GioTag: Real-world Data Study on Sequential Therapy With Gi(l)Otrif®/ Afatinib as First-line Treatment Followed by Osimertinib in Patients With EGFR Mutation Positive Advanced Non-small Cell Lung Cancer (NCT03370770) o Drug: Afatinib  A phase I/II study of Pembrolizumab (MK-3475) in Combination With Chemotherapy or Immunotherapy in Participants With Lung Cancer (MK-3475-021/KEYNOTE-021)　(NCT02039674) o Drug: Pembrolizumab  A phase I/II, multicenter, open-label study of EGF816(EGFR-TKI) in adult patients with EGFR-mutant solid malignancies(NCT02108964) o Drug: EGF816  Phase 2, open-label, single-arm study of the efficacy and safety of CRIZOTINIB in east asian patients with advanced ALK-negative non-small cell lung cancer (NSCLC) harboring a translocation or inversion involving the c-ros oncogene (ROS1) locus (NCT01945021) o drug: Crizotinib  Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of AZD9291 in Patients With Advanced Non Small Cell Lung Cancer Who Progressed on Prior Therapy With an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Agent (NCT01802632) o Drug: AZD9291  A Phase IB/II, Open Label, Multicenter Study of INC280 Administered Orally in Combination With Gefitinib in Adult Patients With EGFR Mutated, c-MET-amplified Non-small Cell Lung Cancer Who Have Progressed After EGFR Inhibitor Treatment (NCT01610336) o Drug: INC280 4 Involved in or cooperated with international organizations, conferences 5 Invited Reviewer of Manuscripts: New England Journal of Medicine, Lancet Oncology, Lancet Respiratory Medicine, Journal of Clinical Oncology, Nature Communication, Journal of Thoracic oncology, Cancer Research, Clinical Cancer Research, Lung Cancer, Urologic Oncology, Cancer Letter 6 Highly cited researcher of 2019 and 2020 in Clinical Medicine category awarded by Clarivate Analytics (Web of Science Group). World’s Top 2% Scientists 2020 and the 4th scientist among the Taiwanese Top 2% Scientists 2020.

1 (1) Establishment of clinical practice guidelines for the prevention of hepatitis B virus (HBV) reactivation in cancer patients who received immuno-suppressive therapy. Dr. Hsu is a world-renown leader in this field who helped establish clinical practice guidelines in the world for the prevention and treatment of this life-threatening complication. Dr. Hsu led a series of prospective, multi-center clinical trials in Taiwan to characterize the risk and severity of HBV reactivation in cancer patients who had chronic or resolved HBV infection and to define the optimal preventive strategy. Results of these trials also constituted the basis of current insurance reimbursement policy of prophylactic HBV antiviral therapy in Taiwan. (2) Development of immune checkpoint inhibitor (ICI) therapy for patients with Asian endemic cancers. Dr. Hsu is the first investigator in the world who reported the promising antitumor activity of the anti-PD-1 ICI pembrolizumab for patients with advanced nasopharyngeal carcinoma. Dr. Hsu also served as the senior author of the global, randomized trial of nivolumab (anti-PD1 ICI) plus ipilimumab (anti-CTLA4 ICI) for advanced hepatocellular carcinoma (HCC), which led to approval of this regimen by U.S. FDA in March 2020 for the treatment of patients with advanced HCC following sorafenib therapy. (3) Key opinion leader in translational research for the optimal biologically effective dosage of cancer immunotherapy. By using multi-kinase inhibitors (MKI) for the treatment of HCC as a model, Dr. Hsu has established pre-clinical platforms to define the optimal biologically effective dosage of MKI as immune modulatory agents. The results provide mechanistic basis for rational design of combination immunotherapy and led to a proof-of-concept clinical trial for advanced HCC (clinicaltrials.gov identifier: NCT04183088) 2 A Phase 1/2, Dose-escalation, Open-label, Non-comparative Study of Nivolumab or Nivolumab in Combination with Ipilimumab in Advanced Hepatocellular Carcinoma Subjects with or without Chronic Viral Hepatitis; and a Randomized, Open-label Study of Nivolumab vs Sorafenib in Advanced Hepatocellular Carcinoma Subjects who are Naive to Systemic Therapy(US FDA accelerated approval in 2020) 3 Nivolumab plus ipilimumab as neoadjuvant therapy for hepatocellular carcinoma (HCC) 4 Atezolizumab plus bevacizumab for patients with advanced hepatocellular carcinoma (HCC) and chronic hepatitis B virus (HBV) infection 5 A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) with Pembrolizumab (MK-3475) in Combination with Transarterial Chemoembolization (TACE) Versus TACE in Participants with Incurable/Non-metastatic Hepatocellular Carcinoma (LEAP-012) 6 A Phase 2, Randomized, Open-labeled Clinical Study Investigating the Efficacy and Safety of Ociperlimab in Combination With Tislelizumab Plus BAT1706 and of Tislelizumab Plus BAT1706 as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma 7 A Phase 3 Randomized, Double Blind Study of Pembrolizumab Plus Gemcitabine/Cisplatin versus Placebo Plus Gemcitabine/Cisplatin as First-Line Therapy in Participants with Advanced and/or Unresectable Biliary Tract Carcinoma 8 A Randomized, Open-Label, International, MultiCenter, Phase 3 Clinical Study of PD-1 Antibody SHR-1210 Plus Apatinib (Rivoceranib) Mesylate Versus Sorafenib as First-Line Therapy in Subjects with Advanced Hepatocellular Carcinoma (HCC) Who Have Not Previously Received Systemic Therapy 9 A Phase 3 Double-blinded, Two-arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) versus Placebo as Adjuvant Therapy in Participants with Hepatocellular Carcinoma and Complete Radiological Response after Surgical Resection or Local Ablation (KEYNOTE-937) 10 Combination of GT90001 and Nivolumab in Patients with Metastatic Hepatocellular Carcinoma 11 A randomized, double-blind, phase III study comparing NIS793 in combination with gemcitabine and nab-paclitaxel versus placebo combined with gemcitabine and nabpaclitaxel for first line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC) 12 Open-Label, Multicenter, Phase II/III Study of Combination Therapy of D07001-Softgel Capsules and Xeloda/TS-1 in Subjects with Advanced Biliary Tract Cancer after Gemcitabine and Cisplatin-Based Treatment Failure

1 Global leading PI, steering committee chair: A Phase III randomized, double-blind, placebo-controlled study of LEE011 or placebo in combination with tamoxifen and goserelin or a non-steroidal aromatase inhibitor (NSAI) and goserelin for the treatment of premenopausal women with hormone receptor positive, HER2-negative, advanced breast cancer (MONALEESA-7) 2 Global leading PI, steering committee chair: A phase II randomized study of the combination of Ribociclib plus goserelin acetate with Hormonal Therapy versus physician choice chemotherapy in premenopausal or perimenopausal patients with hormone receptor-positive/HER2-negative inoperable locally advanced or metastatic breast cancer (RIGHT Choice) 3 Global leading PI (regional multi-country) trial, steering committee chair: A phase Ib study of the combination of Tamoxifen plus Goserelin Acetate with BYL719 or Buparlisib (BKM120) in premenopausal patients with hormone receptor-positive/HER2-negative locally advanced or metastatic breast cancer (BYOND) 4 Member of Scientific Committee, TRIO (Translational Research in Oncology) 2019-presnet 5 Design and conduct one of the most effective regimen BEEP for breast cancer with brain metastases and breast cancer with leptomeningeal metastases. 1. A phase II study of Bevacizumab with Etoposide and Cisplatin in breast cancer patients with brain and/or leptomeningeal metastasis (BEEP study), 2. Randomized phase II study of induction Bevacizumab, Etoposide and Cisplatin followed by whole brain radiotherapy versus radiotherapy alone in breast cancer with untreated brain metastases (A-Plus study)

1 Global leading PI A Double-blind, Randomized Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Subjects With Metastatic Breast Cancer (OPT-822-001) All Meta 1st line & 2nd line 2 Global leading PI A Phase III, Randomized, Multicenter, Double-blind Study to Compare Efficacy and Safety of EG12014 (EirGenix Trastuzumab) with Herceptin® as Neoadjuvant Treatment in Combination with Anthracycline/Paclitaxel-based Systemic Therapy in Patients with HER2‑positive Early Breast Cancer (EGC002) HER2+ neoadjuvant 3 Steering Committee TRIO033: A phase III, multicenter, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, early breast cancer (New Adjuvant Trial with Ribociclib [LEE011]: (NATALEE) HER2-adjuvant 4 Steering Committee KBCRN-B003/OOTR-N016: A Phase III Randomized, Double-Blind, Neoadjuvant Study of Hormonal Therapy plus Palbociclib versus Hormonal Therapy plus Placebo in Women with Operable, Hormone Sensitive and HER2-Negative Primary Breast Cancer ER+/HER2-neoadjuvant 5 Steering Committee A Phase III, Randomized, Double-blind, Placebo Controlled Study of Adagloxad Simolenin (OBI 822)/OBI 821 Treatment for High Risk Early Stage Triple Negative Breast Cancer Patients, defined as Residual Invasive Disease following Neoadjuvant Chemotherapy OR ≥4 Positive Axillary Nodes TNBC adjuvant 6 Steering Committee NeoTRIPaPDL1: Neo-Adjuvant study with the PDL1-directed antibody in Triple Negative Locally Advanced Breast Cancer undergoing treatment with nab-paclitaxel and carboplatin. TNBC neoadjuvant 7 Steering Committee Katherine: A randomized, multicenter, open-label phase III study to evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy for patients with her2-positive primary breast cancer who have resudual tumor present pathologically in the breast or axillary lymph nodes following preoperative therapy HER2+ adjuvant 8 Steering Committee Kristine: A randomized, multicenter, open-label, five-arm, phase iii neoadjuvant study evaluating trastuzumab emtansine and pertuzumab alone or in combination with chemotherapy for patients with her2-positive breast cancer. HER2+ neoadjuvant 9 Advisory board (for pharma investigating drug) Boehringer Ingelheim - Afatinib (Giotrif® 妥復克) 10 Advisory board (for pharma investigating drug) Amgen – Demosumab (Prolia® 保骼麗) 11 Advisory board (for pharma investigating drug) Pfizer – Palbociclib (Ibrance® 愛乳適) 12 Advisory board (for pharma investigating drug) Eli Lilly - Abemaciclib (Verzenio® 捷癌寧) 13 Advisory board (for pharma investigating drug) OBI Pharma – Globo H 疫苗 (Trial: OPT-822-001) 14 Conduct clinical trials of new drugs and bring a New Drug to the Market A randomized, multicenter, open-label phase III study to evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy for patients with her2-positive primary breast cancer who have resudual tumor present pathologically in the breast or axillary lymph nodes following preoperative therapy (KATHERINE) T-DM1(trastuzumab emtansine Kadcyla® 賀癌寧) 15 Conduct clinical trials of new drugs and bring a New Drug to the Market A Randomized Three-Arm, Multicenter Comparison of 1 Year and 2 Years of Herceptin Versus No Herceptin in Women With HER2-Positive Primary Breast Cancer Who Have Completed Adjuvant Chemotherapy (HERA) Trastuzumab Herceptin® 賀癌平 16 Conduct clinical trials of new drugs and bring a New Drug to the Market A randomized, multicenter, open-label, five-arm, phase iii neoadjuvant study evaluating trastuzumab emtansine and pertuzumab alone or in combination with chemotherapy for patients with her2-positive breast cancer. (KRISTINE)

1. Country principal Investigator: A Phase II, Single Arm, Multicenter Open Label Trial to Determine the Efficacy and Safety of Tisagenlecleucel (CTL019) in Adult Patients with Refractory or Relapsed Follicular Lymphoma. (Clinicaltrials.gov Identifier: NCT03568461) 2. Country principal Investigator: Tisagenlecleucel versus standard of care in adult patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma: A randomized, open label, phase III trial (BELINDA). (Clinicaltrials.gov Identifier: NCT03570892) 3. Country principal Investigator: Long Term Follow-Up of Patients Exposed to Lentiviral- Based CAR T-Cell Therapy. (Clinicaltrials.gov Identifier: NCT02445222) 4. Country Sub-Investigator: Infusion of CD19-Specific Chimeric Antigen Receptor T Cells Produced by Rapid Personalized Manufacture for Patients with Advanced Lymphoid Malignancies. (Clinicaltrials.gov Identifier: NCT 04844086) 5. Country Sub-Investigator: A Phase 1/2 multicenter, open-label, single-arm study to evaluate the safety and efficacy of CD19-targeted chimeric antigen receptor T-cell (CD19 CAR-T) therapy in patients with relapsed or refractory B-cell lymphoma. (NTUH IRB Number: 202103027DSC)

1 Steering committee member and leading investigator: A Phase I/Ib, Open-Label Study of Pevonedistat (MLN4924) as Single Agent and in Combination with Azacitidine in Adult Asian Patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome (ClinicalTrials.gov Identifier: NCT02782468) 2 Country principal Investigator: Infusion of CD19-Specific Chimeric Antigen Receptor T Cells Produced by Rapid Personalized Manufacture for Patients with Advanced Lymphoid Malignancies. (Clinicaltrials.gov Identifier: NCT04844086) 3 Country principal Investigator: A Phase 1/2 multicenter, open-label, single-arm study to evaluate the safety and efficacy of CD19-targeted chimeric antigen receptor T-cell (CD19 CAR-T) therapy in patients with relapsed or refractory B-cell lymphoma. (NTUH IRB Number: 202103027DSC) 4 Country Sub-Investigator: Tisagenlecleucel versus standard of care in adult patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma: A randomized, open label, phase III trial (BELINDA). (Clinicaltrials.gov Identifier: NCT03570892) 5 Country Sub-Investigator: A Phase II, Single Arm, Multicenter Open Label Trial to Determine the Efficacy and Safety of Tisagenlecleucel (CTL019) in Adult Patients with Refractory or Relapsed Follicular Lymphoma. (Clinicaltrials.gov Identifier: NCT03568461) 6 Expert panelist: Measurable residual disease in chronic lymphocytic leukemia: expert review and consensus recommendations. Leukemia. 2021 Nov;35(11):3059-3072.

1. Dr. Chen is the Asian PI that participated in the pivotal clinical trial that led to the approval of tazemetostat, a first-of-its-kind EZH2 inhibitor, for advanced epithelioid sarcoma by the US FDA. The results of this pivotal study was published in Lancet Oncology. 2. Dr. Chen is the PI of the study of pexidartinib and with his expertise testimony helped the approval of pexidartinib by Taiwan FDA. At present, only the US, South Korea, and Taiwan have approved pexidartinib for inoperable tenosynovial giant cell tumor. Dr. Chen is also one of the experts invited to be an author of the article: Best clinical management of tenosynovial giant cell tumour (TGCT): A consensus paper from the community of experts. 3. One of the Advisory Board Member and PIs of the new MDM2 inhibitor brigimadlin (BI907828) for global pivotal phase III trial of advanced dedifferentiated liposarcoma. 4. The PI of the investigator initiated clinical trial—LEADER, which investigated the efficacy of the combination of lenvatinib and eribulin in advanced leiomyosarcoma and liposarcoma. The results were presented as oral abstracts in both American Clinical Oncology Society (ASCO) Annual Meeting and the European Society of Medical Oncology (ESMO) Congress meeting. The full paper was published in the journal Clinical Cancer Research. 5. National Taiwan University Hospital and the PI Dr. Chen is the only site in Asia selected as one of the collaborators with the Spanish Sarcoma Group on the international GEIS75 clinical trial. 6. Dr. Chen was involved in the design and execution of the A-PLUS clinical trial, which is a randomized phase II study investigating the benefit of induction bevacizumab-based chemotherapy (BEEP regimen) followed by whole-brain radiotherapy in breast cancer with brain metastasis. The results reached the primary endpoint and showed the induction BEEP followed by WBRT is better than WBRT in controlling the brain metastatic tumors. The results were published in the prominent journal JAMA Oncology. 7. Dr. Chen is one of the experts in the development of the Pan-Asian adapted ESMO Clinical Practice Guidelines for Early Breast Cancer 2023. 8. Dr. Chen is the Chair of the Sarcoma Scientific Committee of the 2019 ESMO Asia and 2022 ESMO Congress meeting; 9. Dr. Chen is a Board Member of the Asian Clinical Trials Network for Cancer Project (ATLAS) that was funded by Japan Agency for Medical Research and Development.