1 鄭教授以國際領導者的地位，先後主持多項重要藥物的跨國大型臨床試驗，包括sorafenib，sunitinib，dovitinib，tigatuzumab，cabozantinib，lenvatinib，及atezolizuman。在上述研究中担任全球總主持人。 2 2009年，擔任肝癌標靶藥物sorafenib在亞太地區進行的臨床試驗總主持人，其研究証實sorafenib可以顯著延長晚期肝癌患者的總存活率。該藥隨即獲得FDA及全球認証，成為第一個肝癌治療藥物。 3 2017年，鄭教授主持之誇國大型臨床試驗lenvatinib在第一線治療有優於sorafenib的臨床表現，鄭教授於2017年6月美國臨床腫瘤醫學會(ASCO)，代表全球專家學者，宣佈其結果。隨即在Lancet以資深作者身份發表，成為標靶治療時代最重要的突破。 4 2019年，鄭教授以atezolizumab (anti-PDL1) + bevacizumab (anti-VEGF)之複合處方逕行全球三期大型臨床試驗，即著名的IMbravel150研究，並担任全球總主持人。該研究是十年來肝癌最大的突破。鄭教授代表全球學者於2019年12月在國際學會上宣讀結果，論文隨即被NEJM接受刊載。目前是全世界公認的標準治療。 5 2012：Member of Governing Board, International Liver Cancer Association (ILCA) 6 2017：President, APPLE (Asia Pacific Primary Liver Cancer Expert Meeting) Society 7 2020：Blue Faery Award for Excellence in Liver Cancer Research, U.S.A. 8 2020, 2023：National Taiwan University Distinguished Chair Professor(台灣大學特聘講座教授). 9 2021~2024：Clarivate Analytics Highly Cited Researchers (科睿唯安評比全球高引用學者).

如描述。

1. 『晚期肝細胞癌(Advanced HCC)』藥物治療的臨床及轉譯研究： (A).分子標靶治療（molecularly targeted therapy）到免疫檢查點抑制劑（immune checkpoint in-hibitors, ICIs）臨床研究的推展： 肝細胞癌的藥物治療自2007年起進入『標靶治療』的年代，徐醫師曾主導多個臨床試驗，以抗血管新生標靶藥物合併metronomic chemotherapy (Hsu CH et al: Brit J Cancer 2010;102:981-; Hsu CH et al: J Hepatol 2010;53:126-; Shao YY et al: Oncol 2012;82:59- [徐醫師為通訊作者])、或合併EGFR抑制劑 (Hsu CH et al: Oncology 2013; 85: 44-)提升療效。台大醫院團隊在鄭安理教授帶領之下，已是肝細胞癌藥物臨床研究全球最重要的中心。 肝細胞癌的藥物治療自2018年起進入以ICI為主的『免疫治療』年代，台大醫院團隊持續在重要的大型跨國臨床試驗扮演重要角色；但徐醫師更著重於『早期臨床試驗』及轉譯研究。徐醫師是GO30140早期臨床試驗案的主要研究者，該試驗證實atezolizumab+bevacizumab(atezo/bev)在晚期肝細胞癌病患的安全性及有效性(Lee MS, Ryoo BY, Hsu CH et al: Lancet Oncol 2020; 21:808-)，徐醫師也曾代表試驗團隊於亞太國際會議進行口頭報告 (2019 APASL及2019 ESMO-Asia)。因為此一試驗的正面的結果，促成後續IMbrave150第三期試驗的執行和成功，奠定atezo/bev為晚期肝細胞癌嶄新的第一線藥物治療。 2022年後，徐醫師持續參與肝細胞癌藥物早期臨床試驗如MORPHEUS-Liver試驗案，以新穎的試驗設計，測試多個藥物或策略以提升atezo/bev的療效，因為我們的努力（Finn RS, Ryoo BY, HsuCH et al; Lancet On-col 2024 (accepted)），發現atezo/bev加上tiragolumab的三藥組合有更佳的療效，因而促成IMbrave 152大型跨國第三期臨床試驗的執行。 (B). 肝細胞癌的臨床前期研究以探索肝細胞藥物治療抗藥性機制並研發嶄新的治療策略： 透過實驗室建立sorafenib-resistant肝癌細胞株及病患血清檢體的研究，我們發現：TGF-β1可能是sorafenib抗藥性的機轉 (Lin TH et al: Clin Cancer Res 2015; 21:3678- [徐醫師為通訊作者])。與腫瘤所張純榮老師合作，以免疫健全小鼠肝癌的研究模式探討腫瘤的免疫微環境，我們發現：小鼠肝癌經sorafenib 治療後，腫瘤內增加的myeloid- derived suppressor cells(MDSCs)是引起抗藥性的重要機轉；若以anti-IL6R或anti-Ly6G去除MDSCs，可加強sorafenib的療效 (Chang CJ et al: Int J Cancer 2018;142:1878- [徐醫師為通訊作者])。 自2022年起，除了針對肝細胞癌病患腫瘤檢體進行atezo/bev療效預測及抗藥性機轉的研究 (Wang Y et al: Exp Hema Oncol 2021; 10:45[徐醫師為通訊作者]；Zhx Ax et al: Nature Med 2022;28:1599- [本人為作者之一])，徐醫師也與劉宗灝醫師建立了免疫健全小鼠對anti-VEGF及anti-PD-L1（模擬臨床病患接受atezo/bev）抗藥性的動物模式，正積極研究其抗藥性機轉及反轉抗藥性的可能策略。 2. 『食道癌（Esophageal cancer）』藥物治療學的臨床及轉譯研究： (A). 參與並領導食道癌免疫治療藥物大型跨國第三期臨床試驗： 自2019年起，以抗PD-1為主的ICI免疫治療藥物，經數個大型第三期臨床試驗證實為晚期食道癌優於化學治療的第二線治療選項； 2022年起，抗PD-1 ICI免疫治療藥物加上化學治療，經多個第三期臨床試驗證實為食道癌更有效的第一線治療。在許多個第三期臨床試驗，徐醫師帶領台灣學者積極參與，扮演重要角色（Kojima T et al: JCO 2020;38:4138-, Kato K et al: Lancet Oncol 2019;20:1506-, Doki Y et al: New Engl J Med 2022;386:449-[徐醫師均為作者之一]）。 在探尋新一代免疫治療藥物的臨床研發上，徐醫師領導了多個anti-TIGIT藥物於食道癌的跨國第二期及第三期臨床試驗，並代表研究團隊於國際學會中發表試驗的成果(Hsu CH et al: 2024 ASCO-GI abstract #245 [於大會進行口頭報告], Sun JM et al: 2024 ASCO-GI abstract #324[徐醫師為通訊作者], Hsu CH et al: 2024 ESMO-GI abstract #401P [poster discussion])。 (B). 臨床轉譯研究以研發食道癌病患接受免疫治療療效的生物標記： 針對局部擴散型食道癌檢體的分析，我們發現腫瘤內免疫細胞表達PD-L1者有較好的預後；反之，腫瘤內癌細胞表達PD-L1者的預後較差(Huang TC et al: J Cancer Res Clin Oncol 2022: 148:1803- [徐醫師為通訊作者])。針對接受抗PD-1 ICI免疫治療藥物的食道癌病患，經系統性地探索可預測ICI治療的預測或預後因子，我們發現：食道癌腫瘤組織的B cell signatures（Guo JC et al: Front Oncol 2022; 12:879398 [徐醫師為通訊作者]）、DNA damage and repair (DDR) genes的deleterious mutation（Guo JC et al: Esophagus 2022; 19:693-1 [徐醫師為通訊作者]）與病患獲得ICI治療的助益和病患較好的存活期相關。目前，我們持續進行食道癌免疫治療相關生物標記的轉譯研究，並執行數個研究者自行發起研究案，以擴展免疫治療在食道癌治療學上更多的應用。

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.