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