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Toripalimab or Placebo as Adjuvant Therapy in Hepatocellular Carcinoma After Radical Resection
Sponsor: Shanghai Junshi Bioscience Co., Ltd.
Summary
This study will investigate if Toripalimab (A PD-1 Inhibitor) will improve recurrence-free survival (RFS) compared to placebo in participants with HCC and are at high risk of recurrence after complete resection with no residual of tumour.
Official title: A Phase II/III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Toripalimab (Recombinant Humanized Anti-PD-1 Monoclonal Antibody, JS001) Versus Placebo as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence Following Radical Resection
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
427
Start Date
2019-03-05
Completion Date
2027-12-31
Last Updated
2026-08-10
Healthy Volunteers
No
Conditions
Interventions
TORIPALIMAB INJECTION(JS001 )
Arm A: Toripalimab 240mg IV(Injection of Vein) Q3W Arm B: Placebo 240mg IV(Injection of Vein) Q3W
Locations (1)
Zhongshan Hospital,Fudan University
Shanghai, Shanghai Municipality, China