Clinical Trial

Phase III Study of Toripalimab（JS001） Combined With Lenvatinib for Advanced HCC

Active, Not Recruiting Phase 3
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Summary
This is a prospective, randomized, placebo-controlled, double-blind, multicenter phase III registration clinical study to observe, compare and evaluate the efficacy and safety of Toripalimab combined with Lenvatinib versus placebo combined with Lenvatinib as the 1st-line therapy for advanced HCC. Eligible subjects will be randomized at a ratio of 2:1 to receive Toripalimab combined with Lenvatinib (experimental group) or Placebo combined with Lenvatinib (control group).
Protocol Amendment History 12 amendments
This ClinicalTrials.gov record has been amended 12 times since 2020-08-19; most recent amendment 2026-07-02.
Status change: Recruiting → Active, Not Recruiting 2023-07-18
Trial Details
NCT Number NCT04523493
Lead Sponsor Shanghai Junshi Bioscience Co., Ltd.
Conditions Advanced Hepatocellular Carcinoma (HCC)
Enrollment 530 participants
Start Date 2020-06-29
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-06