NCT04523493

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

A Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter Phase III Study to Compare Toripalimab Combined With Lenvatinib Versus Placebo Combined With Lenvatinib as the 1st-line Therapy for Advanced HCC

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 530 (actual)
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Advanced Hepatocellular Carcinoma (HCC)

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Toripalimab combined with Lenvatinib	Experimental group: Toripalimab, 240mg, IV infusion, every 3 weeks (q3w). combined with Lenvatinib 12 mg/day (Body Weight≥60 kg) or 8 mg/day (Body Weight\<60 kg) oral administration, once daily. Continuous infusion, in a cycle of 3 weeks (21 days), until occurrence of termination event specified in the protocol.
COMBINATION_PRODUCT	Placebo combined with Lenvatinib	Control group: Placebo, one unit, IV infusion, once every 3 weeks, combined with Lenvatinib 12 mg/day (Body Weight≥60 kg) or 8 mg/day (Body Weight\<60 kg) oral administration, once daily. Continuous infusion, in a cycle of 3 weeks (21 days), until occurrence of termination event specified in the protocol.

Timeline

• Start date: 2020-06-29
• Primary completion: 2025-12-31
• Completion: 2026-09-01
• First posted: 2020-08-21
• Last updated: 2025-12-09

Locations

22 sites across 5 countries: China, Italy, Poland, Singapore, Ukraine

Regulatory

• FDA-regulated drug study