drugset / Trial / NCT04523493
Phase III Study of Toripalimab（JS001） Combined With Lenvatinib for Advanced HCC
RandomizedFactorialQuadruple-blindTreatment
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).
Timeline
- Start
- 2020-06-29
- Primary completion
- 2026-12-31
- Completion
- 2027-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Toripalimab | Monoclonal antibody | 240 mg | Intravenous |
| Background | Lenvatinib | Small molecule | 8 mg | Oral |
| Background | Lenvatinib | Small molecule | 12 mg | Oral |