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

Phase 3

Active, not recruiting

• Conditions: Advanced Hepatocellular Carcinoma (HCC)

• Registration Number: NCT04523493
• Lead Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-29
• Study First Submitted: 2020-07-09
• Study First Submitted QC: 2020-08-19
• Study First Posted: 2020-08-21
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-10
• Last Update Posted: 2025-07-14
• Primary Completion: 2025-12-31
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 530

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	Up to 3 years	The time from randomization to death for any reason.

Secondary Outcome Measures

Name	Time	Method
PFS rate	Up to 3 years	The PFS rate on 6 months and 1year in both groups.
Progression-free survival (PFS)	Up to 3 years	The time from randomization to progression of disease or death for any reason, whichever comes first. Progression of disease will be evaluated
PK	To be collected once within 60 minutes prior to administration each for Toripalimab/placebo on Day 1 of Cycle (each cycle is 21 days). but the no-china sites not collection the sample	According to the test of blood samples, the pharmacokinetic parameters of Toripalimab, mainly trough concentration, will be analyzed.
Immunogenicity	Up to 3 years	Plasma level of anti-Toripalimab injection (JS001) antibody, immunoglobulin and Toripalimab injection (JS001) will be summarized descriptively.
TTP	Up to 3 years	Defined as the time from randomization to objective tumor progression.
OS rate	Up to 3 years	The OS rate on 1year and 2years in both groups.
ORR	Up to 3 years	Defined as the proportion of subjects with the best overall response of complete response (CR) or partial response (PR).
Duration of Response (DOR)	Up to 3 years	Defined as the time from the first evaluation of CR or PR to the first evaluation of PD or death for any reason.
DCR	Up to 3 years	Defined as the proportion of subjects with the best overall response (BOR) of CR, PR or SD.
Incidence,severity and prognosis of AEs/SAEs as assessed by NCI-CTCAE v5.0	From date of consent informed until 90 days after the last investigational product administration. Up to 2 approximately years.	Verbatim descriptions of adverse events will correspond to MedDRA synonymous terms, and AEs will be graded in accordance with NCI-CTCAE version 5.0. All the adverse events during or after the first dose of study drug will be summarized by treatment groups and NCI CTCAE grade. In addition, serious adverse events, adverse events (grade 3 or above) and the adverse events leading to discontinuation or suspension of study drug will be summarized correspondingly. Multiple occurrence of the same event will be counted once in accordance with the highest severity. The proportion of subjects with at least one adverse event will be reported by term of toxicity and treatment groups.

Trial Locations

Locations (23)

Qinhuai Medical Area, General Hospital of PLA Eastern Theater Command; 🇨🇳 Nanjing, Jiangsu, China

Azienda Ospedaliera Universitaria Careggi; 🇮🇹 Firenze, Italy

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico,Oncologia Medica; 🇮🇹 Milan, Italy

IRCCS Fondazione Giovanni Pascale, Istituto Nazionale Dei Tumori; 🇮🇹 Napoli, Italy

Azienda Ospedaliero Universitaria Pisana; 🇮🇹 Pisa, Italy

A.O.U. Citta della Salute e della Scienza di Torino; 🇮🇹 Tortona, Italy

AOUI Verona - Policlinico "G.B. Rossi" di Borgo Roma; 🇮🇹 Verona, Italy

Copernicus Podmiot Leczniczy sp. z o.o., Wojewodzkie Centrum Onkologii, Oddzial Onkologii Klinicznej/Chemioterapii; 🇵🇱 Gdansk, Poland

Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie, Oddzial Dzienny Chemioterapii; 🇵🇱 Koszalin, Poland

PRATIA MCM Kraków, ul. Pana Tadeusza 2,; 🇵🇱 Krakow, Poland

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