Toripalimab in Combination With Lenvatinib as Neoadjuvant Therapy in Resectable Hepatocellular Carcinoma

Phase 1

Terminated

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Toripalimab (JS001 ) Lenvatinib; Drug: Toripalimab (JS001 )

• Registration Number: NCT03867370
• Lead Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Brief Summary

This study will evaluate efficacy and safety of Toripalimab Injection (JS001) with or without Lenvatinib as a Neoadjuvant Therapy in patients with Resectable Hepatocellular Carcinoma (HCC)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-01
• Study First Submitted QC: 2019-03-05
• Study First Posted: 2019-03-08
• Study Start: 2019-04-26
• Primary Completion: 2023-08-08
• Study Completion: 2023-08-08
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-24
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Patients who previously received anti-programmed death receptor-1 (PD-1) antibody, anti-programmed death ligand-1 (PD-L1) antibody, anti-programmed death ligand-2 (PD-L2) antibody or anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibodies, including those who have participated in a JS001 clinical study;

Patients with a history of gastroesophageal varices or active cardia ulcers associated with a high risk of bleeding; Patients who have upper gastrointestinal hemorrhage within 1 year; Patients known to have fibrous layer HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC; Other protocol defined inclusion/exclusion criteria could apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Group B (Toripalimab, Lenvatinib)	Toripalimab (JS001 ) Lenvatinib	During the neoadjuvant period, the patients will receive a single dose JS001 intravenous infusion of 480 mg in combination with oral lenvatinib at a starting dose of 8 or 12 mg once a day. After the operation, the patients will receive JS001 240 mg Q3W and lenvatinib for up to 48 weeks.
Group A	Toripalimab (JS001 )	During the neoadjuvant period, the patients will receive a single dose JS001 intravenous infusion of 480 mg. After the operation, the patients will receive JS001 240 mg Q3W for up to 48 weeks.
Group C (Toripalimab, Lenvatinib)	Toripalimab (JS001 ) Lenvatinib	During the neoadjuvant period, the patients will receive a single dose JS001 intravenous infusion of 480 mg in combination with oral lenvatinib at a starting dose of 8 or 12 mg once a day. After the operation, the patients will receive JS001 240 mg Q3W for up to 48 weeks.

Primary Outcome Measures

Name	Time	Method
Pathological response rate	Up to 2 months	CPR，MPR

Secondary Outcome Measures

Name	Time	Method
Time to operation	up to 8 months	Used for assessment of the feasibility of the neoadjuvant therapy.
Progression free survival	up to 3 years	Used for assessment of the efficacy.
Objective response rate	up to 2 months	ORR is defined as the percentage of participants who achieved CR or PR
Overall survival	up to 3 years	Used for assessment of the efficacy.
Incidence of adverse events	up to 3 years	Graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Safety will be recorded through the incidence of adverse events, serious adverse events and specific laboratory abnormalities (worst grade) in each treatment arm.
Percentage of R0 resection	up to 8 months	Used for assessment of the feasibility of the neoadjuvant therapy.

Trial Locations

Locations (1)

Fudan University Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China