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

Hepatocellular Carcinoma Clinical Trial

Official title:

A Phase Ib/II, Open-Label, Multi-Center Study Evaluating the Efficacy and Safety of Neoadjuvant Toripalimab Injection (JS001) or Toripalimab in Combination With Lenvatinib for Patients With Resectable Hepatocellular Carcinoma (HCC)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03867370
• Other study ID #: JS001-020-Ib-HCC
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: April 26, 2019
• Est. completion date: August 8, 2023

Study information

• Verified date: November 2023
• Source: Shanghai Junshi Bioscience Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: August 8, 2023
• Est. primary completion date: August 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Confirmed by histopathological or cytological examination; The criteria for resectability is met; Has at least one evaluable lesion according to the RECIST 1.1 standard and has not received local treatment;

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Toripalimab (JS001 )
Given IV
• Toripalimab (JS001 ) Lenvatinib
Given IV 4 mg capsules
• Toripalimab (JS001 ) Lenvatinib
Given IV 4 mg capsules

Locations

Country	Name	City	State
China	Fudan University Zhongshan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Junshi Bioscience Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological response rate	CPR,MPR	Up to 2 months
Secondary	Objective response rate	ORR is defined as the percentage of participants who achieved CR or PR	up to 2 months
Secondary	Percentage of R0 resection	Used for assessment of the feasibility of the neoadjuvant therapy.	up to 8 months
Secondary	Time to operation	Used for assessment of the feasibility of the neoadjuvant therapy.	up to 8 months
Secondary	Progression free survival	Used for assessment of the efficacy.	up to 3 years
Secondary	Overall survival	Used for assessment of the efficacy.	up to 3 years
Secondary	Incidence of adverse events	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.	up to 3 years