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

Shanghai Junshi Biosciences

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Hepatocellular Carcinoma

Treatments

Drug: Toripalimab (JS001 )

Drug: Toripalimab (JS001 ) Lenvatinib

Study type

Interventional

Funder types

Other

Identifiers

NCT03867370

JS001-020-Ib-HCC

Details and patient eligibility

About

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)

Enrollment

40 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

40 participants in 3 patient groups

Group A

Experimental group

Description:

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.

Treatment:

Drug: Toripalimab (JS001 )

Group B (Toripalimab, Lenvatinib)

Experimental group

Description:

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.

Treatment:

Drug: Toripalimab (JS001 ) Lenvatinib

Group C (Toripalimab, Lenvatinib)

Active Comparator group

Description:

Treatment:

Drug: Toripalimab (JS001 ) Lenvatinib