Toripalimab or Placebo as Adjuvant Therapy in Hepatocellular Carcinoma After Radical Resection

Official record

Identifier

NCT03859128

Recruiting locations

country

China

Interventions studied

TORIPALIMAB INJECTION(JS001 )

Lead sponsor

Shanghai Junshi Bioscience Co., Ltd.

Target enrolment

427 participants

Study type

INTERVENTIONAL

Phase

Phase 2/3

Status

Active, not recruiting

First posted

Mar 1, 2019

Last updated on the registry

Aug 10, 2026

Age

18 Years – 75 Years

Sex

ALL

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria:

1. HCC with at least one protocol defined risk factor, diagnosed confirmed by central pathological review and received R0 resection;
2. BICR confirmed no resdual tumor lesions are detected in liver;
3. Child-Puch score, Class A;
4. ECOG score is 0;

Exclusion Criteria:

1. Patients previously received PD-1 antibody, PD-L1 antibody, PD-L2 antibody or CTLA-4 antibodies, including those who have participated in the JS001 clinical study;
2. Portal vein tumor thrombi or liver metastases or recurrent liver cancer;
3. With symptoms of central nervous system metastasis;
4. With any history of active autoimmune disease or autoimmune disease;
5. Known liver diseases with clinical significance;
6. Patients infected by hepatitis B virus (HBV), hepatitis C virus (HCV), hepatitis D virus (HDV):

Other protocol defined inclusion/exclusion criteria could apply

Indexed under

Liver Cancer