Toripalimab or Placebo as Adjuvant Therapy in Hepatocellular Carcinoma After Radical Resection (JUPITER 04)

Shanghai Junshi Biosciences

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Biological: TORIPALIMAB INJECTION(JS001 )

Study type: Interventional

Funder types: Other

Identifiers

NCT03859128

JS001-016-III-HCC

Details and patient eligibility

About

This study will investigate if Toripalimab (A PD-1 Inhibitor) will improve recurrence-free survival (RFS) compared to placebo in participants with HCC and are at high risk of recurrence after complete resection with no residual of tumour.

Enrollment: 402 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

402 participants in 2 patient groups, including a placebo group

Group A

Active Comparator group

Description:

TORIPALIMAB 240mg ,Q3W, up to 16 cycles

Treatment:

Biological: TORIPALIMAB INJECTION(JS001 )

Group B

Placebo Comparator group

Description:

Placebo 240mg Q3W, up to 16 cycles

Treatment:

Biological: TORIPALIMAB INJECTION(JS001 )