Clinical trial · Interventional
Toripalimab or Placebo as Adjuvant Therapy in Hepatocellular Carcinoma After Radical Resection
A Phase II/III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Toripalimab (Recombinant Humanized Anti-PD-1 Monoclonal Antibody, JS001) Versus Placebo as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence Following Radical Resection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TORIPALIMAB INJECTION(JS001 ) | Biological | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group A
- description
- TORIPALIMAB 240mg ,Q3W, up to 16 cycles
- interventionNames
- Biological: TORIPALIMAB INJECTION(JS001 )
- type
- PLACEBO_COMPARATOR
- label
- Group B
- description
- Placebo 240mg Q3W, up to 16 cycles
- interventionNames
- Biological: TORIPALIMAB INJECTION(JS001 )
Primary outcomes (1)
- measure
- BICR-RFS
- timeFrame
- Time frame is up to 100 months (for interim analysis, up to 92 months for Primary analysis)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available