NCT03859128Active, not recruitingPhase 2/3
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 · Last updated 10 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 427 (actual)
- First submitted
- 18 Feb 2019
- Start date
- 5 Mar 2019
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT03859128
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 427
- From 5 Mar 2019 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- Portal vein tumor thrombi or liver metastases or recurrent liver cancer;
- With any history of active autoimmune disease or autoimmune disease;
- Known liver diseases with clinical significance;
- Patients infected by hepatitis B virus (HBV), hepatitis C virus (HCV), hepatitis D virus (HDV):
- Other protocol defined inclusion/exclusion criteria could apply
Other
- With symptoms of central nervous system metastasis;
Who the study is looking for
- HCC with at least one protocol defined risk factor, diagnosed confirmed by central pathological review and received R0 resection;
- BICR confirmed no resdual tumor lesions are detected in liver;
- Child-Puch score, Class A;
- ECOG score is 0;
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongshan Hospital,Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.