Trials / Unknown
UnknownNCT03859128
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
- Status
- Unknown
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 402 (estimated)
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd. · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | TORIPALIMAB INJECTION(JS001 ) | Arm A: Toripalimab 240mg IV(Injection of Vein) Q3W Arm B: Placebo 240mg IV(Injection of Vein) Q3W |
Timeline
- Start date
- 2019-03-05
- Primary completion
- 2023-04-18
- Completion
- 2023-08-01
- First posted
- 2019-03-01
- Last updated
- 2023-03-31
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03859128. Inclusion in this directory is not an endorsement.