drugset / Trial / NCT04233840
P1101 and Anti-PD1 for After Curative Surgery of Hepatitis B-related Hepatocellular Carcinoma
RandomizedParallel-groupOpen-labelTreatment
Summary
The main purpose of this trial is to evaluate the safety of the new adjuvant treatment of curative HCC, or the treatment of long-acting interferon P1101 alone, or the use of long-acting interferon P1101 and subsequent treatment of anti-PD1, and any efficacy in reducing the recurrence rate of patients after surgery.
Timeline
- Start
- 2019-02-12
- Primary completion
- 2022-12-31
- Completion
- 2023-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nivolumab | Monoclonal antibody | 0.3 mg/kg | — |
| Subject | Nivolumab | Monoclonal antibody | 0.75 mg/kg | — |
| Subject | Nivolumab | Monoclonal antibody | 1.5 mg/kg | — |
| Subject | Nivolumab | Monoclonal antibody | 3 mg/kg | — |
| Subject | Ropeginterferon alfa-2b | Protein / enzyme biologic | 450 ug | Subcutaneous |