Toripalimab Plus Actinomycin-D As Fist-Line Treatment for GTN with FIGO Score 7
Summary
The goal of this clinical trial is to evaluate the efficacy and safety of toripalimab plus actinomycin-D as fist-line treatment in patients with gestational trophoblastic neoplasia with FIGO score 7. The main questions it aims to answer are: * Whether toripalimab plus actinomycin-D as fist-line treatment can achieve a high complete response rate. * Whether an equally high cure rate can be achieved by multi-drug chemotherapy as second-line treatment in patients who have failed fist-line treatment with toripalimab plus actinomycin-D. Participants will receive toripalimab plus actinomycin-D. Treatment will be continued until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment will be completed after 4 consolidation cycles.
Timeline
- Start
- 2024-12
- Primary completion
- 2025-08
- Completion
- 2025-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dactinomycin | Protein / enzyme biologic | 1.25 mg/m2 | Intravenous |
| Subject | Toripalimab | Monoclonal antibody | 200 mg | Intravenous |