drugset / Trial / NCT06028672
Toripalimab Plus Actinomycin-D as Fist-Line Treatment for GTN With FIGO Score 5-6
Recruiting
40 enrolled
Peking Union Medical College Hospital
Dalian Maternity and Child Care Hospital · collabGansu Provincial Maternal and Child Health Care Hospital · collabHenan Cancer Hospital · collabObstetrics & Gynecology Hospital of Fudan University · collabShanghai Junshi Bioscience Co., Ltd. · collabShengjing Hospital · collabSichuan Cancer Hospital and Research Institute · collabSun Yat-Sen Memorial Hospital of Sun Yat-Sen University · collabThe First Affiliated Hospital of Xiamen University · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Whether toripalimab plus actinomycin-D as fist-line treatment can achieve a higher complete response rate than actinomycin-D alone. 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 be allocated into two groups. Those in experimental group will receive toripalimab plus actinomycin-D, while those in control group will receive actinomycin-D alone. Treatment will be continued until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment will be completed after 3 consolidation cycles.
Timeline
- Start
- 2023-09-12
- 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 |