drugset / Trial / NCT05139095
Camrelizumab Plus Apatinib in Patients With High-risk Gestational Trophoblastic Neoplasia
Phase 2
Recruiting
70 enrolled
Peking Union Medical College Hospital
Jiangsu HengRui Medicine Co., Ltd. · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the efficacy and safety of camrelizumab and apatinib as combination therapy in patients with ultra high-risk (Cohort A) and high-risk chemo-refractory or relapsed (Cohort B) gestational trophoblastic neoplasia (GTN). Eligible patients will receive camrelizumab plus apatinib plus chemotherapy. Treatment will be continued until disease progression, unacceptable toxicity, or withdrawal of consent.
Timeline
- Start
- 2022-01-27
- Primary completion
- 2026-12-01
- Completion
- 2027-01-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Camrelizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Rivoceranib | Small molecule | 250 mg | Oral |
| Background | Cisplatin | Other / unclassified | 20 mg/m2 | — |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Dactinomycin | Protein / enzyme biologic | 500 ug | — |
| Background | Etoposide | Small molecule | 100 mg/m2 | — |
| Background | Floxuridine | Unknown | — | — |
| Background | Methotrexate | Small molecule | — | — |
| Background | Vincristine | Small molecule | — | — |