drugset / Trial / NCT06020755

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

EvaluationDrugModalityDoseRoute
Subject Dactinomycin Protein / enzyme biologic 1.25 mg/m2 Intravenous
Subject Toripalimab Monoclonal antibody 200 mg Intravenous