drugset / Trial / NCT06028672

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

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