Toripalimab Plus Actinomycin-D As Fist-Line Treatment for GTN with FIGO Score 7 (NCT06020755) | Clinical Trial Compass
RecruitingPhase 2
Toripalimab Plus Actinomycin-D As Fist-Line Treatment for GTN with FIGO Score 7
China17 participantsStarted 2024-12
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Diagnosed as GTN:
✓. Patients with a FIGO score of 7.
✓. Signed informed consent.
✓. No previous immunotherapy, chemotherapy, or radiotherapy.
✓. Woman aged 18-60 years.
✓. Expected survival ≥ 6 months.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 7 days before first dose.
✓. The function of vital organs meets the following requirements:
✕. Prior systemic anti-cancer treatment, including chemotherapy and radiotherapy.
✕. Live vaccines injected within 30 days before the first dose of study drug;
✕. Systemic immune stimulant agent (such as a bacterial or viral vaccine, colony-stimulating factors, interferon, interleukin, and combined vaccine) was used 6 weeks before administration or within the 5 half-lives of the drug, whichever is shorter.
✕. Previous treatment with immunotherapy drugs (including antibodies targeting PD-1, PD-L1, PD-L2, cytotoxic T-lymphocyte-associated protein 4, T-cell receptor, chimeric antigen receptor T-cell therapy, and other immunotherapy).
✕. Known hypersensitivity or allergy to actinomycin-D, toripalimab or any of their excipients.