Efficacy and Safety of Toripalimab Plus Actinomycin-D As Fist-Line Treatment in Patients with Gestational Trophoblastic Neoplasia with FIGO Score 7: a Single-Arm, Multicenter, Phase II Trial
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.
• Diagnosed as GTN:
• There is a histologic diagnosis of choriocarcinoma or invasive mole. Postmolar GTN: The plateau of β-hCG (±10%) lasts for four measurements over a period of 3 weeks or longer (days 1, 7, 14, 21). There is a rise (\>10%) in β-hCG for three consecutive weekly measurements over at least a period of 2 weeks or more (days 1, 7, 14).
• GTN after nonmolar pregnancy: There is a rise after decease, or a plateau of β-hCG 4 weeks after abortion, ectopic pregnancy, or term delivery. Pregnancy residue or new pregnancy have been ruled out.
• 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:
⁃ hemoglobin ≥90 g/L, absolute neutrophil count ≥1·5×109/L, platelets ≥100×109/L; creatinine ≤1·5 × upper limit of normal (ULN), urea nitrogen ≤2·5×ULN; total bilirubin ≤1.5×ULN, alanine aminotransferase and aspartate aminotransferase ≤2·5×ULN, INR, PT or APTT ≤1.5×ULN, thyroid stimulating hormone ≤ULN (if thyroid stimulating hormone is abnormal, normal T3 and T4 can also be acceptable).