OncoMatch/Clinical Trials/NCT06020755
Toripalimab Plus Actinomycin-D As Fist-Line Treatment for GTN with FIGO Score 7
Is NCT06020755 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Toripalimab and Actinomycin-D for gestational trophoblastic neoplasia.
Treatment: Toripalimab · Actinomycin-D — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Disease stage
Required: Stage FIGO SCORE 7 (FIGO)
Patients with a FIGO score of 7.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: immunotherapy
No previous immunotherapy
Cannot have received: chemotherapy
No previous chemotherapy
Cannot have received: radiotherapy
No previous radiotherapy
Cannot have received: systemic anti-cancer treatment
Prior systemic anti-cancer treatment, including chemotherapy and radiotherapy
Lab requirements
Blood counts
hemoglobin ≥90 g/L, absolute neutrophil count ≥1·5×10^9/L, platelets ≥100×10^9/L
Kidney function
creatinine ≤1·5 × ULN, urea nitrogen ≤2·5×ULN
Liver function
total bilirubin ≤1.5×ULN, alanine aminotransferase and aspartate aminotransferase ≤2·5×ULN
Cardiac function
Grade II or higher myocardial ischemia, myocardial infarction or poorly controlled arrhythmia (females with QTc interval ≥470 ms); grade III to IV cardiac insufficiency according to NYHA criteria, or cardiac color Doppler ultrasound evidence of left ventricular ejection fraction <50%; myocardial infarction, NYHA grade II or above heart failure, uncontrolled angina, uncontrolled severe ventricular arrhythmia, clinically significant pericardial disease, or electrocardiogram suggesting acute ischemia or abnormal active conduction system occurring within 6 months before enrolment [excluded]
The function of vital organs meets the following requirements: hemoglobin ≥90 g/L, absolute neutrophil count ≥1·5×10^9/L, platelets ≥100×10^9/L; creatinine ≤1·5 × 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).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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