Actively Recruiting
Toripalimab Plus Actinomycin-D as Fist-Line Treatment for GTN With FIGO Score 5-6
Led by Peking Union Medical College Hospital · Updated on 2025-02-06
40
Participants Needed
1
Research Sites
98 weeks
Total Duration
On this page
Sponsors
P
Peking Union Medical College Hospital
Lead Sponsor
O
Obstetrics & Gynecology Hospital of Fudan University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Toripalimab Plus Actinomycin-D as Fist-Line Treatment for GTN With FIGO Score 5-6
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with gestational trophoblastic neoplasia (GTN) confirmed by histology or specific hormone patterns
- FIGO score of 5 to 6
- Female aged 18 to 60 years
- No prior immunotherapy, chemotherapy, or radiotherapy
- Expected survival of at least 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days before first dose
- Adequate vital organ function with specified blood counts and biochemical parameters
You will not qualify if you...
- Diagnosed with placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT)
- Histologically confirmed primary choriocarcinoma
- Other malignancies within the past 3 years
- Prior systemic anti-cancer treatments including chemotherapy or radiotherapy
- Recent live vaccines within 30 days before starting study drug
- Use of systemic immune stimulants within 6 weeks before or during study period
- Previous immunotherapy treatment
- Known allergies to study drugs or their components
- Active autoimmune disease requiring systemic treatment in past 2 years
- History or current non-infectious pneumonia needing steroids
- Use of steroids above 10mg/day prednisone or other immunosuppressants within 14 days before enrollment
- Active infections requiring systemic treatment
- HIV/AIDS or active hepatitis B or C infections
- History of psychotropic drug abuse or mental disorders preventing withdrawal
- Significant heart conditions including recent myocardial infarction, severe arrhythmia, or heart failure
- Uncontrolled hypertension despite optimal treatment
- Abnormal coagulation with bleeding risk or on blood thinners
- Recent cerebrovascular events or thrombotic conditions within 3 months
- Gastrointestinal issues affecting drug absorption
- History of stem cell or organ transplantation
- Other conditions as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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