Actively Recruiting
Toripalimab Plus Actinomycin-D As Fist-Line Treatment for GTN with FIGO Score 7
Led by Peking Union Medical College Hospital · Updated on 2024-12-31
17
Participants Needed
1
Research Sites
34 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
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.
CONDITIONS
Official Title
Toripalimab Plus Actinomycin-D As Fist-Line Treatment for GTN with FIGO Score 7
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with gestational trophoblastic neoplasia (GTN) including choriocarcinoma or invasive mole, or postmolar GTN with specific β-hCG measurement patterns
- FIGO score of 7
- Signed informed consent
- No previous immunotherapy, chemotherapy, or radiotherapy
- Female aged 18 to 60 years
- Expected survival of at least 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 7 days before first dose
- Vital organ function meeting specified blood counts, kidney, liver, coagulation, and thyroid hormone levels
You will not qualify if you...
- Histologically confirmed 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 treatment including chemotherapy and radiotherapy
- Live vaccines within 30 days before first dose
- Use of systemic immune stimulant agents within 6 weeks before treatment
- Previous immunotherapy treatment
- Known allergy to actinomycin-D, toripalimab, or their ingredients
- Active autoimmune disease requiring treatment in past 2 years
- History or current non-infectious pneumonia needing steroids
- Use of steroid hormones >10 mg/day prednisone or other immunosuppressants within 14 days before enrollment
- Active infection needing systemic treatment
- HIV infection, AIDS, active hepatitis B or C
- History of psychotropic drug abuse or mental disorders
- Significant heart conditions including myocardial ischemia, infarction, heart failure, or arrhythmia
- Uncontrolled high blood pressure despite treatment
- Abnormal blood clotting with bleeding risk or anticoagulant therapy
- Recent history (within 3 months) of stroke, thrombosis, or embolism
- Conditions affecting oral drug absorption or recent intestinal surgery
- 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
Research Team
Y
Yang Xiang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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