Actively Recruiting
Efficacy and Safety of Toripalimab Plus Actinomycin-D as First-Line Treatment in Patients with Gestational Trophoblastic Neoplasia with FIGO Score 7
Led by Peking Union Medical College Hospital · Updated on 2024-12-31
17
Participants Needed
1
Research Sites
N/A
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
This trial investigates the use of toripalimab combined with actinomycin-D as the first treatment for women diagnosed with gestational trophoblastic neoplasia (GTN) who have a FIGO score of 7. The main goal is to see if this combination can achieve a high rate of complete remission and to evaluate if patients who do not respond can be successfully treated with multi-drug chemotherapy as a second option. The study is a phase II, multicenter trial focused on safety and effectiveness in this specific patient group. Participants will receive toripalimab at a dose of 200mg intravenously every two weeks along with actinomycin-D at 1.25mg/m2 (up to 2mg maximum) intravenously every two weeks. Treatment continues until the disease progresses, unacceptable side effects occur, or consent is withdrawn. After serum beta-human chorionic gonadotropin (b2-hCG) levels normalize, patients will receive four cycles of consolidation treatment to complete the therapy. During the study, participants will have regular assessments including blood tests to monitor b2-hCG levels, organ function, and ovarian function, along with evaluations of quality of life and cancer-specific rehabilitation needs. Researchers will measure outcomes such as complete remission rate, objective response rate, progression-free survival, overall survival, duration of response, safety, and reproductive concerns. Follow-up and monitoring will occur up to one year after treatment to evaluate these outcomes.
CONDITIONS
Brief 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 confirmed by histology or specific beta-hCG measurement patterns
- FIGO score of 7
- Signed informed consent
- No prior immunotherapy, chemotherapy, or radiotherapy
- Female aged 18 to 60 years
- Expected survival of 6 months or more
- ECOG performance status of 0 to 2 within 7 days before first dose
- Adequate vital organ function as defined by specific blood counts and biochemical parameters
You will not qualify if you...
- Placental-site trophoblastic tumor or epithelioid trophoblastic tumor confirmed by histology
- Primary choriocarcinoma confirmed by histology
- Other cancers within the past 3 years
- Prior systemic anti-cancer treatments
- Live vaccines within 30 days before study drug
- Use of systemic immune stimulant agents within 6 weeks before treatment
- Previous immunotherapy including PD-1, PD-L1, or related drugs
- Known allergy to study drugs or their components
- Active autoimmune diseases requiring systemic treatment in past 2 years
- History or current non-infectious pneumonia requiring steroids
- Recent use of high-dose steroids or immunosuppressants
- Active infections requiring systemic treatment
- HIV, active hepatitis B or C infection
- History of psychotropic drug abuse or mental disorders
- Significant heart disease or uncontrolled hypertension
- Abnormal blood clotting or recent thrombotic events
- Conditions affecting drug absorption or recent organ perforation
- History of stem cell or organ transplantation
- Other reasons determined by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until completion of treatment or disease progression
Participants receive toripalimab and actinomycin-D intravenously every 2 weeks until completion of treatment, disease progression, unacceptable toxicity, or withdrawal of consent. After serum β-hCG levels normalize, participants will receive 4 cycles of consolidation treatment.
Infusions every 2 weeks with additional assessments as scheduled
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
Y
Yang Xiang
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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