Actively Recruiting
Efficacy and Safety of Actinomycin-D With or Without Toripalimab as First-Line Treatment in Patients With Gestational Trophoblastic Neoplasia With FIGO Score 5-6: A Multicenter, Open-Label, Randomized Controlled Trial
Led by Peking Union Medical College Hospital · Updated on 2025-02-06
40
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
Researchers are evaluating whether combining toripalimab with actinomycin-D as a first-line treatment can improve the complete remission rate for patients with gestational trophoblastic neoplasia (GTN) who have a FIGO score of 5-6. The study also looks at whether multi-drug chemotherapy as a second-line treatment can achieve similar cure rates in patients who do not respond to the first-line combination therapy. This trial is a multicenter, open-label, randomized controlled study focused on the efficacy and safety of these treatments. Participants will be randomly assigned to one of two groups: the experimental group will receive toripalimab (200mg intravenously every two weeks) combined with actinomycin-D (1.25mg/m2, max 2mg, intravenously every two weeks), while the control group will receive actinomycin-D alone on the same schedule. Treatment continues until disease progression, unacceptable side effects, or withdrawal of consent, followed by three cycles of consolidation therapy after serum beta-hCG levels normalize. During the study, participants will undergo evaluations including serum beta-hCG monitoring, biomarker analysis, ovarian function tests, and quality of life assessments up to one year. Researchers will measure outcomes such as complete remission rate, objective response rate, progression-free survival, disease control, duration of response, overall survival, treatment safety, and patient quality of life. The total participation includes treatment and follow-up lasting up to one year with safety monitoring throughout.
CONDITIONS
Brief 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) including choriocarcinoma, invasive mole, or postmolar GTN with specified beta-hCG patterns
- FIGO score of 5-6
- Female aged 18 to 60 years
- No prior immunotherapy, chemotherapy, or radiotherapy
- Expected survival of at least 6 months
- ECOG performance status between 0 and 2 within 7 days before first dose
- Adequate organ function including hemoglobin ≥90 g/L, neutrophils ≥1.75×10⁹/L, platelets ≥100×10⁹/L, creatinine ≤1.75×ULN, urea nitrogen ≤2.75×ULN, total bilirubin ≤1.5×ULN, liver enzymes ≤2.75×ULN, coagulation parameters within specified limits, and normal thyroid function
You will not qualify if you...
- Histologically confirmed placental-site trophoblastic tumor or epithelioid trophoblastic tumor
- Primary choriocarcinoma confirmed by histology
- 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 stimulants within 6 weeks before treatment
- Previous immunotherapy including PD-1/PD-L1 inhibitors or other immune therapies
- Known allergy to actinomycin-D, toripalimab, or their components
- Active autoimmune disease requiring treatment in past 2 years
- History or current non-infectious pneumonia requiring steroids
- Use of steroids (>10 mg prednisone daily) or immunosuppressants within 14 days before enrollment
- Active infection needing systemic treatment
- HIV, active hepatitis B or C infection
- History of psychotropic drug abuse or mental disorders preventing withdrawal
- Significant heart conditions including recent myocardial infarction, heart failure, severe arrhythmia, or uncontrolled hypertension
- Abnormal blood clotting or bleeding disorders
- Recent cerebrovascular events or blood clots within 3 months
- Conditions affecting oral drug absorption such as swallowing difficulties or intestinal obstruction
- History of stem cell or organ transplantation
- Other conditions as judged by the investigator that may affect participation
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 - Up to 1 year or until treatment discontinuation
Participants receive actinomycin-D alone or actinomycin-D combined with toripalimab intravenously every 2 weeks. Treatment continues until completion, disease progression, unacceptable toxicity, or withdrawal of consent. After normalization of serum β-human chorionic gonadotropin (β-hCG) levels, participants receive 3 cycles of consolidation treatment.
Visits every 2 weeks for treatment administration
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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