Actively Recruiting
Toripalimab Plus Actinomycin-D as First-Line Treatment for Gestational Trophoblastic Neoplasia with FIGO Score 7 A Phase II Multicenter Trial Evaluating Efficacy and Safety
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
Researchers are evaluating the effectiveness and safety of combining toripalimab with actinomycin-D as a first-line treatment for women with gestational trophoblastic neoplasia (GTN) who have a FIGO score of 7. This Phase II clinical trial aims to determine if this combination can lead to a high complete remission rate and whether multi-drug chemotherapy can achieve similar cure rates as a second-line treatment if the initial treatment fails. Participants will receive toripalimab at 200 mg intravenously every two weeks along with actinomycin-D at 1.25 mg/m2 (maximum 2 mg) intravenously on the same schedule. Treatment continues until disease progression, unacceptable side effects, or withdrawal of consent, followed by four cycles of consolidation therapy after serum beta-human chorionic gonadotropin (β-hCG) levels normalize. Throughout the study, patients will be monitored for treatment response, including complete remission, progression-free survival, and overall survival. Researchers will also assess safety, biomarkers, ovarian function, and quality of life. Treatment duration varies based on individual response, with ongoing evaluations to track disease status and side effects.
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
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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
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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