Actively Recruiting
Iparomlimab and Tuvonralimab (QL1706) for Intermediate Trophoblastic Tumors
Led by Peking Union Medical College Hospital · Updated on 2025-04-30
20
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
P
Peking Union Medical College Hospital
Lead Sponsor
S
Shengjing Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This clinical trial aims to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab (QL1706), a dual-targeting immunotherapy (anti-PD-1/CTLA-4), in patients with intermediate trophoblastic tumors (ITT). The main questions it aims to answer are: Does QL1706 improve complete response (CR) rates (primary endpoint) and survival outcomes? What are the safety profiles of QL1706 in ITT, including immune-related adverse events? Participants will receive QL1706 (5 mg/kg IV, Q3W) ± chemotherapy (FAEV/EMA/EP/EMA/CO/TP-TE). They will also receive Maintenance therapy post-hCG normalization. Efficacy is assessed via serial β-hCG tests, imaging (every 9-12 weeks), and biomarker analysis.
CONDITIONS
Official Title
Iparomlimab and Tuvonralimab (QL1706) for Intermediate Trophoblastic Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged between 18 and 70 years
- Histologically confirmed placental site trophoblastic tumor (PSTT) or epitheloid trophoblastic tumor (ETT)
- Stage IV disease (treatment-na�ve, recurrent, or chemotherapy-resistant) or
- Stage I-III disease requiring adjuvant chemotherapy after biopsy or surgery with at least one risk factor: abnormal beta-hCG 2 weeks post-surgery, incomplete tumor resection, interval from last pregnancy 48 months, deep myometrial invasion, mitotic count >5/HPF, or tumor necrosis
- ECOG performance status score 0-1
- Signed informed consent
- Adequate organ function including hematologic, kidney, liver, and coagulation parameters as specified
You will not qualify if you...
- Life expectancy less than 3 months
- Non-gestational trophoblastic tumors
- Active malignancy unless cured more than 3 years prior
- Previous treatment with immune checkpoint inhibitors or cell-based immunotherapies
- Active autoimmune disease requiring systemic treatment within past 2 years (exceptions for hormone replacement and low-dose corticosteroids)
- Active inflammatory bowel disease like Crohn's disease or ulcerative colitis
- Systemic corticosteroid use over 10 mg/day prednisone equivalent within 14 days (topical/inhaled steroids allowed)
- HIV/AIDS infection
- Active hepatitis B or C without controlled viral load
- Active tuberculosis or severe uncontrolled infection
- Severe heart conditions such as NYHA Class III/IV heart failure or left ventricular ejection fraction below 50%
- Uncontrolled high blood pressure despite treatment
- Recent heart problems like unstable angina or arterial thrombosis within 6 months
- Interstitial lung disease or history of the condition
- Malabsorption syndromes or recent gastrointestinal perforation or fistula
- Psychiatric or social conditions limiting study compliance
- History of allogeneic transplant
- Live vaccine administration within 30 days before or planned during the study
- Known allergies to study drugs
- Pregnancy or breastfeeding
- Any other conditions that may compromise safety or study integrity
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
Yuan Li
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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