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Iparomlimab and Tuvonralimab (QL1706) for Intermediate Trophoblastic Tumors
Sponsor: Peking Union Medical College Hospital
Summary
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.
Official title: Efficacy and Safety of Iparomlimab and Tuvonralimab (QL1706) in the Treatment of Intermediate Trophoblastic Tumors: A Prospective, Multicenter, Single-arm Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-04-15
Completion Date
2028-04-16
Last Updated
2025-04-30
Healthy Volunteers
No
Conditions
Interventions
QL1706
5 mg/kg, IV infusion, Q3W (D1)
Chemotherapy
FAEV, EMA/EP, EMA/CO, or TP/TE.
Locations (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China