Iparomlimab and Tuvonralimab (QL1706) for Intermediate Trophoblastic Tumors

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.

NCT Number	NCT06941766
Lead Sponsor	Peking Union Medical College Hospital Collaborators: Shengjing Hospital, Obstetrics & Gynecology Hospital of Fudan University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Henan Cancer Hospital, Gansu Provincial Maternal and Child Health Care Hospital, Dalian Women and Children's Medical Center, The First Affiliated Hospital of Xiamen University, Sichuan Cancer Hospital and Research Institute
Conditions	Intermediate Trophoblastic Tumor
Enrollment	20 participants
Start Date	2025-04-15
Primary Completion	2027-04-16 (estimated)
Study Completion	2028-04-16 (estimated)
Updated on ClinicalTrials.gov	2025-04-30