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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.
Details
| Lead sponsor | Peking Union Medical College Hospital |
|---|---|
| Phase | PHASE1, PHASE2 |
| Status | RECRUITING |
| Enrolment | 20 |
| Start date | Tue Apr 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Sun Apr 16 2028 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Intermediate Trophoblastic Tumor
Interventions
- QL1706
- Chemotherapy
Countries
China