drugset / Trial / NCT07617818
QL1706 Combined With Cisplatin/Paclitaxel as Neoadjuvant Therapy for Cervical Cancer
Phase 2
Not yet recruiting
50 enrolled
Second Affiliated Hospital, School of Medicine, Zhejiang University
NaSingle-groupOpen-labelTreatment
Summary
This is a prospective, single-arm, phase II clinical study designed to evaluate the efficacy and safety of QL1706 combined with cisplatin and paclitaxel as neoadjuvant therapy in patients with FIGO 2018 stage IB1-IB3 cervical cancer undergoing conservative surgery. The primary endpoint is pathological complete response (pCR). Secondary endpoints include objective response rate (ORR), progression-free survival (PFS), overall survival (OS), 3-year pelvic recurrence rate, and safety profile. Additionally, exploratory biomarker analyses will be conducted to investigate changes in immune status, genomic alterations, PD-L1 expression, tumor mutational burden, MSI-H/dMMR status, and vaginal microbiota before and after treatment.
Timeline
- Start
- 2026-06-15
- Primary completion
- 2028-06-15
- Completion
- 2029-12-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Iparomlimab | Monoclonal antibody | — | — |
| Subject | Tuvonralimab | Monoclonal antibody | — | — |
| Background | Cisplatin | Other / unclassified | — | — |
| Background | Paclitaxel | Small molecule | — | — |