QL1706 Combined With Cisplatin/Paclitaxel as Neoadjuvant Therapy for Cervical Cancer

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.

NCT Number	NCT07617818
Lead Sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions	Cervical Cancer, Neoadjuvant Therapy, Immunotherapy
Enrollment	50 participants
Start Date	2026-06-15
Primary Completion	2028-06-15 (estimated)
Study Completion	2029-12-15 (estimated)
Updated on ClinicalTrials.gov	2026-06-01