drugset / Trial / NCT07617818

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

NCT07617818

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

EvaluationDrugModalityDoseRoute
Subject Iparomlimab Monoclonal antibody
Subject Tuvonralimab Monoclonal antibody
Background Cisplatin Other / unclassified
Background Paclitaxel Small molecule

Indications