Clinical Trial

QL1706 Plus Chemotherapy as Neoadjuvant Therapy for Locally Advanced Cervical Cancer: A Phase II Trial

Recruiting Phase 2
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Summary
Cervical cancer ranks as the second most common malignancy of the female genital tract. According to the World Health Organization, there are 530,000 new cases and approximately 250,000 cervical-cancer-related deaths worldwide each year, with 80% of these deaths occurring in women from developing countries. Early-stage disease can be managed surgically, whereas advanced or recurrent cervical cancer is treated with individualized multimodal therapy; nevertheless, the optimal management of locally advanced cervical cancer (FIGO 2018 stage IB3-IIA2) remains controversial. Chemoradiation is standard, but neoadjuvant chemotherapy followed by radical surgery after tumor down-staging is also used. More than 90% of cervical cancers are driven by persistent infection with high-risk human papillomavirus (HPV), which evades host immunity in part by up-regulating PD-L1 on tumor cells. Published series report PD-L1 positivity in 34.4-96% of cervical cancers, with even higher rates in squamous-cell histology, providing a rationale for PD-1/PD-L1 blockade. QL1706, a novel bispecific immunotherapeutic agent, has recently been approved as monotherapy for second-line treatment of advanced cervical cancer.QL1706, developed by Qilu Pharmaceutical using the proprietary MabPair™ platform, is the first bispecific antibody simultaneously targeting PD-1 and CTLA-4, showing synergistic anti-tumor activity and favorable tolerability.Unlike previous phase II/III trials of PD-1 monotherapy, this study does not restrict enrolment to patients with PD-L1-positive tumors, so QL1706 is expected to confer benefit in the second-line management of recurrent or metastatic cervical cancer. Therefore, investigating QL1706-based combination regimens as neoadjuvant treatment for treatment-naïve disease is also highly relevant and may improve outcomes in women with locally advanced cervical cancer.
Trial Details
NCT Number NCT07286253
Lead Sponsor Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Conditions Neoadjuvant Treatment for Locally Advanced Cervical Cancer
Enrollment 50 participants
Start Date 2025-10-28
Primary Completion 2027-09-30 (estimated)
Study Completion 2028-03-30 (estimated)
Updated on ClinicalTrials.gov 2025-12-16