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RECRUITING
NCT07286253
PHASE2

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

Sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University

View on ClinicalTrials.gov

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.

Official title: A Single-arm, Multicenter Phase II Clinical Study of QL1706 Plus Chemotherapy as Neoadjuvant Therapy for Locally Advanced Cervical Cance

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-10-28

Completion Date

2028-03-30

Last Updated

2025-12-16

Healthy Volunteers

No

Interventions

DRUG

Drug: Drug: QL1706 5mg/kg, iv drip,d1,Q3W;Albumin-Bound Paclitaxel 260mg/m2, iv drip, d1, Q3W;Cisplatin50mg/m2, iv drip, d1, Q3W;Carboplatin AUC 5 ivdrip, d1, Q3W

Drug: Drug: QL1706 5mg/kg, iv drip,d1,Q3W;Albumin-Bound Paclitaxel 260mg/m2, iv drip, d1, Q3W;Cisplatin50mg/m2, iv drip, d1, Q3W;Carboplatin AUC 5 ivdrip, d1, Q3W

Locations (1)

Lipai Chen

Guangzhou, Guangdong, China