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NOT YET RECRUITING
NCT07613567
PHASE3

A Clinical Study of QL1706 Combined With Chemotherapy as Neoadjuvant Therapy for High-Risk Locally Advanced Cervical Cancer

Sponsor: Fujian Cancer Hospital

View on ClinicalTrials.gov

Summary

This study aims to compare the efficacy and safety of "neoadjuvant immunotherapy combined with chemotherapy followed by immunotherapy combined with radiotherapy during the radiotherapy period" versus "standard concurrent chemoradiotherapy" in locally advanced cervical cancer.

Official title: A Randomized, Multicenter, Phase III Study of Iparomlimab and Tuvonralimab (QL1706) Combined With Chemotherapy as Neoadjuvant Therapy for Locally Advanced Cervical Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

486

Start Date

2026-09-01

Completion Date

2032-08-31

Last Updated

2026-05-29

Healthy Volunteers

No

Interventions

RADIATION

standard EBRT+Brachytherapy

EBRT: 45-50.4Gy, Brachytherapy: 6Gy ×5

DRUG

Cisplatin

Cisplatin 40mg/m2, qw×5

DRUG

Neoadjuvant chemoimmunotherapy

Neoadjuvant phase: total of 2 cycles. Iparomlimab/Tuvonralimab 5mg/kg,D1,Q3W + albumin paclitaxel 90mg/m2, D1、8、15,Q3W+ Cisplatin 25mg/m2 or Carboplatin AUC = 1.5 , D1、8、15,Q3W

RADIATION

Radiotherapy combined with immunotherapy

Following neoadjuvant therapy, patients will receive EBRT + QL1706. After EBRT completion, brachytherapy dose is 600 cGy × 3 fractions for patients with clinical complete response (CCR), and 600 cGy × 5 fractions for non-CCR patients.

DRUG

Immunomaintenance therapy

Iparomlimab/Tuvonralimab (QL1706) 5 mg/kg,D1,Q3W. Will be administered for up to 2 years, until disease progression, or until unacceptable toxicity, whichever occurs first.

Locations (1)

Fujian Cancer Hospital

Fuzhou, Fujian, China