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

NCT07613567 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 486

Last updated 2026-05-29

No results posted yet for this study

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.

Conditions

  • Locally Advanced Cervical Carcinoma

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.

Sponsors & Collaborators

  • Fujian Cancer Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2032-08-31
Completion
2032-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07613567 on ClinicalTrials.gov