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Induction Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer

NCT06511726 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2026-06-04

No results posted yet for this study

Summary

This is an investigator-initiated, single-arm, phase II clinical study evaluating the efficacy and safety of cadonilimab combined with induction chemotherapy followed by concurrent chemoradiotherapy (CCRT) in patients with locally advanced cervical cancer (LACC). Despite standard concurrent chemoradiotherapy, patients with LACC remain at high risk of recurrence and distant metastasis. Cadonilimab, a PD-1/CTLA-4 bispecific antibody, has demonstrated promising antitumor activity in cervical cancer. This study aims to investigate whether induction immunochemotherapy with cadonilimab combined with cisplatin and albumin-bound paclitaxel can improve tumor response before definitive radiotherapy. In addition, the study will explore the association between treatment efficacy and dynamic changes in PD-L1 expression, peripheral blood immune-related biomarkers, and tumor microenvironment immune cell populations during treatment. The primary endpoint is objective response rate (ORR) assessed according to RECIST version 1.1, while secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.

Conditions

Interventions

DRUG

Cadonilimab

Cadonilimab will be administered intravenously in combination with cisplatin and albumin-bound paclitaxel as induction immunochemotherapy for 2 cycles.

DRUG

Cisplatin

Cisplatin will be administered during induction chemotherapy and weekly during concurrent chemoradiotherapy.

DRUG

Albumin-Bound Paclitaxel /nab-Paclitaxel

Albumin-bound paclitaxel will be administered intravenously in combination with cadonilimab and cisplatin during induction therapy.

RADIATION

Concurrent chemoradiotherapy

External beam radiotherapy will be delivered using 6-MV X-rays at a total dose of 45-60 Gy in 25 fractions, followed by brachytherapy at a dose of 30 Gy in 5 fractions. Weekly cisplatin (30-40 mg/m²) will be administered concurrently during radiotherapy.

Sponsors & Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Shoumin Bai · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-23
Primary Completion
2024-11-20
Completion
2029-04-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

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 NCT06511726 on ClinicalTrials.gov