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Cadonilimab Combined With RT in LACC Patients Ineligible for CCRT

NCT07450963 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-03-05

No results posted yet for this study

Summary

Concurrent chemoradiotherapy (CRT) is the standard of care for locally advanced cervical cancer (LACC). However, a substantial proportion of patients have contraindications to cisplatin based chemotherapy due to advanced age, renal impairment, cardiac dysfunction, or other comorbidities. For these patients, no evidence based standardised treatment exists. Immunotherapy combined with radiotherapy may offer a chemotherapy sparing alternative. Cadonilimab, a PD 1/CTLA 4 bispecific antibody, has demonstrated significant efficacy in advanced cervical cancer. This study aims to evaluate the efficacy and safety of cadonilimab combined with radical radiotherapy in LACC patients ineligible for concurrent chemotherapy.

This is an investigator initiated, prospective, single centre, single arm, open label, Simon's two stage phase II trial. A total of 45 patients will be enrolled. Eligible participants are women aged \>18 years with histologically confirmed cervical squamous cell carcinoma or adenosquamous carcinoma, FIGO 2018 stage IB3-IVA, and absolute or relative contraindications to cisplatin based chemotherapy. All patients will receive radical radiotherapy (external beam radiotherapy 45-50.4 Gy/25-28 fractions plus high dose rate brachytherapy 6-8 Gy × 3-5 fractions) concurrently with three cycles of cadonilimab 10 mg/kg intravenously every 3 weeks. The primary endpoint is complete response (CR) rate assessed at 4 weeks post radiotherapy. Secondary endpoints include 2 year progression free survival, 2 year local control, 2 year locoregional control, 5 year overall survival, safety (CTCAE v5.0 and RTOG late toxicity), and quality of life (EORTC QLQ C30 and QLQ BR23). Assuming a historical CR rate of 69% with radiotherapy alone, we hypothesise that the combination will increase CR to 85%. With α=0.05 (two sided) and 80% power, Simon's optimal two stage design requires 43 evaluable patients; after accounting for 5% dropout, 45 patients will be recruited.

Conditions

  • Locally Advanced Cervical Cancer

Interventions

DRUG

Cadonilimab

Cadonilimab will be administered as a 30-60 minute intravenous infusion at a dose of 10 mg/kg every 3 weeks for a total of 3 cycles. The first dose is scheduled within 3 days before or after the start of EBRT.

RADIATION

RT

External beam radiotherapy (EBRT): Intensity modulated radiotherapy (IMRT) or volumetric modulated arc therapy (VMAT) with daily image guidance. Total dose: 45-50.4 Gy in 25-28 fractions (1.8-2.0 Gy per fraction), 5 fractions per week. Target volumes include the gross tumour volume (cervix), entire uterus, parametria, and pelvic lymph node regions (including common iliac, presacral, and obturator nodes). Paraaortic lymph node regions are included if involved. Brachytherapy (BT): High dose rate (HDR) intracavitary/interstitial brachytherapy starting in the final week(s) of EBRT or immediately after. Dose: 6-8 Gy per fraction, 3-5 fractions, prescribed to the high risk clinical target volume (HR CTV). Total EQD2 (α/β=10) to point A and HR CTV D90 should exceed 80 Gy.

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2029-02-28
Completion
2034-02-28

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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 NCT07450963 on ClinicalTrials.gov