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Clinical Trial NCT07450963 for Locally Advanced Cervical Cancer is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Cadonilimab Combined With RT in LACC Patients Ineligible for CCRT Phase 2 45 Immunotherapy Open-Label Investigator-Initiated Overall Survival

Not yet recruiting
Clinical Trial NCT07450963 is designed to study Treatment for Locally Advanced Cervical Cancer. This Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on March 1, 2026 until the study accrues 45 participants. Led by Ruijin Hospital, this study is expected to complete by February 1, 2034. The latest data from ClinicalTrials.gov was last updated on March 5, 2026.
Brief 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 chemother...Show More
Official Title

Cadonilimab Combined With Radical Radiotherapy in Locally Advanced Cervical Cancer Patients Ineligible for Concurrent Chemotherapy - A Prospective, Single Arm, Phase II Trial

Conditions
Locally Advanced Cervical Cancer
Other Study IDs
  • 2026（56）
NCT ID Number
NCT07450963
Start Date (Actual)
2026-03
Last Update Posted
2026-03-05
Completion Date (Estimated)
2034-02
Enrollment (Estimated)
45
Study Type
Interventional
PHASE
Phase 2
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalCombined Treatment
Cadonilimab combined with Radical Radiotherapy
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.
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 l...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Complete response (CR) rate
The proportion of patients with disappearance of all target lesions (cervix and lymph nodes), no new lesions, and normalisation of tumour markers (e.g., SCC Ag), confirmed by pelvic MRI and/or PET CT and maintained for at least 4 weeks according to RECIST v1.1
5 year
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
2 year progression free survival
2 year
2 year local control rate
2 year
2 year locoregional control rate
2 year
5 year overall survival
5 year
Acute adverse events (AEs)
adverse events (AEs) according to CTCAE v5.0
up to 3 months
Late AE
RTOG/EORTC
up to 5 years
Quality of life assessed by EORTC QLQ C30 score
change from baseline in EORTC QLQ C30 score (0-100), higher scores mean a better outcome.
up to 5 years
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female

  1. Female, age ≥18 years.

  2. Histologically confirmed cervical squamous cell carcinoma or adenosquamous carcinoma.

  3. FIGO 2018 stage IB3-IVA, or medically inoperable disease requiring definitive radiotherapy.

  4. ECOG performance status 0-2, life expectancy ≥6 months.

  5. Presence of at least one absolute or relative contraindication to concurrent cisplatin based chemotherapy, defined as:

    • Age ≥70 years; OR
    • Renal impairment: serum creatinine >1.5 × upper limit of normal (ULN) or calculated creatinine clearance (CrCl) <50 mL/min (Cockcroft Gault); OR
    • Cardiac dysfunction: New York Heart Association class ≥II; OR
    • Prior allergic reaction to platinum agents; OR
    • Patient refusal of chemotherapy after thorough counselling.

  6. Adequate organ function:

    • Total bilirubin ≤1.5 × ULN (≤3 × ULN for Gilbert's syndrome)
    • AST and ALT ≤2.5 × ULN

  7. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

  1. Prior or concurrent invasive malignancy unless disease free for ≥5 years (exceptions: non melanoma skin cancer, cured in situ carcinoma).

  2. No histological confirmation of cervical cancer.

  3. Prior exposure to anti PD 1/PD L1, anti CTLA 4, or other immune checkpoint inhibitors.

  4. Congenital or acquired immunodeficiency (e.g., HIV infection).

  5. Active hepatitis B (HBsAg positive with detectable HBV DNA) or hepatitis C (HCV RNA positive).

  6. Pregnancy or lactation (negative serum/urine β hCG required for premenopausal women).

  7. Severe uncontrolled comorbidities precluding safe radiotherapy:

    • Unstable angina, myocardial infarction, or congestive heart failure requiring hospitalisation within 6 months
    • Acute bacterial or systemic fungal infection
    • Chronic obstructive pulmonary disease exacerbation requiring hospitalisation
    • Active connective tissue disease (e.g., systemic lupus erythematosus, scleroderma)

  8. Psychiatric illness or social condition that would limit study compliance.

  9. Inability to understand the study purpose or refusal to sign informed consent.

  10. Any other condition that, in the investigator's judgment, makes the patient unsuitable for study participation.

Ruijin Hospital logoRuijin Hospital
Study Responsible Party
Haoping Xu, Principal Investigator, Prof, Ruijin Hospital
No contact data.