Cadonilimab Combined With RT in LACC Patients Ineligible for CCRT

Inclusion criteria

• Female, age ≥18 years.
• Histologically confirmed cervical squamous cell carcinoma or adenosquamous carcinoma.
• FIGO 2018 stage IB3-IVA, or medically inoperable disease requiring definitive radiotherapy.
• ECOG performance status 0-2, life expectancy ≥6 months.
• 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.
• Adequate organ function:

• Total bilirubin ≤1.5 × ULN (≤3 × ULN for Gilbert's syndrome)
• AST and ALT ≤2.5 × ULN
• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion criteria

• Prior or concurrent invasive malignancy unless disease free for ≥5 years (exceptions: non melanoma skin cancer, cured in situ carcinoma).
• No histological confirmation of cervical cancer.
• Prior exposure to anti PD 1/PD L1, anti CTLA 4, or other immune checkpoint inhibitors.
• Congenital or acquired immunodeficiency (e.g., HIV infection).
• Active hepatitis B (HBsAg positive with detectable HBV DNA) or hepatitis C (HCV RNA positive).
• Pregnancy or lactation (negative serum/urine β hCG required for premenopausal women).
• 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)
• Psychiatric illness or social condition that would limit study compliance.
• Inability to understand the study purpose or refusal to sign informed consent.
• Any other condition that, in the investigator's judgment, makes the patient unsuitable for study participation.