Cadonilimab Plus Chemotherapy in LACC: A Prospective, Multicenter, Randomized Phase II Trial

This is a prospective, multi-center, randomized controlled phase II clinical trial aimed at exploring the efficacy evaluation of cadilonilumab immunotherapy combined with chemotherapy for locally advanced cervical cancer.

Inclusion Criteria: 1. Patients with previously untreated locally advanced cervical cancer, clinically staged as FIGO 2018 stage IB3, IIA2, IIB, or IIIC1r (tumor diameter \>4 cm as assessed by contrast-enhanced pelvic MRI); 2. Histologically or cytologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma; 3. Female patients aged ≥18 and ≤75 years; 4. Willing and able to provide written informed consent and comply with study visits and protocol-required procedures; 5. Eligible for radical hysterectomy with curative intent; 6. At least one measurable lesion according to RECIST version 1.1; 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 8. Estimated life expectancy of at least 6 months; 9. Women of childbearing potential must agree to use effective contraception throughout the study period. A negative serum or urine pregnancy test is required before study enrollment. Exclusion Criteria: 1. Histological subtypes other than squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma, including but not limited to small cell carcinoma and clear cell carcinoma. 2. Clinically significant unrecoverable hydronephrosis; 3. CNS metastases or leptomeningeal disease; 4. Active malignancy within 3 years prior to enrollment (with specified exceptions); 5. Prior exposure to immune checkpoint inhibitors or other immunomodulatory anticancer therapies; 6. Major surgery within 4 weeks before study treatment; 7. Severe cardiovascular or cerebrovascular disease; 8. Unresolved toxicities from previous anticancer therapy (\> Grade 1, CTCAE v5.0); 9. Known hypersensitivity to study drugs; 10. Serious medical or psychiatric conditions that may interfere with study participation; 11. Pregnancy.