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

Inclusion criteria

• 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);
• Histologically or cytologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma;
• Female patients aged ≥18 and ≤75 years;
• Willing and able to provide written informed consent and comply with study visits and protocol-required procedures;
• Eligible for radical hysterectomy with curative intent;
• At least one measurable lesion according to RECIST version 1.1;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
• Estimated life expectancy of at least 6 months;
• 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

• Histological subtypes other than squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma, including but not limited to small cell carcinoma and clear cell carcinoma.
• Clinically significant unrecoverable hydronephrosis;
• CNS metastases or leptomeningeal disease;
• Active malignancy within 3 years prior to enrollment (with specified exceptions);
• Prior exposure to immune checkpoint inhibitors or other immunomodulatory anticancer therapies;
• Major surgery within 4 weeks before study treatment;
• Severe cardiovascular or cerebrovascular disease;
• Unresolved toxicities from previous anticancer therapy (> Grade 1, CTCAE v5.0);
• Known hypersensitivity to study drugs;
• Serious medical or psychiatric conditions that may interfere with study participation;
• Pregnancy.