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.
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;
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);
Parallel
Neoadjuvant Therapy Plus Surgery
Procedure/SurgeryPatients received three cycles of neoadjuvant cadonilimab plus chemotherapy. Patients subsequently underwent radical hysterectomy with pelvic lymphadenectomy, with para-aortic lymph node biopsy/dissection performed when indicated. Postoperative adjuvant therapy was administered according to pathological findings.
Concurrent Chemoradiotherapy
Procedure/SurgeryPatients received standard concurrent chemoradiotherapy (CCRT), consisting of external beam radiotherapy combined with concurrent platinum-based chemotherapy.
2-year progression-free survival (PFS) rate
The proportion of patients who remain alive without radiologically confirmed disease progression at 2 years after randomization. Disease progression will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on imaging evaluations.
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This trial is not recruiting at the moment. You can still explore other options:
