A Single-arm, Phase II Study of Short-course Hypofractionated Radiotherapy Combined With Adebrelimab and Single-agent Platinum Chemotherapy as Neoadjuvant Therapy for Locally Advanced Cervical Cancer
Objective: This is a single-center, single-arm, Phase II clinical trial. The primary objective is to evaluate the pathological complete response (pCR) rate (defined as ypT0N0) following neoadjuvant therapy with short-course radiotherapy (SCRT) combined with Adebrelimab (an anti-PD-L1 monoclonal antibody) and single-agent platinum chemotherapy in patients with locally advanced cervical cancer (LACC). Study
Design: Patients will receive SCRT followed by three cycles of neoadjuvant chemoimmunotherapy. After completion of neoadjuvant treatment, radical hysterectomy with pelvic lymphadenectomy (with or without para-aortic lymphadenectomy) will be performed. Outcome Measures: Primary Endpoint: Pathological Complete Response (pCR) rate assessed by a central pathologist. Secondary Endpoints: Objective Response Rate (ORR) and R0 resection rate (per RECIST 1.1). Event-Free Survival (EFS) and 2-year EFS rate. Incidence and severity of Treatment-Related Adverse Events (TRAEs, per NCI-CTCAE v5.0) and surgical complications (per Clavien-Dindo classification). Feasibility and implementation rate of different adjuvant treatment strategies based on postoperative risk stratification. Depth of response (major pathological response, MPR). Inclusion Criteria: Key eligibility criteria include: Newly diagnosed, histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix. Clinical stage IB3-IIA2 or IIIA (without parametrial invasion) per FIGO 2018 staging. No evidence of extrapelvic lymph node metastasis or distant metastasis (confirmed by PET/CT or enhanced CT). Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Signed informed consent form prior to any study-specific procedure.
⁃ Female aged 18 to 80 years (inclusive) at the time of signing informed consent.
⁃ Histopathologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.
⁃ Clinical staging of IB3-IIA2, or IIIA without parametrial invasion (according to FIGO 2018 staging system); no pelvic lymph node metastasis confirmed by PET/CT, and no evidence of distant metastasis.
⁃ No prior surgery, radiotherapy, or systemic anti-tumor therapy for locally advanced cervical cancer (LACC).
⁃ At least one measurable lesion meeting RECIST 1.1 evaluation criteria.
⁃ ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1.
⁃ Adequate hematological, hepatic, and renal function within 14 days prior to enrollment (details to be confirmed in the full protocol).