Brief Summary A Phase II Single-Arm Clinical Trial of Short-Course Radiotherapy Combined with Adebrelimab and Platinum-Based Neoadjuvant Therapy for Locally Advanced Cervical Cancer Background \& 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Adebrelimab (1200 mg) is administered intravenously (IV) on Day 1 of each 21-day cycle (Q3W). Neoadjuvant Phase: Patients receive short-course radiotherapy (30 Gy in 6 fractions) concurrent with 2 cycles of Adebrelimab plus platinum-based chemotherapy (cisplatin or carboplatin). Adjuvant Phase: Following surgery, patients receive up to 3 additional cycles of Adebrelimab plus platinum. This is followed by maintenance therapy with Adebrelimab monotherapy (Q3W) for a total treatment duration of 1 year. High-risk patients (positive nodes/margins) may receive additional radiotherapy as clinically indicated.
The Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGPathological Complete Response (pCR) Rate
Time frame: At the time of definitive surgery (approximately 6-8 weeks after completion of neoadjuvant therapy).
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