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.
Signed informed consent form prior to any study-specific procedure.
Pregnant or lactating women, or women who intend to become pregnant during the study period and are unwilling to use effective contraception.
Single group
Adebrelimab
DrugAdebrelimab (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.
Pathological Complete Response (pCR) Rate
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