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.