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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Pathological Complete Response (pCR) Rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •Adequate hematological, hepatic, and renal function within 14 days prior to enrollment (details to be confirmed in the full protocol).
排除标准
- •Pregnant or lactating women, or women who intend to become pregnant during the study period and are unwilling to use effective contraception.
- •Known hypersensitivity to adebrelimab, platinum-based drugs (cisplatin or carboplatin), or any component of the concomitant regimens.
- •History of other malignant tumors within 5 years prior to enrollment, except for cured non-melanoma skin cancer or cervical intraepithelial neoplasia.
- •Uncontrolled severe cardiovascular disease (e.g., NYHA Class III or IV heart failure, unstable angina pectoris, uncontrolled arrhythmias, or myocardial infarction within 6 months).
- •Active autoimmune disease requiring systemic immunosuppressive or corticosteroid therapy.
- •Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, or uncontrolled HIV infection.
- •Uncontrolled severe infection requiring systemic antibiotic/antiviral therapy at enrollment.
- •Prior participation in other clinical trials and received investigational drug within 4 weeks before enrollment.
- •Concomitant disease or condition that, in the judgment of the Investigator, would place the subject at undue risk or interfere with the subject's participation in the trial or interpretation of trial results.
结局指标
主要结局
Pathological Complete Response (pCR) Rate
时间窗: At the time of definitive surgery (approximately 6-8 weeks after completion of neoadjuvant therapy).
次要结局
未报告次要终点