Chemoradiotherapy Combined With Serplulimab for Locally Advanced Cervical Cancer: A Prospective, Multicenter, Randomized, Phase II Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
This study is a randomized, controlled, open-label, phase II clinical trial designed to enroll patients with previously untreated locally advanced cervical cancer. The study aims to evaluate the efficacy and safety of adding chemotherapy to serplulimab combined with concurrent chemoradiotherapy. The primary endpoint of this study is progression-free survival (PFS).
详细描述
This study is a randomized, controlled, open-label, phase II clinical trial designed to evaluate the efficacy and safety of serplulimab in combination with chemotherapy and concurrent chemoradiotherapy in patients with locally advanced cervical cancer. Eligible patients are women aged 18-75 years with FIGO 2014 (International Federation of Gynecology and Obstetrics) stage IB2-IIB disease with lymph node positivity or stage III-IVA disease. Patients will be randomly assigned to two groups. Patients in the control group will receive serplulimab immunotherapy combined with concurrent chemoradiotherapy, followed by maintenance serplulimab for up to 2 years. Patients in the experimental group will receive, in addition to the above treatment, two cycles of induction chemotherapy and four cycles of consolidation chemotherapy, consisting of paclitaxel and platinum-based agents. The primary endpoint of this study is progression-free survival (PFS), which will be assessed by investigators according to RECIST version 1.1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Voluntarily willing to participate in the clinical study, fully informed about the study, and signed the informed consent form (ICF);
- •Willing and able to comply with all study procedures;
- •Female aged 18-75 years;
- •ECOG performance status of 0 or 1;
- •PD-L1 status not restricted;
- •Histologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma;
- •FIGO 2014 (International Federation of Gynecology and Obstetrics) stage IB2-IIB with positive lymph nodes, or stage III-IVA;
- •Patients must meet the following hematologic, renal, and hepatic function criteria:
- •Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L; Total bilirubin, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ 1.5 × upper limit of normal (ULN); Serum creatinine ≤ upper limit of normal (ULN); No prior anti-tumor treatment; Expected survival > 6 months;
- •Female subjects must have a negative serum pregnancy test within 14 days prior to study treatment, agree to use effective contraception during treatment and for 6 months after treatment, and breastfeeding is prohibited during the study.
排除标准
- •Histologically confirmed small cell cervical cancer;
- •Recurrent cervical cancer or presence of distant metastases;
- •Prior anti-tumor treatment;
- •Current or history of another active, untreated malignancy within the past 5 years, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ;
- •Any active or known autoimmune disease;
- •Active infection;
- •Requirement for systemic treatment with corticosteroids or other immunosuppressive agents within 14 days prior to randomization;
- •Arterial or venous thromboembolic events within 6 months prior to enrollment;
- •Uncontrolled clinically significant cardiac symptoms or disease;
- •Known allergy to the investigational drug or any of its excipients, or prior severe allergic reaction to other monoclonal antibodies;
- •Pregnant or breastfeeding women;
- •Neurological or psychiatric abnormalities affecting cognitive function;
- •Any other condition or situation that, in the investigator's judgment, would pose a serious risk to the subject's safety, potentially confound study results, or interfere with the subject's ability to complete the study.
研究组 & 干预措施
Experimental: chemotherapy combined with immunotherapy and radiotherapy
chemotherapy an Serplulimab plus chemoradiotherapy group
干预措施: Serplulimab (Drug)
Experimental: chemotherapy combined with immunotherapy and radiotherapy
chemotherapy an Serplulimab plus chemoradiotherapy group
干预措施: radiotherapy (Radiation)
Experimental: chemotherapy combined with immunotherapy and radiotherapy
chemotherapy an Serplulimab plus chemoradiotherapy group
干预措施: Chemotherapy (Drug)
Control group: immunotherapy and radiotherapy
Serplulimab plus chemoradiotherapy group
干预措施: Serplulimab (Drug)
Control group: immunotherapy and radiotherapy
Serplulimab plus chemoradiotherapy group
干预措施: radiotherapy (Radiation)
结局指标
主要结局
PFS
时间窗: through study completion, an average of 2 year
defined as the time from randomization to the first occurrence of disease progression or death from any cause.
OS
时间窗: through study completion, an average of 2 year
The time from random assignment to death because of any cause.
次要结局
- safety assessment(through study completion, an average of 2 year)