NCT07168200招募中3 期
A Randomized, Controlled, Double-blind, Multicenter Phase III Clinical Study of Adebrelimab Combined With Concurrent Chemoradiotherapy Versus Placebo Combined With Concurrent Chemoradiotherapy for the Treatment of Locally Advanced Cervical Cancer
Shanghai Shengdi Pharmaceutical Co., Ltd1 个研究点 分布在 1 个国家目标入组 720 人开始时间: 2025年10月17日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 720
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
This study aims to evaluate the efficacy of Adebrelimab plus concurrent chemoradiotherapy compared with placebo plus concurrent chemoradiotherapy for the treatment of locally advanced cervical cancer by evaluating progression-free survival (PFS).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Participate in the study voluntarily, sign the informed consent form.
- •Subjects were able to provide primary or metastatic cancer samples.
- •At least one measurable lesion.
- •Expected survival > 3 months.
- •With adequate organ functions.
排除标准
- •Pathologically or radiologically confirmed presence of distant metastatic disease, including lymph nodes above the first lumbar vertebra (L1) (cephalad) or in the inguinal region.
- •Administering live vaccines within 4 weeks before enrollment or during planned study treatment.
- •Participants who received immunosuppressive therapy within 4 weeks before enrolment.
- •For participants who are receiving thrombolytic/anticoagulant therapy, prophylactic anticoagulant therapy is allowed.
- •Participants who have had other uncured malignant tumors in the past (within 5 years) or concurrently have had other uncured malignant tumors, excluding cured basal cell carcinoma of the skin and carcinoma in situ.
- •Known allergy to the investigational drug or any of its excipients; or severe allergic reaction to other monoclonal antibodies.
- •Pregnant or breastfeeding women.
- •According to the investigator's judgment, there are diseases or any other conditions that may seriously endanger the safety of the subjects, may confound the research results, or affect the subjects' ability to complete the study.
研究组 & 干预措施
SHR-1316 Group
Experimental
干预措施: SHR-1316 Injection (Drug)
SHR-1316 Group
Experimental
干预措施: Carboplatin Injection (Drug)
SHR-1316 Group
Experimental
干预措施: Paclitaxel Injection (Drug)
SHR-1316 Placebo Group
Placebo Comparator
干预措施: Cisplatin Injection (Drug)
SHR-1316 Placebo Group
Placebo Comparator
干预措施: Carboplatin Injection (Drug)
SHR-1316 Placebo Group
Placebo Comparator
干预措施: Paclitaxel Injection (Drug)
SHR-1316 Placebo Group
Placebo Comparator
干预措施: SHR-1316 Placebo Injection (Drug)
SHR-1316 Group
Experimental
干预措施: Cisplatin Injection (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: Up to approximately 36 months.
次要结局
- Local recurrence rate(Up to approximately 36 months.)
- Distant metastasis rate(Up to approximately 60 months.)
- 2-year progression-free survival (PFS)(Up to approximately 24 months.)
- Overall survival (OS)(Up to approximately 60 months.)
- 3-year overall survival (OS) rate(Up to approximately 60 months.)
- Objective Response Rate (ORR)(Up to approximately 36 months.)
- Duration of response (DoR)(Up to approximately 60 months.)
- Local progression rate(Up to approximately 36 months.)
- Distant recurrence rate(Up to approximately 60 months.)
- The second disease progression assessed by the investigator(Up to approximately 60 months.)
- Adverse events (AEs) including incidence and grade correlation with study drugs(Up to approximately 60 months.)
- Rate of suspension and discontinuation due to an adverse event correlation with study drugs(Up to approximately 60 months.)
研究者
研究点 (1)
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