NCT05833971尚未招募2 期
A Single-arm, Multicenter, Exploratory Study of Cadonilimab in Combination With Chemotherapy for Locally Advaced Esophageal Squamous Cell Carcinoma
Guangzhou Institute of Respiratory Disease0 个研究点目标入组 43 人开始时间: 2023年5月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 43
- 主要终点
- pathologic complete response (pCR)
研究概览
简要总结
This is a single-arm, multicenter, exploratory study to evaluate the efficacy and safety of AK104 in combination with cisplatin and paclitaxel in the treatment of resectable locally advanced esophageal squamous carcinoma.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years, both men and women
- •Pathologically confirmed esophageal squamous cell carcinoma，and the clinic staging is cT2N1-3M0 or cT3N0-3M0 or cT4N0-3M0, TNM staging is II-IVA
- •Non-cervical esophageal carcinoma
- •Patients who have never received systemic antitumor therapy and who have measurable lesions that meet RECIST 1.1 criteria
- •ECOG score 0-1
- •Life expectancy ≥12 months
- •Patients with normal function organs, no serious abnormalities of blood, heart, lung, liver, kidney function, and immunodeficiency disease
- •For female subjects of childbearing age, they should have a negative urine or serum pregnancy test within 7 days before receiving the first study drug administration. Male and female patients need to use high-efficiency contraception during treatment until at least 8 weeks after stop the treatment
- •Sign the informed consent form before any trial-related procedures are implemented
排除标准
- •-Other malignancies diagnosed within 5 years prior to the first administration of the study drug, except effectively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or effectively resected in situ cervical and/or breast cancer
- •ulcerative esophageal squamous cell carcinoma
- •Esophageal or tracheal fistula
- •History of allergy to study drug components
- •History of immune disease
- •Patients with any serious or uncontrolled systemic disease
- •The presence of any adverse event (CTCAE>grade 1) caused by prior therapy
研究组 & 干预措施
Experimental: cadonilimab (AK104) + chemotherapy
Experimental
Drug: Cadonilimab+ chemotherapy，10mg/kg IV every 3 weeks (Q3W)，Other Name: AK104； Cisplatin，60-75mg/m2 IV every 3 weeks (Q3W)，Other Name: DDP；Albumin Paclitaxel，260mg/m2 IV every 3 weeks D1, 8(Q3W)，Other Name: Nab-PTX
干预措施: cadonilimab+chemotherapy (Drug)
结局指标
主要结局
pathologic complete response (pCR)
时间窗: 1 month after resection
Analysis of prognosis efficacy of patients: pathologic complete response (pCR)
次要结局
- Objective response rate(ORR)(After the start of drugs and before resection)
- Disease control rate(DCR)(After the start of drugs and before resection)
- Disease-free survival(DFS)(After resection and up to 2 years)
- Radical resection (R0)(1 month after resection)
- Overall survival(OS)(up to 2 years)
研究者
Jun Liu
Professor
Guangzhou Institute of Respiratory Disease
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