NCT05561699尚未招募不适用
Sequential Preoperative Penpulimab Combined With Chemoradiotherapy(CRT) for Locally Advanced Esophageal Squamous Cell Cancer: A Prospective, Single Arm, Single Center，Exploratory Study
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2022年9月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- pathological complete remission（pCR）rate
研究概览
简要总结
This study used an open single center study design to observe the efficacy and safety of Penpulimab combined with Chemoradiotherapy(CRT) in preoperative T2,3,4aN0-1-2M0 esophageal squamous cell carcinoma (ESCC).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Resectable t2,3,4an0-1-2m0 esophageal squamous cell carcinoma initially diagnosed by histology or cytology;
- •Without any systematic anti-tumor treatment;
- •ECOG 0-1;
- •ANC≥ 1.5×109/L;
- •PLT≥ 75×109/L;
- •HB≥ 8.0 g/dL;
- •TBIL ≤ 1.5´ ULN;
- •ALT and AST ≤ 2.5´ULN;
- •Cr ≤ 1.5´ULN or CCr ≥ 60ml/min;
- •Urine protein < +, if urine protein + then the total protein in 24 hours must be <500mg;
- •Blood glucose is within the normal range and / or patients with diabetes are in treatment, but blood glucose is controlled in a stable state;
- •FEV1 ≥ 2L; If the baseline FEV1 is less than 2L, it is estimated that the FEV1 after surgery is greater than 800ml；
- •No myocardial infarction within 1 year; No unstable angina pectoris; No symptomatic severe arrhythmia; No cardiac insufficiency；
- •There are no serious complications or other major diseases that have not been cured；
- •Thoracic surgeons judge those who can tolerate the operation；
- •Female subjects with fertility and male subjects with partners of childbearing age need to use a medically approved contraceptive measure during the study treatment and at least 6 months after the last chemotherapy；
- •The subjects voluntarily joined the study and signed the informed consent form
排除标准
- •Received any kind of systematic anti-tumor treatment before the first use of the study drug；
- •At the same time, another clinical study will be included, unless it is an observational (non intervention) clinical study；
- •Subjects who need to be given corticosteroids (more than 10mg prednisone equivalent dose per day) or other immunosuppressants for systematic treatment within 2 weeks before the first use of the study drug；
- •Have been vaccinated with tumor vaccine or have been vaccinated with live vaccine within 4 weeks before administration；
- •Have a history of active autoimmune diseases and autoimmune diseases; Except for patients who have recovered from childhood asthma / allergy and do not need any intervention after adulthood; Autoimmune mediated hypothyroidism treated with a stable dose of thyroid hormone replacement; Use a stable dose of insulin for type I diabetes；
- •Serious interference occurred within 4 weeks before the first use of the study drug (CTC AE>2); Baseline chest imaging examination showed active pulmonary inflammation, symptoms and signs of infection within 2 weeks before the first use of the study drug, or the need for oral or intravenous antibiotics；
- •Have a history of interstitial lung disease；
- •The subjects had active hepatitis B (HBV DNA ≥ 2000 IU/ml or 104copies/ml), hepatitis C (hepatitis C antibody positive and HCV-RNA higher than the lower limit of the analysis method);
- •Pregnant or lactating women;
- •There are serious complications or other major diseases that have not been cured;
- •Patients judged by thoracic surgeons to be intolerant of surgery
研究组 & 干预措施
Penpulimab Combined With Chemoradiotherapy(CRT)
Experimental
干预措施: Penpulimab Combined With CRT (Drug)
结局指标
主要结局
pathological complete remission（pCR）rate
时间窗: 3 to 4 months
Proportion of subjects who achieved pathological complete remission (PCR)，PCR was defined as the microscopic absence of tumor cells in the pathological evaluation of excised esophageal cancer lesions and regional lymph node samples after surgery.
safety（AE or SAE）
时间窗: 2 to 3 years from baseline
Incidence of adverse events or serious adverse events
次要结局
- Tumor regression grade（TRG）(3 to 4 months)
- R0 resection rate(3 to 4 months)
- Event free survival（EFS）(2 to 3 years from baseline)
- Overall survival（OS）(2 to 3 years from baseline)
- Disease free survival（DFS）(2 to 3 years from baseline)
研究者
研究点 (1)
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