NCT06036745招募中2 期
An Exploratory Single-Arm, Single-Center Study of Pembrolizumab in Combination With SOX Regimen for Adjuvant Treatment of Stage IIIB-IIIC Gastric Cancer
Shanghai Minimally Invasive Surgery Center1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年7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
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
it is an an Exploratory Single-Arm, Single-Center Study of Pembrolizumab in Combination with SOX Regimen for Adjuvant Treatment of Stage IIIB-IIIC Gastric Cancer
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
- •Subjects voluntarily join the study and sign an informed consent form;
- •Male or female patients between the ages of 18-75;
- •Adenocarcinoma of the gastric/esophagogastric junction after radical resection was staged at stage IIIB-IIIC;
- •The molecular pathology of gastric cancer must meet at least one of the following three conditions:
- •Consistent with high-frequency microsatellite instability MSI-H
- •Consistent with high tumor mutation load TMB-H (≥10 mutations/megabases)
- •High expression of PD-L1 (CPS score ≥5)
- •Expected survival time > 6 months；
- •ECOG (Eastern US Cooperative Oncology Group) score: 0-1 points;
- •Have not received anti-tumor immunotherapy;
- •Agree to provide archived tumor tissue samples for molecular testing;
- •Have good organ function:
- •Hemoglobin ≥90g/L;
- •Absolute neutrophil count ≥1.5×109/ L;
- •Platelet count ≥100×109/ L;
- •aspartate or alanine aminotransferase ≤ 2.5 times the upper limit;
- •alkaline phosphatase ≤ 2.5 times the upper normal limit ;
- •Women of reproductive age who need to use a medically approved contraceptive method (such as an IUD, contraceptive pill, or condom) during the study treatment period and for 3 months after the end of the study treatment period; For men who agreed to use an appropriate method of contraception during the trial and for 3 months after the last dose of the trial drug.
- •Women of reproductive age must be negative for serum or urine HCG within 72 hours prior to study entry. And must be non-lactating.
排除标准
- •Patients with severe hypertension and poor drug control;
- •Patients with difficulty in taking oral drugs due to dysphagia, complete or incomplete digestive tract obstruction, active gastrointestinal bleeding, perforation, etc.;
- •People who are known to be allergic to the ingredients in the test drug or have metabolic disorders;
- •Simultaneously participating in other tumor experimental drugs or being in other tumor clinical trials.
- •Severe liver disease (such as cirrhosis, etc.), kidney disease, respiratory disease or uncontrollable diabetes, hypertension and other chronic system diseases; Clinically obvious heart disease, such as congestive heart failure, obvious coronary heart disease, medically difficult to control arrhythmia, hypertension, or myocardial infarction within 6 months, or cardiac insufficiency;
- •Patients with peripheral nervous system disorders or a history of obvious mental disorders and central nervous system disorders;
- •Diagnosed with immunodeficiency or received systemic hormone therapy or other forms of immunosuppressive therapy within 7 days prior to initial administration;
- •Active period > CTCAE (Version 5.0) grade 2 clinical severe infection;
- •Pregnant and lactating women, women of childbearing age and their spouses refuse to take effective contraceptive methods;
- •Persons without legal capacity, whose medical or ethical reasons affect the continuation of the research.
- •Other conditions determined by the investigator to be unsuitable for inclusion in the study.
研究组 & 干预措施
Pembrolizumab + SOX
Experimental
干预措施: Pembrolizumab + SOX (Drug)
结局指标
主要结局
Disease-free survival
时间窗: 3 years
the time from the start of surgery to the incurable resection, local recurrence or metastasis, or death from any cause.
次要结局
- Overall survival(3 years)
- perioperative complications(the time from the start of enrollment to 3 months after surgery)
- Adverse Events(the time from the start of enrollment to 90 days after using drugs/ 30 days after surgery)
研究者
研究点 (1)
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