Evaluating the Efficacy and Safety of FMT Capsules XBI-302 Combined With Nivolumab in the Treatment of Anti-PD-1/L1 Resistant Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Disease control rate
研究概览
简要总结
This study is a single-arm, single center study. The purpose of this study is to evaluate the efficacy and safety of FMT capsules XBI-302 combined with Nivolumab in the treatment of anti-PD-1/L1 resistant gastric cancer.
详细描述
The primary purpose of this single-arm, open-label, single center trial is to evaluate the efficacy and safety of XBI-302 combined with Nivolumab in the treatment of anti-PD-1/L1 resistant gastric cancer.
During treatment period, all eligible subjects will receive XBI-302 with Nivolumab following gut preparation. The imaging evaluation of efficacy will be performed every 6 weeks.
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
- •Voluntarily participate in this study and provide written informed consent
- •Age ≥ 18 years and ≤70 years, male or female
- •Pathological confirmed locally advanced, unresectable or metastatic gastric adenocarcinoma, esophagogastric junction adenocarcinoma and lower esophagus adenocarcinoma that are resistant to anti-PD-1/L1 antibodies
- •Able and willing to provide tumor tissue
- •At least one measurable extracranial target lesion according to iRECIST
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •Life expectancy ≥3 months
排除标准
- •History of other primary malignancies within 5 years except adequately treated in situ carcinoma of the cervix or non-melanoma carcinoma of the skin
- •Had systemic diseases that were difficult to control within 4 weeks prior to screening
- •History of anti-PD-1 antibodies related adverse reactions that led to the permanent withdrawal of anti-PD-1 therapy
- •History of coagulation disorders
- •Mechanical or paralytic obstruction of the gastrointestinal tract
- •Anticipated to receive a great number of antibiotics during study period
研究组 & 干预措施
XBI-302 + Nivolumab
FMT capsules XBI-302 will be administered orally every two weeks for 12 weeks and then every four weeks for 12 weeks. Nivolumab will be intravenously infused every two weeks for 24 weeks.
干预措施: XBI-302 + Nivolumab (Drug)
结局指标
主要结局
Disease control rate
时间窗: 24 weeks
iCR + iPR + iSD rate according to iRECIST criteria
次要结局
- Disease control rate(6, 12, 18 weeks)
- Objective response rate(24 weeks)
- Changes of related immune cells in peripheral blood between responders and non-responders(12 weeks)
- Incidence and severity of AEs that related to XBI-302(24 weeks)
- Changes of intestinal microbiota characteristics between responders and non-responders(24 weeks)
- Change of CD8+T cell counts in tumor tissue between responders and non-responders(6 weeks)
- Incidence and severity of immune related AEs(24 weeks)
- Change of CD8+T cell counts in intestinal tissue between responders and non-responders(6 weeks)