NCT06346093招募中不适用
A Prospective, Randomised Placebo Controlled Trial of Faecal Microbiota Transplantation in Patients With Advanced Gastric Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Rate of Disease Control
研究概览
简要总结
This study is a randomized, double-blind and placebo-controlled study. The purpose of this study is to evaluate the efficacy and safety of FMT capsules combined with chemotherapy and anti-PD1/PDL1 therapy in the advanced gastric cancer.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（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 , male or female. Pathological confirmed locally advanced, unresectable or metastatic gastric adenocarcinoma, esophagogastric junction adenocarcinoma.
- •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
- •Life expectancy ≥3 months.
排除标准
- •Presence of absolute contra-indications to FMT administration:Toxic megacolon;Inflammatory bowel disease;Anatomic contra-indications to colonoscopy;Colectomy Patient is currently participating and receiving other study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of this study intervention.
- •Currently under any form of systemic antibiotics. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (> 10 mg prednisone daily or equivalent) or any other form of immunosuppressive therapy two weeks prior to trial treatment. Patients receiving systemic steroids at physiologic doses are permitted to enroll assuming steroid dose is not above the acceptable threshold (> 10 mg prednisone daily or equivalent).
- •Severe anaphylactic reaction to any food (food allergies). Had a severe hypersensitivity reaction to propofol. Has serious concomitant illnesses. The eligibility can be granted by the treating investigator on individual bases.
- •Has HIV infection or AIDS-related illness. Has active infection of HAV, HBV or HCV. Patients with a history of Hepatitis B/C infection who have received anti-viral therapy and are disease free may be considered for enrollment after discussion with Principal Investigator.
- •Patient has received a live vaccine within 4 weeks prior to the first dose of treatment. Seasonal influenza vaccines or COVID-19 vaccines for injection are generally inactivated virus vaccines and are allowed.
- •Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- •Females who are pregnant or breastfeeding. Active central nervous system (CNS) metastases and/or leptomeningeal involvement
结局指标
主要结局
Rate of Disease Control
时间窗: up to 6 months
Rate of Disease Control is defined as the percentage of subjects who had a complete response (CR), partial response (PR), or stable disease (SD), as defined by ir-RECIST v1.1.
Objective response rate (ORR)
时间窗: up to 6 months
ORR is defined as the percentage of subjects who had a complete response (CR) or partial response (PR), as defined by ir-RECIST v1.1, and is based on the best response obtained.
次要结局
- Progression-free Survival (PFS)(up to 2 years)
- Overall Survival (OS)(up to 2 years)
- Incidence of Adverse Events Related to Treatment(up to 6 months)
- Change in the intestinal microbiome community(up to 6 months)
- Quality of life based on the questionnaire(up to 2 years)
- Change in the immunity(up to 6 months)
研究者
Xiangyu Kong
Principle Investigator
Changhai Hospital
研究点 (1)
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