NCT04264975招募中不适用
Utilization of Microbiome as Biomarkers and Therapeutics in Immuno-Oncology
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Overall Response Rate
研究概览
简要总结
This is an open label, single-center, non-randomized clinical trial on utilization of microbiome as biomarkers and therapeutics in immuno-oncology.
This research consists of two parts:
part 1: development of microbiome biomarkers for immuno-oncology part 2: proof-of-concept trial on the fecal microbiota transplantation in patients who are being treated with immunotherapy for advanced solid tumor
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Part 1: development of microbiome biomarkers
- •\ 1.Patients with pathologically confirmed solid cancer who are being treated with immunotherapy or are going to receive immunotherapy
- •1. Age ≥ 19 years old
- •2. Eastern Cooperative Oncology Group performance status 0-2
- •3. Measurable or evaluable lesion(s) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
排除标准
- •1. A history of other cancers requiring treatment within the recent 3 years (excepting treated basal or squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, breast, or stomach)
- •2. A history of active primary immunodeficiency
- •3. Active infection including tuberculosis or Human Immunodeficiency Virus (HIV)
- •4. Autoimmune disease (excepting type 1 diabetes mellitus, hypothyroidism requiring hormone replacement therapy only, skin disease not requiring systemic therapy (such as vitiligo, psoriasis or alopecia)
- •5. Patients who are receiving immunosuppressive medications (excepting topical steroids, systemic steroid ≤10 mg/day prednisone or equivalents, or a brief course of steroids for prophylaxis (e.g., hypersensitivity reaction)
- •\--------------------------------------------------------------------------------------------
- •part 2: proof-of-concept trial on the fecal microbiota transplantation in patients who are being treated with immunotherapy for solid cancers
- •\ 1. Patients who have partial or complete response to immunotherapy at the time of stool donation
- •2. No history of exposure to HIV or hepatitis virus within the previous 12 months
- •3. No history of international travel within previous 6 months to areas of high risk of travelers' diarrhea
- •4. No current communicable disease
- •5. No household members with active gastrointestinal infection
- •6. No history of inflammatory bowel disease
- •7. No recent intake of potential allergenic foods that are known to cause hypersensitivity in a recipient (such as peanut)
- •\ 1. Patients without contraindications for colonoscopy such as suspected bowel perforation, acute diverticulitis, or fulminant colitis
- •2. Patients who have disease progression to immunotherapy as one of the following two patterns:
- •2-1) Patients who have disease progression due to primary resistance to immunotherapy
- •2-2) Patients who have disease progression following disease stabilization due to secondary resistance to immunotherapy
研究组 & 干预措施
Fecal microbiota transplantation
Experimental
Fecal microbiota transplantation in patients who have advanced solid cancer with primary (group 1) or secondary resistance (group 2) to immuno-oncology
干预措施: fecal microbiota transplantation (Procedure)
结局指标
主要结局
Overall Response Rate
时间窗: 5 years
the proportion of patients who have a partial or complete response to therapy per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1 or immune RECIST(iRECIST)
次要结局
未报告次要终点
研究者
Sook Ryun Park
Associate Professor
Asan Medical Center
研究点 (2)
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