KCT0008049招募中未知
Development of microbiome-based pharmabiotics to enhance the efficacy of immuno-oncology in refractory solid cancers
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •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
- •1. Patients who have partial or complete response to immunotherapy at the time of stool donation
- •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
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)
- •1. History of exposure to HIV or hepatitis virus within the previous 12 months
- •2. History of international travel within previous 6 months to areas of high risk of travelers' diarrhea
- •3. Current communicable disease
- •4. Household members with active gastrointestinal infection
- •5. History of inflammatory bowel disease
- •6. Recent intake of potential allergenic foods that are known to cause hypersensitivity in a recipient (such as peanut)
- •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)
研究者
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