Development of microbiome-based pharmabiotics
- Conditions
- Neoplasms
- Registration Number
- KCT0008049
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 500
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
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)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Response Rate
- Secondary Outcome Measures
Name Time Method Overall Response Rate