MedPath

Development of microbiome-based pharmabiotics

Not Applicable
Recruiting
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
Inclusion Criteria

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

Exclusion Criteria

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
NameTimeMethod
Overall Response Rate
Secondary Outcome Measures
NameTimeMethod
Overall Response Rate
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