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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fecal microbiota transplantation | Procedure | Fecal microbiota transplantation (FMT) is the administration of a solution of fecal matter from a donor into the intestinal tract of a recipient in order to directly change the recipient's microbial composition and confer a health benefit |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | 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) | 5 years |
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Part 1: development of microbiome biomarkers
<Inclusion Criteria:> 1.Patients with pathologically confirmed solid cancer who are being treated with immunotherapy or are going to receive immunotherapy
<Exclusion Criteria>
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)
A history of active primary immunodeficiency
Active infection including tuberculosis or Human Immunodeficiency Virus (HIV)
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)
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)
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part 2: proof-of-concept trial on the fecal microbiota transplantation in patients who are being treated with immunotherapy for solid cancers
<Inclusion Criteria for donors>
<Inclusion criteria for recipients>
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sook Ryun Park, M.D, Ph D | Contact | +82-2-3010-3210 | srpark@amc.seoul.kr |
| Name | Affiliation | Role |
|---|---|---|
| Sook Ryun Park, M.D, Ph D | Asan Medical Center, Ulsan University of College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Recruiting | Seoul | Seoul | 05505 | South Korea |
IPD sharing is not planned.
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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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
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