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Development of microbiome-based pharmabiotics

Development of microbiome-based pharmabiotics to enhance the efficacy of immuno-oncology in refractory solid cancers

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0008049
Enrollment
500
Registered
2022-12-30
Start date
2018-06-15
Completion date
Unknown
Last updated
2023-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others(fecal microbiota transplantation) : Transplantation through colonoscopy - Enter the colonoscopy to the terminal endoscope and inject the stool suspension. Transplantation through non-intestinal

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
Overall Response Rate

Secondary

MeasureTime frame
Overall Response Rate

Countries

Korea, Republic of

Contacts

Public ContactWoo Ri Jo

Asan Medical Center

dotory5595@naver.com+82-2-3010-8463

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026