Utilization of Microbiome as Biomarkers and Therapeutics in Immuno-Oncology

  • STATUS
    Recruiting
  • participants needed
    60
  • sponsor
    Asan Medical Center
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Updated on 16 February 2024
See if I qualify
cancer
colitis
prednisone
solid tumors
diarrhea
microbiota
hepatitis
tuberculosis
psoriasis
type 1 diabetes mellitus
hormone replacement therapy
fecal microbiota transplantation
vitiligo
intestinal disease
international travel
acute diverticulitis
gastrointestinal infection
solid carcinoma

Summary

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

Details
Condition Solid Carcinoma
Age 19years - 100years
Treatment fecal microbiota transplantation
Clinical Study IdentifierNCT04264975
SponsorAsan Medical Center
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

> 1.Patients with pathologically confirmed solid cancer
who are being treated with immunotherapy or are going to receive immunotherapy
Age 19 years old
Eastern Cooperative Oncology Group performance status 0-2
Measurable or evaluable lesion(s) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
<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)
#
\--------------------------------------------------------------------------------------
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>
Patients who have partial or complete response to immunotherapy at the time of stool donation
No history of exposure to HIV or hepatitis virus within the previous 12 months
No history of international travel within previous 6 months to areas of high risk of travelers' diarrhea
No current communicable disease
No household members with active gastrointestinal infection
No history of inflammatory bowel disease
No recent intake of potential allergenic foods that are known to cause hypersensitivity in a recipient (such as peanut)
<Inclusion criteria for recipients>
Patients without contraindications for colonoscopy such as suspected bowel perforation, acute diverticulitis, or fulminant colitis
Patients who have disease progression to immunotherapy as one of the following two
patterns
-1) Patients who have disease progression due to primary resistance to
immunotherapy
-2) Patients who have disease progression following disease stabilization due
to secondary resistance to immunotherapy
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cancer
colitis
prednisone
solid tumors
diarrhea
microbiota
hepatitis
tuberculosis
psoriasis
type 1 diabetes mellitus
hormone replacement therapy
fecal microbiota transplantation
vitiligo
intestinal disease
international travel
acute diverticulitis
gastrointestinal infection
solid carcinoma

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