Utilization of Microbiome as Biomarkers and Therapeutics in Immuno-Oncology
ConditionSolid Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorAsan Medical Center
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- fecal microbiota transplantation
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov