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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

fecal microbiota transplantation
Procedure/Surgery
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

Treatment groups

60 Participants

are divided into 1 treatment group

Group A: Fecal microbiota transplantationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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)

Time frame

5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Asan Medical Center

Lead sponsor

Source ClinicalTrials.gov

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