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Solid CarcinomaNCT04264975

Utilization of Microbiome as Biomarkers and Therapeutics in Immuno-Oncology

A study testing fecal microbiota transplantation in people with Solid Carcinoma, run by Asan Medical Center at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Solid Carcinoma
What is being tested?
fecal microbiota transplantation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSouth Korea
Study dates
4 Jun 2018to 31 Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

  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

<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) -------------------------------------------------------------------------------------------- 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>

  1. Patients who have partial or complete response to immunotherapy at the time of stool donation
  2. No history of exposure to HIV or hepatitis virus within the previous 12 months
  3. No history of international travel within previous 6 months to areas of high risk of travelers' diarrhea
  4. No current communicable disease
  5. No household members with active gastrointestinal infection
  6. No history of inflammatory bowel disease
  7. No recent intake of potential allergenic foods that are known to cause hypersensitivity in a recipient (such as peanut)

<Inclusion criteria for recipients>

  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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sook Ryun Park, M.D, Ph D contact

+82-2-3010-3210

srpark@amc.seoul.kr

South Korea1 site, 1 recruiting

  • Asan Medical Center

    Seoul, Seoul, 05505

    Sook Ryun Park, M.D, Ph D, +82-2-3010-3206, srpark@amc.seoul.kr

    Recruiting

Other trials in South Korea

About this study

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

Conditions
Solid Carcinoma
Being tested
fecal microbiota transplantation
Keywords
immuno-oncology, immunotherapy, biomarker, fecal microbiota transplantation (FMT), microbiome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fecal microbiota transplantationProcedure or surgery

    Also called FMT

    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

Study groups in NCT04264975
Study groupRoleWhat they receive
Fecal microbiota transplantationExperimentalFecal microbiota transplantation in patients who have advanced solid cancer with primary (group 1) or secondary resistance (group 2) to immuno-oncology
Receives: Procedure: fecal microbiota transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2020
  2. Study start4 Jun 2018
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04264975
Sponsor's protocol ID
2018-0608
Status last verified
May 2026
First submitted
2 Jan 2020
Last updated
22 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD sharing is not planned.

Publications

  • Kim Y, Kim G, Kim S, Cho B, Kim SY, Do EJ, Bae DJ, Kim S, Kweon MN, Song JS, Park SH, Hwang SW, Kim MN, Kim Y, Min K, Kim SH, Adams MD, Lee C, Park H, Park SR. Fecal microbiota transplantation improves anti-PD-1 inhibitor efficacy in unresectable or metastatic solid cancers refractory to anti-PD-1 inhibitor. Cell Host Microbe. 2024 Aug 14;32(8):1380-1393.e9. doi: 10.1016/j.chom.2024.06.010. Epub 2024 Jul 25.

    PubMed 39059396

Questions about this trial

What is this clinical trial studying?

A study testing fecal microbiota transplantation in people with Solid Carcinoma, run by Asan Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sook Ryun Park, M.D, Ph D (+82-2-3010-3210, srpark@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04264975, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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