Colorectal Cancer MetastaticEarly Phase 1NCT07486492
Using Healthy Gut Bacteria to Boost Immune Treatment for Advanced Bowel Cancer
A Early Phase 1 study testing yFMT in people with Colorectal Cancer Metastatic and Fecal Microbiota Transplantation, run by The First Affiliated Hospital of Xiamen University.
Trial summary
This research protocol outlines an exploratory study on the combination of early-life fecal microbiota transplantation (yFMT) with immunotherapy and chemotherapy in patients with microsatellite stable metastatic colorectal cancer (MSS mCRC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer Metastatic, Fecal Microbiota Transplantation
- What is being tested?
- yFMT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2026to 31 Jan 2028
- Phase
- Early Phase 1
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed diagnosis of MSS mCRC
- Experienced disease progression after first-line chemotherapy and targeted therapy
- ECOG performance status of 0-1
Who cannot join
- History of FMT
- Severe organ dysfunction (heart, lung, liver, kidney)
- Other malignancies, psychiatric disorders, pregnancy or lactation
- Unable to provide informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Exploratory Study of Fecal Microbiota Transplantation (FMT) Combined With Immunotherapy and Chemotherapy in Microsatellite Stable Metastatic Colorectal Cancer (MSS mCRC)
This research protocol outlines an exploratory study on the combination of early-life fecal microbiota transplantation (yFMT) with immunotherapy and chemotherapy in patients with microsatellite stable metastatic colorectal cancer (MSS mCRC). The single-center, single-arm study aims to assess the safety of yFMT in conjunction with immunotherapy and chemotherapy, with a secondary focus on exploring its efficacy and impact on the patients' immune microenvironment. The study will enroll 10 patients aged 18-75 who have progressed after first-line chemotherapy and targeted therapy. The intervention involves six sessions of yFMT every two weeks, alongside PD-1 inhibitor immunotherapy and FOLFIRI chemotherapy. The primary endpoints are the incidence of serious adverse events (SAEs), treatment-related adverse events (TRAEs), and intervention adjustments due to adverse events, while secondary endpoints include progression-free survival (PFS), objective response rate (ORR), and overall survival (OS). The study is expected to last two years from initiation to data analysis completion, and it will be conducted at the Gastrointestinal Tumor Surgery Department of the First Affiliated Hospital of Xiamen University.
Read the detailed description
The research protocol for the study titled "Exploratory Study of Early Life Fecal Microbiota Transplantation (yFMT) Combined with Immunotherapy and Chemotherapy in Microsatellite Stable Metastatic Colorectal Cancer (MSS mCRC)" is designed to investigate a novel treatment approach for patients with MSS mCRC, a group that typically does not respond well to immunotherapy. The study is being conducted at the Gastrointestinal Tumor Surgery Department of the First Affiliated Hospital of Xiamen University.
Objectives:
Primary Objective: To evaluate the safety of combining yFMT with immunotherapy (PD-1 inhibitor) and chemotherapy (FOLFIRI) in patients with MSS mCRC.
Secondary Objectives: To explore the efficacy of the combined treatment in terms of progression-free survival (PFS), objective response rate (ORR), and overall survival (OS), as well as to assess the impact of yFMT on the patients' immune microenvironment and its potential synergistic effects with immunotherapy and chemotherapy.
Study Design:
The study is a single-center, single-arm trial with a total of 10 participants. The study timeline includes a screening period of 2 weeks, a treatment period of 3 months, and a follow-up period of 9 months.
Participants:
The study will enroll 10 patients aged between 18 and 75 years, regardless of gender.
Inclusion Criteria: Patients must have a confirmed diagnosis of MSS mCRC, must have experienced disease progression after first-line chemotherapy and targeted therapy, and must have an ECOG performance status of 0-1.
Exclusion Criteria: Patients with a history of FMT, severe organ dysfunction (heart, lung, liver, kidney), other malignancies, psychiatric disorders, pregnancy or lactation, and those unable to provide informed consent will be excluded.
Interventions:
Participants will receive yFMT every two weeks for a total of six sessions, along with PD-1 inhibitor immunotherapy and FOLFIRI chemotherapy.
Endpoints:
Primary Endpoints: The incidence of serious adverse events (SAEs), treatment-related adverse events (TRAEs), and the rate of intervention adjustments due to adverse events.
Secondary Endpoints: PFS, ORR, and OS.
Statistical Analysis:
Descriptive statistics will be used to calculate the incidence rates and 95% confidence intervals for primary endpoints.
Kaplan-Meier methods will be used for secondary endpoints to estimate survival functions and calculate median survival times with 95% confidence intervals.
Duration:
The study is expected to last for approximately two years from the initiation of the study to the completion of data analysis.
Research Team:
The project is led by Principal Investigator Dr. Hong Qingqi, who is a Chief Physician. The team includes a multidisciplinary group of professionals, including other physicians, nurses, and researchers, all of whom have received Good Clinical Practice (GCP) training.
Ethical Considerations:
The study will adhere to the principles of the Declaration of Helsinki and will be approved by the hospital's ethics committee before initiation.
Informed consent will be obtained from all participants or their legal representatives.
Data Management:
All data will be collected, managed, and stored in accordance with GCP guidelines and relevant regulations to ensure confidentiality and integrity.
This study aims to provide a comprehensive evaluation of the safety and potential benefits of yFMT in combination with immunotherapy and chemotherapy for MSS mCRC, potentially offering a new treatment paradigm for this challenging disease.
- Being tested
- yFMT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yFMTDrug
Also called FOLFIRI Regimen, PD-1 Inhibitor
This study evaluates a triple-combination therapy for MSS mCRC comprising: (1) yFMT (6 biweekly sessions via nasogastric tube or oral capsules using young-donor fecal microbiota to modulate gut microbiome); (2) weight-based PD-1 inhibitor immunotherapy; and (3) FOLFIRI chemotherapy (fluorouracil, leucovorin, irinotecan) synchronized biweekly with yFMT. The 3-month treatment period tests the hypothesis that yFMT enhances immunotherapy efficacy through microbiome-mediated immune modulation, followed by 9-month follow-up. Safety monitoring includes prompt adverse event management and regimen adjustments as needed.
| Study group | Role | What they receive |
|---|---|---|
| yFMT + PD-1 Inhibitor + FOLFIRI Group | Experimental | This study evaluates a combined intervention of young-donor fecal microbiota transplantation (yFMT), PD-1 inhibitor immunotherapy, and FOLFIRI chemotherapy for microsatellite stable metastatic colorectal cancer (MSS mCRC) patients. yFMT (6 sessions every 2 weeks via nasogastric tube or oral capsules) aims to modulate the gut microbiome and enhance immune response, administered concurrently with weight-based PD-1 inhibitor and FOLFIRI regimen (fluorouracil, leucovorin, irinotecan) synchronized every 2 weeks. This 3-month treatment period, followed by 9-month follow-up, tests the hypothesis that yFMT synergistically improves immunotherapy efficacy through microbiome alteration. Patients are closely monitored for adverse events with prompt management and regimen adjustments to ensure safety. Receives: Drug: yFMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of serious adverse events (SAEs)
The proportion of patients experiencing serious adverse events (Grade ≥3 per CTCAE v5.0) during the treatment and follow-up period, including events related to yFMT, immunotherapy, or chemotherapy that result in death, life-threatening conditions, hospitalization, or persistent disability.
Measured: From the initiation of yFMT treatment to the completion of follow-up
treatment-related adverse events (TRAEs)
The incidence of adverse events assessed as related to the study intervention (yFMT, PD-1 inhibitor, or FOLFIRI regimen) by the investigator, graded according to CTCAE v5.0, occurring from treatment initiation through the follow-up period.
Measured: From the initiation of yFMT treatment to the completion of follow-up
the rate of intervention adjustments due to adverse events
The proportion of patients requiring dose reduction, treatment interruption, or discontinuation of yFMT, immunotherapy, or chemotherapy due to treatment-related adverse events, documented with reasons and duration of adjustments.
Measured: From the initiation of yFMT treatment to the completion of follow-up
Secondary outcomes (3)
PFS
Progression-free survival, defined as the time from treatment initiation to radiographic disease progression (per RECIST v1.1) or death from any cause, whichever occurs first.
Measured: From treatment initiation to radiographic disease progression (per RECIST v1.1) or death from any cause, whichever occurs first.
ORR
Objective response rate, defined as the proportion of patients achieving complete response (CR) or partial response (PR) as assessed by investigators according to RECIST v1.1 criteria.
Measured: Objective response will be assessed every 6-8 weeks from the initiation of yFMT treatment until disease progression, death, or completion of 12-month study period (3-month treatment + 9-month follow-up), whichever occurs first.
OS
Overall survival, defined as the time from treatment initiation to death from any cause.
Measured: From treatment initiation until death (any cause) or last known alive date, up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start31 Mar 2026 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intervention: Young-donor fecal microbiota transplantation (yFMT) combined with PD-1 inhibitor immunotherapy and FOLFIRI chemotherapy for MSS mCRC patients. yFMT: 6 sessions every 2 weeks (nasogastric tube or oral capsules) using fecal microbiota from young donors to modulate gut microbiome and enhance immune response. Immunotherapy: Weight-based PD-1 inhibitor to block the PD-1 pathway. Chemotherapy: FOLFIRI regimen (fluorouracil, leucovorin, irinotecan) every 2 weeks, synchronized with yFMT. Rationale: Synergistic approach where yFMT may improve immunotherapy efficacy by altering gut microbiome to enhance anti-tumor immune response. Duration: 3-month treatment period followed by 9-month follow-up. Safety: Close monitoring for adverse events with prompt management and regimen adjustments as needed. Objective: Explore yFMT's potential to enhance immunotherapy and chemotherapy effectiveness in MSS mCRC.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingqi Hong, The First Affiliated Hospital of Xiamen University
- Investigators
- Qingqi Hong, MD, Principal investigator, The First Affiliated Hospital of Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486492
- Sponsor's protocol ID
- XMYY-2026KY036
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
PubMed 38572751Wang FH, Zhang XT, Tang L, Wu Q, Cai MY, Li YF, Qu XJ, Qiu H, Zhang YJ, Ying JE, Zhang J, Sun LY, Lin RB, Wang C, Liu H, Qiu MZ, Guan WL, Rao SX, Ji JF, Xin Y, Sheng WQ, Xu HM, Zhou ZW, Zhou AP, Jin J, Yuan XL, Bi F, Liu TS, Liang H, Zhang YQ, Li GX, Liang J, Liu BR, Shen L, Li J, Xu RH. The Chinese Society of Clinical Oncology (CSCO): Clinical guidelines for the diagnosis and treatment of gastric cancer, 2023. Cancer Commun (Lond). 2024 Jan;44(1):127-172. doi: 10.1002/cac2.12516. Epub 2023 Dec 31.
PubMed 38160327Gopalakrishnan V, Spencer CN, Nezi L, Reuben A, Andrews MC, Karpinets TV, Prieto PA, Vicente D, Hoffman K, Wei SC, Cogdill AP, Zhao L, Hudgens CW, Hutchinson DS, Manzo T, Petaccia de Macedo M, Cotechini T, Kumar T, Chen WS, Reddy SM, Szczepaniak Sloane R, Galloway-Pena J, Jiang H, Chen PL, Shpall EJ, Rezvani K, Alousi AM, Chemaly RF, Shelburne S, Vence LM, Okhuysen PC, Jensen VB, Swennes AG, McAllister F, Marcelo Riquelme Sanchez E, Zhang Y, Le Chatelier E, Zitvogel L, Pons N, Austin-Breneman JL, Haydu LE, Burton EM, Gardner JM, Sirmans E, Hu J, Lazar AJ, Tsujikawa T, Diab A, Tawbi H, Glitza IC, Hwu WJ, Patel SP, Woodman SE, Amaria RN, Davies MA, Gershenwald JE, Hwu P, Lee JE, Zhang J, Coussens LM, Cooper ZA, Futreal PA, Daniel CR, Ajami NJ, Petrosino JF, Tetzlaff MT, Sharma P, Allison JP, Jenq RR, Wargo JA. Gut microbiome modulates response to anti-PD-1 immunotherapy in melanoma patients. Science. 2018 Jan 5;359(6371):97-103. doi: 10.1126/science.aan4236. Epub 2017 Nov 2.
PubMed 29097493Sivan A, Corrales L, Hubert N, Williams JB, Aquino-Michaels K, Earley ZM, Benyamin FW, Lei YM, Jabri B, Alegre ML, Chang EB, Gajewski TF. Commensal Bifidobacterium promotes antitumor immunity and facilitates anti-PD-L1 efficacy. Science. 2015 Nov 27;350(6264):1084-9. doi: 10.1126/science.aac4255. Epub 2015 Nov 5.
PubMed 26541606Zhao W, Lei J, Ke S, Chen Y, Xiao J, Tang Z, Wang L, Ren Y, Alnaggar M, Qiu H, Shi W, Yin L, Chen Y. Fecal microbiota transplantation plus tislelizumab and fruquintinib in refractory microsatellite stable metastatic colorectal cancer: an open-label, single-arm, phase II trial (RENMIN-215). EClinicalMedicine. 2023 Nov 14;66:102315. doi: 10.1016/j.eclinm.2023.102315. eCollection 2023 Dec.
PubMed 38024475Yu H, Li XX, Han X, Chen BX, Zhang XH, Gao S, Xu DQ, Wang Y, Gao ZK, Yu L, Zhu SL, Yao LC, Liu GR, Liu SL, Mu XQ. Fecal microbiota transplantation inhibits colorectal cancer progression: Reversing intestinal microbial dysbiosis to enhance anti-cancer immune responses. Front Microbiol. 2023 Apr 18;14:1126808. doi: 10.3389/fmicb.2023.1126808. eCollection 2023.
PubMed 37143538Davar D, Zarour HM. Facts and Hopes for Gut Microbiota Interventions in Cancer Immunotherapy. Clin Cancer Res. 2022 Oct 14;28(20):4370-4384. doi: 10.1158/1078-0432.CCR-21-1129.
PubMed 35748749De Lucia SS, Nista EC, Candelli M, Archilei S, Deutschbein F, Capuano E, Gasbarrini A, Franceschi F, Pignataro G. Microbiota and Pancreatic Cancer: New Therapeutic Frontiers Between Engineered Microbes, Metabolites and Non-Bacterial Components. Cancers (Basel). 2025 Nov 10;17(22):3618. doi: 10.3390/cancers17223618.
PubMed 41300985Zhu X, Hu M, Huang X, Li L, Lin X, Shao X, Li J, Du X, Zhang X, Sun R, Tong T, Ma Y, Ning L, Jiang Y, Zhang Y, Shao Y, Wang Z, Zhou Y, Ding J, Zhao Y, Xuan B, Zhang H, Zhang Y, Hong J, Fang JY, Xiao X, Shen B, He S, Chen H. Interplay between gut microbial communities and metabolites modulates pan-cancer immunotherapy responses. Cell Metab. 2025 Apr 1;37(4):806-823.e6. doi: 10.1016/j.cmet.2024.12.013. Epub 2025 Feb 4.
PubMed 39909032
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Fecal Microbiota Transplantation (FMT) Combined With Immunotherapy and Chemotherapy in Microsatellite Stable Metastatic Colorectal Cancer (MSS mCRC)
- ClinicalTrials.gov ID
- NCT07486492
- Acronym / sponsor ID
- XMYY-2026KY036
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 31 Mar 2026 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research protocol outlines an exploratory study on the combination of early-life fecal microbiota transplantation (yFMT) with immunotherapy and chemotherapy in patients with microsatellite stable metastatic colorectal cancer (MSS mCRC). The single-center, single-arm study aims to assess the safety of yFMT in conjunction with immunotherapy and chemotherapy, with a secondary focus on exploring its efficacy and impact on the patients' immune microenvironment. The study will enroll 10 patients aged 18-75 who have progressed after first-line chemotherapy and targeted therapy. The intervention involves six sessions of yFMT every two weeks, alongside PD-1 inhibitor immunotherapy and FOLFIRI chemotherapy. The primary endpoints are the incidence of serious adverse events (SAEs), treatment-related adverse events (TRAEs), and intervention adjustments due to adverse events, while secondary endpoints include progression-free survival (PFS), objective response rate (ORR), and overall survival (OS). The study is expected to last two years from initiation to data analysis completion, and it will be conducted at the Gastrointestinal Tumor Surgery Department of the First Affiliated Hospital of Xiamen University.
Detailed description
The research protocol for the study titled "Exploratory Study of Early Life Fecal Microbiota Transplantation (yFMT) Combined with Immunotherapy and Chemotherapy in Microsatellite Stable Metastatic Colorectal Cancer (MSS mCRC)" is designed to investigate a novel treatment approach for patients with MSS mCRC, a group that typically does not respond well to immunotherapy. The study is being conducted at the Gastrointestinal Tumor Surgery Department of the First Affiliated Hospital of Xiamen University.
Objectives:
Primary Objective: To evaluate the safety of combining yFMT with immunotherapy (PD-1 inhibitor) and chemotherapy (FOLFIRI) in patients with MSS mCRC.
Secondary Objectives: To explore the efficacy of the combined treatment in terms of progression-free survival (PFS), objective response rate (ORR), and overall survival (OS), as well as to assess the impact of yFMT on the patients' immune microenvironment and its potential synergistic effects with immunotherapy and chemotherapy.
Study Design:
The study is a single-center, single-arm trial with a total of 10 participants. The study timeline includes a screening period of 2 weeks, a treatment period of 3 months, and a follow-up period of 9 months.
Participants:
The study will enroll 10 patients aged between 18 and 75 years, regardless of gender.
Inclusion Criteria: Patients must have a confirmed diagnosis of MSS mCRC, must have experienced disease progression after first-line chemotherapy and targeted therapy, and must have an ECOG performance status of 0-1.
Exclusion Criteria: Patients with a history of FMT, severe organ dysfunction (heart, lung, liver, kidney), other malignancies, psychiatric disorders, pregnancy or lactation, and those unable to provide informed consent will be excluded.
Interventions:
Participants will receive yFMT every two weeks for a total of six sessions, along with PD-1 inhibitor immunotherapy and FOLFIRI chemotherapy.
Endpoints:
Primary Endpoints: The incidence of serious adverse events (SAEs), treatment-related adverse events (TRAEs), and the rate of intervention adjustments due to adverse events.
Secondary Endpoints: PFS, ORR, and OS.
Statistical Analysis:
Descriptive statistics will be used to calculate the incidence rates and 95% confidence intervals for primary endpoints.
Kaplan-Meier methods will be used for secondary endpoints to estimate survival functions and calculate median survival times with 95% confidence intervals.
Duration:
The study is expected to last for approximately two years from the initiation of the study to the completion of data analysis.
Research Team:
The project is led by Principal Investigator Dr. Hong Qingqi, who is a Chief Physician. The team includes a multidisciplinary group of professionals, including other physicians, nurses, and researchers, all of whom have received Good Clinical Practice (GCP) training.
Ethical Considerations:
The study will adhere to the principles of the Declaration of Helsinki and will be approved by the hospital's ethics committee before initiation.
Informed consent will be obtained from all participants or their legal representatives.
Data Management:
All data will be collected, managed, and stored in accordance with GCP guidelines and relevant regulations to ensure confidentiality and integrity.
This study aims to provide a comprehensive evaluation of the safety and potential benefits of yFMT in combination with immunotherapy and chemotherapy for MSS mCRC, potentially offering a new treatment paradigm for this challenging disease.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intervention: Young-donor fecal microbiota transplantation (yFMT) combined with PD-1 inhibitor immunotherapy and FOLFIRI chemotherapy for MSS mCRC patients. yFMT: 6 sessions every 2 weeks (nasogastric tube or oral capsules) using fecal microbiota from young donors to modulate gut microbiome and enhance immune response. Immunotherapy: Weight-based PD-1 inhibitor to block the PD-1 pathway. Chemotherapy: FOLFIRI regimen (fluorouracil, leucovorin, irinotecan) every 2 weeks, synchronized with yFMT. Rationale: Synergistic approach where yFMT may improve immunotherapy efficacy by altering gut microbiome to enhance anti-tumor immune response. Duration: 3-month treatment period followed by 9-month follow-up. Safety: Close monitoring for adverse events with prompt management and regimen adjustments as needed. Objective: Explore yFMT's potential to enhance immunotherapy and chemotherapy effectiveness in MSS mCRC.
| Arm | Type | Receives |
|---|---|---|
| yFMT + PD-1 Inhibitor + FOLFIRI Group | Experimental | Drug: yFMTThis study evaluates a combined intervention of young-donor fecal microbiota transplantation (yFMT), PD-1 inhibitor immunotherapy, and FOLFIRI chemotherapy for microsatellite stable metastatic colorectal cancer (MSS mCRC) patients. yFMT (6 sessions every 2 weeks via nasogastric tube or oral capsules) aims to modulate the gut microbiome and enhance immune response, administered concurrently with weight-based PD-1 inhibitor and FOLFIRI regimen (fluorouracil, leucovorin, irinotecan) synchronized every 2 weeks. This 3-month treatment period, followed by 9-month follow-up, tests the hypothesis that yFMT synergistically improves immunotherapy efficacy through microbiome alteration. Patients are closely monitored for adverse events with prompt management and regimen adjustments to ensure safety. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically or cytologically confirmed diagnosis of MSS mCRC
- Experienced disease progression after first-line chemotherapy and targeted therapy
- ECOG performance status of 0-1
Key exclusion criteria (4 listed)
- History of FMT
- Severe organ dysfunction (heart, lung, liver, kidney)
- Other malignancies, psychiatric disorders, pregnancy or lactation
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| yFMTAlso: FOLFIRI Regimen, PD-1 InhibitorThis study evaluates a triple-combination therapy for MSS mCRC comprising: (1) yFMT (6 biweekly sessions via nasogastric tube or oral capsules using young-donor fecal microbiota to modulate gut microbiome); (2) weight-based PD-1 inhibitor immunotherapy; and (3) FOLFIRI chemotherapy (fluorouracil, leucovorin, irinotecan) synchronized biweekly with yFMT. The 3-month treatment period tests the hypothesis that yFMT enhances immunotherapy efficacy through microbiome-mediated immune modulation, followed by 9-month follow-up. Safety monitoring includes prompt adverse event management and regimen adjustments as needed. | Drug | yFMT + PD-1 Inhibitor + FOLFIRI Group |
Primary outcome
The incidence of serious adverse events (SAEs)
Time frame: From the initiation of yFMT treatment to the completion of follow-up
The proportion of patients experiencing serious adverse events (Grade ≥3 per CTCAE v5.0) during the treatment and follow-up period, including events related to yFMT, immunotherapy, or chemotherapy that result in death, life-threatening conditions, hospitalization, or persistent disability.
treatment-related adverse events (TRAEs)
Time frame: From the initiation of yFMT treatment to the completion of follow-up
The incidence of adverse events assessed as related to the study intervention (yFMT, PD-1 inhibitor, or FOLFIRI regimen) by the investigator, graded according to CTCAE v5.0, occurring from treatment initiation through the follow-up period.
the rate of intervention adjustments due to adverse events
Time frame: From the initiation of yFMT treatment to the completion of follow-up
The proportion of patients requiring dose reduction, treatment interruption, or discontinuation of yFMT, immunotherapy, or chemotherapy due to treatment-related adverse events, documented with reasons and duration of adjustments.
3 secondary outcomes
PFS
Time frame: From treatment initiation to radiographic disease progression (per RECIST v1.1) or death from any cause, whichever occurs first.
ORR
Time frame: Objective response will be assessed every 6-8 weeks from the initiation of yFMT treatment until disease progression, death, or completion of 12-month study period (3-month treatment + 9-month follow-up), whichever occurs first.
OS
Time frame: From treatment initiation until death (any cause) or last known alive date, up to 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Results publication: PubMed 38572751Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
- Results publication: PubMed 38160327Wang FH, Zhang XT, Tang L, Wu Q, Cai MY, Li YF, Qu XJ, Qiu H, Zhang YJ, Ying JE, Zhang J, Sun LY, Lin RB, Wang C, Liu H, Qiu MZ, Guan WL, Rao SX, Ji JF, Xin Y, Sheng WQ, Xu HM, Zhou ZW, Zhou AP, Jin J, Yuan XL, Bi F, Liu TS, Liang H, Zhang YQ, Li GX, Liang J, Liu BR, Shen L, Li J, Xu RH. The Chinese Society of Clinical Oncology (CSCO): Clinical guidelines for the diagnosis and treatment of gastric cancer, 2023. Cancer Commun (Lond). 2024 Jan;44(1):127-172. doi: 10.1002/cac2.12516. Epub 2023 Dec 31.
- Results publication: PubMed 29097493Gopalakrishnan V, Spencer CN, Nezi L, Reuben A, Andrews MC, Karpinets TV, Prieto PA, Vicente D, Hoffman K, Wei SC, Cogdill AP, Zhao L, Hudgens CW, Hutchinson DS, Manzo T, Petaccia de Macedo M, Cotechini T, Kumar T, Chen WS, Reddy SM, Szczepaniak Sloane R, Galloway-Pena J, Jiang H, Chen PL, Shpall EJ, Rezvani K, Alousi AM, Chemaly RF, Shelburne S, Vence LM, Okhuysen PC, Jensen VB, Swennes AG, McAllister F, Marcelo Riquelme Sanchez E, Zhang Y, Le Chatelier E, Zitvogel L, Pons N, Austin-Breneman JL, Haydu LE, Burton EM, Gardner JM, Sirmans E, Hu J, Lazar AJ, Tsujikawa T, Diab A, Tawbi H, Glitza IC, Hwu WJ, Patel SP, Woodman SE, Amaria RN, Davies MA, Gershenwald JE, Hwu P, Lee JE, Zhang J, Coussens LM, Cooper ZA, Futreal PA, Daniel CR, Ajami NJ, Petrosino JF, Tetzlaff MT, Sharma P, Allison JP, Jenq RR, Wargo JA. Gut microbiome modulates response to anti-PD-1 immunotherapy in melanoma patients. Science. 2018 Jan 5;359(6371):97-103. doi: 10.1126/science.aan4236. Epub 2017 Nov 2.
- Results publication: PubMed 26541606Sivan A, Corrales L, Hubert N, Williams JB, Aquino-Michaels K, Earley ZM, Benyamin FW, Lei YM, Jabri B, Alegre ML, Chang EB, Gajewski TF. Commensal Bifidobacterium promotes antitumor immunity and facilitates anti-PD-L1 efficacy. Science. 2015 Nov 27;350(6264):1084-9. doi: 10.1126/science.aac4255. Epub 2015 Nov 5.
- Results publication: PubMed 38024475Zhao W, Lei J, Ke S, Chen Y, Xiao J, Tang Z, Wang L, Ren Y, Alnaggar M, Qiu H, Shi W, Yin L, Chen Y. Fecal microbiota transplantation plus tislelizumab and fruquintinib in refractory microsatellite stable metastatic colorectal cancer: an open-label, single-arm, phase II trial (RENMIN-215). EClinicalMedicine. 2023 Nov 14;66:102315. doi: 10.1016/j.eclinm.2023.102315. eCollection 2023 Dec.
- Results publication: PubMed 37143538Yu H, Li XX, Han X, Chen BX, Zhang XH, Gao S, Xu DQ, Wang Y, Gao ZK, Yu L, Zhu SL, Yao LC, Liu GR, Liu SL, Mu XQ. Fecal microbiota transplantation inhibits colorectal cancer progression: Reversing intestinal microbial dysbiosis to enhance anti-cancer immune responses. Front Microbiol. 2023 Apr 18;14:1126808. doi: 10.3389/fmicb.2023.1126808. eCollection 2023.
- Results publication: PubMed 35748749Davar D, Zarour HM. Facts and Hopes for Gut Microbiota Interventions in Cancer Immunotherapy. Clin Cancer Res. 2022 Oct 14;28(20):4370-4384. doi: 10.1158/1078-0432.CCR-21-1129.
- Results publication: PubMed 41300985De Lucia SS, Nista EC, Candelli M, Archilei S, Deutschbein F, Capuano E, Gasbarrini A, Franceschi F, Pignataro G. Microbiota and Pancreatic Cancer: New Therapeutic Frontiers Between Engineered Microbes, Metabolites and Non-Bacterial Components. Cancers (Basel). 2025 Nov 10;17(22):3618. doi: 10.3390/cancers17223618.
- Results publication: PubMed 39909032Zhu X, Hu M, Huang X, Li L, Lin X, Shao X, Li J, Du X, Zhang X, Sun R, Tong T, Ma Y, Ning L, Jiang Y, Zhang Y, Shao Y, Wang Z, Zhou Y, Ding J, Zhao Y, Xuan B, Zhang H, Zhang Y, Hong J, Fang JY, Xiao X, Shen B, He S, Chen H. Interplay between gut microbial communities and metabolites modulates pan-cancer immunotherapy responses. Cell Metab. 2025 Apr 1;37(4):806-823.e6. doi: 10.1016/j.cmet.2024.12.013. Epub 2025 Feb 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qingqi Hong, MD principal investigator
The First Affiliated Hospital of Xiamen University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing yFMT in people with Colorectal Cancer Metastatic and Fecal Microbiota Transplantation, run by The First Affiliated Hospital of Xiamen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. 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: opening soon, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Qingqi Hong, MD (15980809201, hqqsums@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of serious adverse events (SAEs) (time frame: From the initiation of yFMT treatment to the completion of follow-up). The study lists 3 primary outcomes in all. 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 NCT07486492, which also lists 9 linked publications.
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 20 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.