Gastrointestinal System CancerPhase 1NCT04130763
Fecal Microbiota Transplant (FMT) Capsule for Improving the Efficacy of Anti- PD-1
A Phase 1 study testing FMT capsule in people with Gastrointestinal System Cancer, run by Peking University at 1 site in China.
Trial summary
To determine whether the fecal microbiota transplant (FMT) capsule can help reverse the resistance of anti-PD-(L)1 treatment in Gastrointestinal (GI) cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastrointestinal System Cancer
- What is being tested?
- FMT capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2019to 29 Jan 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient had a histologically or cytologically confirmed diagnosis of unresectable or metastatic solid tumors originating from the GI tract.
- Patient was able and willing to provide pathological tissue embedded in wax blocks or paraffin sections.
- Patient had received any number of radiation therapy, chemotherapy, vaccine therapy or other oncological therapy are permitted.
- Patient was receiving or has received at least 2-dose injections of systemic PD-(L)1 immunotherapy, and imaging results confirmed progressive disease (PD). According to iRECIST, PD is defined as an increase in the length of the lesion > 20% or occurrence of new lesion or non-target lesion progression. Anti-PD-(L)1 drugs can contain pembrolizumab, nivolumab or any other anti-PD-(L)1 drugs that have passed phase 2 clinical development. Patients are eligible when the previous failed anti-PD-(L)1 treatment was initiated within one year of the first dose of this trial.
- Patient was willing and able to swallow at least 20 FMT capsules.
- Patient was willing and able to sign the informed consent form.
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- Patient consented to receive follow-up medical imaging to determine disease progression and provide stool samples before and after taking capsules at each follow-up visit.
- Patient was at least 18 years old, male or female.
- Patient had an ECOG performance of 0 or 1.
- For women with childbearing potential, the results of blood pregnancy test within 7 days prior to enrollment or the results of urine pregnancy test within 72 hours prior to enrollment had to be negative.
- Patient must have had basic body function. Blood test results needed to reach the following indexes: Absolute neutrophil count (ANC)≥1500/mcL, platelets≥100,000/mcL, hemoglobin≥9 g/dL or 5.6 mmol/L, no transfusion or EPO dependency (within 7 days of assessment), serum creatinine≤1.5×upper limit of normal (ULN) or creatinine clearance≥60 mL/min, serum total bilirubin≤1.5×ULN or direct bilirubin≤ULN, AST (SGOT) and ALT (SGPT)≤2.5×ULN for patients with serum total bilirubin >1.5 ULN or ≤5×ULN for patients with liver metastases, albumin≥2.5 mg/dL, coagulation indexes INR or PT ≤1.5×ULN. Unless patient was receiving anticoagulant therapy, coagulation indexes were within normal range of therapy.
- Expected survival duration ≥3 months.
Who cannot join
- Patient with irritable bowel syndrome, toxic megacolon, and severe dietary allergies (including severe allergic to shellfish, nuts, seafood).
- Patient had responded to anti-PD-(L)1 therapy or had a stable disease status (per iRECIST at CR, PR, or SD).
- Patient had participated in any other clinical trial within 4 weeks before the first dose of FMT capsule treatment.
- Patient had highly severe symptoms including rapidly declining ECOG performance; rapidly worsening symptoms; lesion transferring to critical sites and requiring urgent medical intervention.
- Patient had a known history of malignant blood diseases, primary brain tumor or sarcoma, or other primary solid tumors except gastrointestinal tumors.
- Patient had progressing CNS metastases or leptomeningeal metastases. Patients with stable brain metastases had to be re-screened by brain MRI or CT scan within two weeks before enrollment to ensure no disease progression, and simultaneously take ≤10mg steroid daily one week prior to treatment. Patients with no history of CNS metastases and no signs of CNS metastases did not need another medical imaging examination for brain diseases.
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- Patient had a severe hypersensitivity or reaction to anti-PD-(L)1 immunotherapy.
- Patient had an autoimmune disease or a history of autoimmune disease or required treatment with systemic steroid (prednisone >10 mg daily or equivalent dose of similar drugs) or immunosuppressive agents. The following cases were exceptions: local, ophthalmic, intra-articular, intranasal, or inhaled corticosteroids with extremely low systemic absorption; hormone replacement therapy; short-term (≤7 days) treatment of corticosteroids for preventative use (e.g., allergy to contrast agents).
- Patient had pneumonitis or had a history of (non-infectious) pneumonitis requiring steroid therapy.
- Patient had severe cardiovascular disease (e.g., drug-uncontrolled congestive heart failure, hypertension, cardiac ischemia, myocardial infarction, and severe cardiac arrhythmia), bleeding disorders, severe obstructive or restrictive pulmonary diseases, or systemic infections.
- Patient had active human immunodeficiency virus (HIV) infection (performance as HIV 1/2 antibodies and/or positive).
- Patient had active Hepatitis B (HBV) or Hepatitis C (HCV) infection.
- Patient had known active tuberculosis.
- Patient had received a live vaccine or live attenuated vaccine within 4 weeks prior to enrollment.
- Patient had reported adverse events (per CTCAE 5.0, ≥grade 2) due to drug treatment within 4 weeks and not recovered from it. Patients who had undergone major surgery had to have completely recovered from toxicity and complications of previous interventions prior to participating in the study.
- Patient had received anti-tumor therapy except experimental drugs (e.g., chemotherapy, targeted small molecule therapy or radiotherapy) within 2 weeks prior to screening or planned to receive anti-tumor therapy except experimental drugs (e.g., chemotherapy, targeted small molecule therapy or radiotherapy) during the study period. Radiotherapy used for pain control was an exception.
- Patient had a known history of psychiatric disorders or drug abuse.
- Patient was pregnant or breastfeeding, or subjects (including male subject and his female spouse) could not take effective contraceptive measures at the time of signing the informed consent until 120 days after the final anti-PD-1 therapy combined with FMT treatment.
- Patient could not stop antibiotics treatment 24 hours before administration due to infection, etc.
- Other cases that investigators qualified as relevant for patients who could not participate in the study, e.g., any medical history, treatment history, or history of abnormal test data that possibly confuses the study results, or interferes with patients' participation in the whole study, or damages patient interests.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigator-initiated Trial of Fecal Microbiota Transplant (FMT) Capsule for Improving the Efficacy of Anti-PD-1 in Patients with PD-(L)1 Resistant Digestive System Cancers
To determine whether the fecal microbiota transplant (FMT) capsule can help reverse the resistance of anti-PD-(L)1 treatment in Gastrointestinal (GI) cancer patients.
Read the detailed description
This study is designed to improve the response rate of anti-PD-(L)1 among patients with anti-PD-(L)1 resistant/refractory digestive (including gullet, stomach and intestine) system cancers through the intervention on their gut microbiota. Healthy people who have the gut microbiota profile similar to the responders of anti-PD-(L)1 therapy will be identified. The gut microbiota of these healthy people will be extracted to product FMT capsule. Gastrointestinal (GI) cancer patients who failed anti-PD-(L)1 treatment will be administrated with anti-PD-1 immunotherapy combined with FMT. The enrolled subjects will firstly receive 1-week of FMT therapy. Subsequently, each anti-PD-1 treatment will be combined with the maintenance dose of FMT capsules to ensure the efficiency of gut microbiota colonization. Each subject will receive anti-PD-1 therapy for 6 cycles. After the completion of both 3 and 6 cycles of therapy, safety and efficacy assessments will be conducted. The subjects who complete 3 cycles of treatment but are clinically evaluated as disease progression will not continue to the following 3 cycles of treatment.
- Conditions
- Gastrointestinal System Cancer
- Being tested
- FMT capsule
- Keywords
- Immuno-checkpoint inhibitor therapy, GI cancer, FMT
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMT capsuleBiological
FMT capsules administration starts in the first week of enrollment. Capsules are taken for three consecutive days in the first week. From week 2, anti-PD-1 therapy will be administrated in combination with the maintenance dose of FMT treatment once every two weeks for up to 6 times.
| Study group | Role | What they receive |
|---|---|---|
| FMT Capsule in Combination with Anti-PD-1 Therapy | Experimental | FMT Capsule in Combination with Anti-PD-1 Therapy Receives: Biological: FMT capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Number of subjects with objective responses (Complete Response (CR) + Partial Response (PR)) divided by total number of subjects, per iRECIST.
Measured: 14 weeks
The number of adverse events
The number of adverse events that is related to FMT prior to the first anti-PD-1 immunotherapy treatment.
Measured: 1 week
Rate of abnormal vital signs and laboratory test results
Rate of abnormal vital signs and laboratory test results that are determined to be clinically significant prior to the first anti-PD-1 immunotherapy treatment.
Measured: 1 week
Secondary outcomes (6)
Change in T-cells Composition
Compare the changes in CD8+PD-1+T cells, Ki67+CD8+ T cells before and after treatment between response subjects and non-response subjects (evaluated by iRECIST).
Measured: 14 weeks
Function of T-cells
Compare the changes in cells expressing IFN-γ before and after treatment between response subjects and non-response subjects (per iRECIST).
Measured: 14 weeks
Association of anti-PD-1 response with gut microbiota
Compare the changes in bacterial abundance and bacterial diversity before and after treatment between response subjects and non-response subjects (per iRECIST).
Measured: 14 weeks
Rate of abnormal vital signs, physical examination results, 12-lead electrocardiogram and laboratory test results
Rate of abnormal vital signs, physical examination results, 12-lead electrocardiogram and laboratory test results that are determined to be clinically significant from the beginning of the first anti-PD-1 immunotherapy treatment to the end of study.
Measured: 14 weeks
Change in subsets of specific and non-specific immune system
Compare the changes in T-cell receptor diversity (quantified by immune repertoire sequencing analyses), CD8+CCR7+CD45RA+T cells, CD4+CCR7+CD45RA+ T cells ,CD4 + Foxp3 + T cells,CD56+NK cells and CD68+ cells before and after treatment between response subjects and non-response subjects (evaluated by iRECIST).
Measured: 14 weeks
The number of adverse events
The number of adverse events from the beginning of the first anti-PD-1 immunotherapy treatment to the end of study
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start5 Dec 2019
- Primary completion1 Feb 2023
- Study completion29 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal System CancerStudies of the same condition, open and under way.
- More trials run by Peking 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Lin, Peking University
- Investigators
- Lin Shen, MD, Principal investigator, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130763
- Sponsor's protocol ID
- XBI-302CT1001
- Status last verified
- Sep 2024
- First submitted
- 13 Oct 2019
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang Y, Xu X, Wang S, Yin X, Zhang B, Zhu Z, Ji R, Zhu J, He H, Cheng S, Han Z, Xie T, Zhang X, Wang Y, Shen S, Kou Y, Bao S, Liu Y, Cao B, Bonny C, Guo X, Segal E, Tan Y, Shen L, Peng Z. Fecal microbiota transplantation combined with anti-PD-1 therapy in refractory microsatellite-stable gastric cancer: a phase I feasibility and safety study. J Immunother Cancer. 2026 Mar 23;14(3):e013823. doi: 10.1136/jitc-2025-013823.
PubMed 41871875
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigator-initiated Trial of Fecal Microbiota Transplant (FMT) Capsule for Improving the Efficacy of Anti-PD-1 in Patients with PD-(L)1 Resistant Digestive System Cancers
- ClinicalTrials.gov ID
- NCT04130763
- Acronym / sponsor ID
- XBI-302CT1001
- Conditions
- Gastrointestinal System Cancer
- Keywords
- Immuno-checkpoint inhibitor therapy, GI cancer, FMT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 5 Dec 2019 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 29 Jan 2024 (actual)
- First posted
- 17 Oct 2019 (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.
To determine whether the fecal microbiota transplant (FMT) capsule can help reverse the resistance of anti-PD-(L)1 treatment in Gastrointestinal (GI) cancer patients.
Detailed description
This study is designed to improve the response rate of anti-PD-(L)1 among patients with anti-PD-(L)1 resistant/refractory digestive (including gullet, stomach and intestine) system cancers through the intervention on their gut microbiota. Healthy people who have the gut microbiota profile similar to the responders of anti-PD-(L)1 therapy will be identified. The gut microbiota of these healthy people will be extracted to product FMT capsule. Gastrointestinal (GI) cancer patients who failed anti-PD-(L)1 treatment will be administrated with anti-PD-1 immunotherapy combined with FMT. The enrolled subjects will firstly receive 1-week of FMT therapy. Subsequently, each anti-PD-1 treatment will be combined with the maintenance dose of FMT capsules to ensure the efficiency of gut microbiota colonization. Each subject will receive anti-PD-1 therapy for 6 cycles. After the completion of both 3 and 6 cycles of therapy, safety and efficacy assessments will be conducted. The subjects who complete 3 cycles of treatment but are clinically evaluated as disease progression will not continue to the following 3 cycles of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FMT Capsule in Combination with Anti-PD-1 Therapy | Experimental | Biological: FMT capsuleFMT Capsule in Combination with Anti-PD-1 Therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient had a histologically or cytologically confirmed diagnosis of unresectable or metastatic solid tumors originating from the GI tract.
- Patient was able and willing to provide pathological tissue embedded in wax blocks or paraffin sections.
- Patient had received any number of radiation therapy, chemotherapy, vaccine therapy or other oncological therapy are permitted.
- Patient was receiving or has received at least 2-dose injections of systemic PD-(L)1 immunotherapy, and imaging results confirmed progressive disease (PD). According to iRECIST, PD is defined as an increase in the length of the lesion > 20% or occurrence of new lesion or non-target lesion progression. Anti-PD-(L)1 drugs can contain pembrolizumab, nivolumab or any other anti-PD-(L)1 drugs that have passed phase 2 clinical development. Patients are eligible when the previous failed anti-PD-(L)1 treatment was initiated within one year of the first dose of this trial.
- Patient was willing and able to swallow at least 20 FMT capsules.
Key exclusion criteria (20 listed)
- Patient with irritable bowel syndrome, toxic megacolon, and severe dietary allergies (including severe allergic to shellfish, nuts, seafood).
- Patient had responded to anti-PD-(L)1 therapy or had a stable disease status (per iRECIST at CR, PR, or SD).
- Patient had participated in any other clinical trial within 4 weeks before the first dose of FMT capsule treatment.
- Patient had highly severe symptoms including rapidly declining ECOG performance; rapidly worsening symptoms; lesion transferring to critical sites and requiring urgent medical intervention.
- Patient had a known history of malignant blood diseases, primary brain tumor or sarcoma, or other primary solid tumors except gastrointestinal tumors.
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 |
|---|---|---|
| FMT capsuleFMT capsules administration starts in the first week of enrollment. Capsules are taken for three consecutive days in the first week. From week 2, anti-PD-1 therapy will be administrated in combination with the maintenance dose of FMT treatment once every two weeks for up to 6 times. | Biological | FMT Capsule in Combination with Anti-PD-1 Therapy |
Primary outcome
Objective Response Rate (ORR)
Time frame: 14 weeks
Number of subjects with objective responses (Complete Response (CR) + Partial Response (PR)) divided by total number of subjects, per iRECIST.
The number of adverse events
Time frame: 1 week
The number of adverse events that is related to FMT prior to the first anti-PD-1 immunotherapy treatment.
Rate of abnormal vital signs and laboratory test results
Time frame: 1 week
Rate of abnormal vital signs and laboratory test results that are determined to be clinically significant prior to the first anti-PD-1 immunotherapy treatment.
6 secondary outcomes
Change in T-cells Composition
Time frame: 14 weeks
Function of T-cells
Time frame: 14 weeks
Association of anti-PD-1 response with gut microbiota
Time frame: 14 weeks
Rate of abnormal vital signs, physical examination results, 12-lead electrocardiogram and laboratory test results
Time frame: 14 weeks
Change in subsets of specific and non-specific immune system
Time frame: 14 weeks
The number of adverse events
Time frame: 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Derived from this study: PubMed 41871875Zhang Y, Xu X, Wang S, Yin X, Zhang B, Zhu Z, Ji R, Zhu J, He H, Cheng S, Han Z, Xie T, Zhang X, Wang Y, Shen S, Kou Y, Bao S, Liu Y, Cao B, Bonny C, Guo X, Segal E, Tan Y, Shen L, Peng Z. Fecal microbiota transplantation combined with anti-PD-1 therapy in refractory microsatellite-stable gastric cancer: a phase I feasibility and safety study. J Immunother Cancer. 2026 Mar 23;14(3):e013823. doi: 10.1136/jitc-2025-013823.
- 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. This study is not recruiting at the moment.
Lin Shen, MD principal investigator
Peking University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FMT capsule in people with Gastrointestinal System Cancer, run by Peking University at 1 site in China.
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 12 inclusion and 20 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: finished, as of the sponsor's last update on 24 Sep 2024. 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 China. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: 14 weeks). 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 NCT04130763, 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 24 Sep 2024.