Gastric CancerNCT07400354
The Efficacy of PD-1 Monoclonal Antibody Combined With Chemotherapy in Metastatic Gastric Cancer Based on Gut Microbiota
An observational study of Gastric Cancer and Gut Microbiota, run by Fudan University at 1 site in China.
Trial summary
This study is designed as a single-center, open-label, phase II exploratory trial. Patients with advanced or locally advanced gastric cancer who have not received chemotherapy or immunotherapy before are eligible for inclusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Gut Microbiota
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 14 Mar 2024to 31 Dec 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 300
Who may be able to join
- Age ≥ 18 years, gender not restricted;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-2, with -an expected survival period of more than 3 months;
- Metastatic or locally advanced gastric cancer confirmed by cytology or histopathology;
- Laboratory test data within 7 days before screening (including 7 days) should meet the following requirements: neutrophil count ≥ 1.5×109/L, platelet count ≥ 80×109/L, hemoglobin ≥ 80g/L, total serum bilirubin ≤ 1.5 times the upper limit of normal (ULN); ALT and AST ≤ 2.5 x ULN, if liver metastasis is present, ALT and AST ≤ 5 x ULN; albumin ≥ 30g/L; serum creatinine ≤ 1.5 x ULN or creatinine clearance rate (CCr) ≥ 60ml/min.
- At least one evaluable lesion (according to RECIST 1.1 criteria);
- No previous palliative chemotherapy and planned for first-line immunotherapy (nivolumab, sintilimab, tislelizumab, pembrolizumab as recommended by guidelines, specifically determined by the attending physician) combined with chemotherapy (FOLFOX, XELOX, SOX, specifically determined by the attending physician), and combination with fruquintinib is allowed (only for patients enrolled in the trial with the number HMPL-013-SH-GC103);
- The subject (or their legal representative/guardian) must sign the informed consent form, indicating that they understand the purpose of this study, are aware of the necessary procedures, and are willing to participate in this study.
Who cannot join
- Pregnant or lactating women, and women of childbearing age who have not taken adequate contraceptive measures;
- Patients with a history of other malignant tumors within 5 years, except for those with a history of cured cervical carcinoma in situ or non-melanoma skin cancer; Patients with primary brain tumors or central nervous system metastases that are not under control, and those with obvious intracranial hypertension or neuropsychiatric symptoms;
- Patients with the following severe or uncontrolled diseases: severe heart disease, unstable condition despite treatment, myocardial infarction, congestive heart failure, unstable angina pectoris, significant pericardial effusion or unstable arrhythmia within 6 months before enrollment; definite neurological or psychiatric disorders, including dementia or epileptic seizures; severe or uncontrolled infections; active disseminated intravascular coagulation, or patients with obvious bleeding tendencies;
- Patients with significant damage to important organs;
- Patients with pleural effusion or ascites causing respiratory syndrome (≥CTCAE grade 2 dyspnea) requiring local treatment;
- Other conditions where the investigator deems the patient unsuitable for participation in this trial;
- Patients who have been taking probiotics or antibiotics for a long time.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Wanjing Feng, +86 021-64175590, 1915659989@qq.com
About this study
Official title: A Study on the Assessment of the Efficacy of PD-1 Monoclonal Antibody Combined With Chemotherapy in Metastatic Gastric Cancer Based on Gut Microbiota
This study is designed as a single-center, open-label, phase II exploratory trial. Patients with advanced or locally advanced gastric cancer who have not received chemotherapy or immunotherapy before are eligible for inclusion. They will receive a first-line two-drug combination chemotherapy regimen (FOLFOX, XELOX, or SOX, determined by the attending physician) in combination with a PD-1 monoclonal antibody (nivolumab, sintilimab, tislelizumab, or pembrolizumab, determined by the attending physician). Fruquintinib can be added on this basis (only for patients enrolled in the HMPL-013-SH-GC103 study). The aim is to evaluate whether the gut microbiota has a predictive role in the efficacy of immunotherapy combined with chemotherapy for metastatic gastric cancer. A total of 100 patients will be enrolled in the study.
Gut microbiota will be measured at the following three time points:
- Within 3 days before the first chemotherapy (designated as time 0)
- Within 3 days before the third chemotherapy (designated as time 1)
- After the sixth chemotherapy cycle, or within 1 week after disease progression if it occurs within the sixth cycle (designated as time 2)
- Conditions
- Gastric Cancer, Gut Microbiota
- Being tested
- Observational study, no intervention
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study, no interventionOther
Observational study, no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
The gut microbiota predicts progression-free survival (PFS)
The gut microbiota predicts progression-free survival (PFS)
Measured: the duration from the date of randomization to any documented tumor progression or death due to any cause，assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start14 Mar 2024
- Primary completion14 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaodong Zhu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400354
- Sponsor's protocol ID
- MGC-FLORA
- Status last verified
- Feb 2026
- First submitted
- 25 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We would like to share data if request.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Assessment of the Efficacy of PD-1 Monoclonal Antibody Combined With Chemotherapy in Metastatic Gastric Cancer Based on Gut Microbiota
- ClinicalTrials.gov ID
- NCT07400354
- Acronym / sponsor ID
- MGC-FLORA
- Conditions
- Gastric Cancer, Gut Microbiota
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- 14 Mar 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Feb 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 study is designed as a single-center, open-label, phase II exploratory trial. Patients with advanced or locally advanced gastric cancer who have not received chemotherapy or immunotherapy before are eligible for inclusion. They will receive a first-line two-drug combination chemotherapy regimen (FOLFOX, XELOX, or SOX, determined by the attending physician) in combination with a PD-1 monoclonal antibody (nivolumab, sintilimab, tislelizumab, or pembrolizumab, determined by the attending physician). Fruquintinib can be added on this basis (only for patients enrolled in the HMPL-013-SH-GC103 study). The aim is to evaluate whether the gut microbiota has a predictive role in the efficacy of immunotherapy combined with chemotherapy for metastatic gastric cancer. A total of 100 patients will be enrolled in the study.
Gut microbiota will be measured at the following three time points:
- Within 3 days before the first chemotherapy (designated as time 0)
- Within 3 days before the third chemotherapy (designated as time 1)
- After the sixth chemotherapy cycle, or within 1 week after disease progression if it occurs within the sixth cycle (designated as time 2)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 300
Key inclusion criteria (7 listed)
- Age ≥ 18 years, gender not restricted;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-2, with -an expected survival period of more than 3 months;
- Metastatic or locally advanced gastric cancer confirmed by cytology or histopathology;
- Laboratory test data within 7 days before screening (including 7 days) should meet the following requirements: neutrophil count ≥ 1.5×109/L, platelet count ≥ 80×109/L, hemoglobin ≥ 80g/L, total serum bilirubin ≤ 1.5 times the upper limit of normal (ULN); ALT and AST ≤ 2.5 x ULN, if liver metastasis is present, ALT and AST ≤ 5 x ULN; albumin ≥ 30g/L; serum creatinine ≤ 1.5 x ULN or creatinine clearance rate (CCr) ≥ 60ml/min.
- At least one evaluable lesion (according to RECIST 1.1 criteria);
Key exclusion criteria (7 listed)
- Pregnant or lactating women, and women of childbearing age who have not taken adequate contraceptive measures;
- Patients with a history of other malignant tumors within 5 years, except for those with a history of cured cervical carcinoma in situ or non-melanoma skin cancer; Patients with primary brain tumors or central nervous system metastases that are not under control, and those with obvious intracranial hypertension or neuropsychiatric symptoms;
- Patients with the following severe or uncontrolled diseases: severe heart disease, unstable condition despite treatment, myocardial infarction, congestive heart failure, unstable angina pectoris, significant pericardial effusion or unstable arrhythmia within 6 months before enrollment; definite neurological or psychiatric disorders, including dementia or epileptic seizures; severe or uncontrolled infections; active disseminated intravascular coagulation, or patients with obvious bleeding tendencies;
- Patients with significant damage to important organs;
- Patients with pleural effusion or ascites causing respiratory syndrome (≥CTCAE grade 2 dyspnea) requiring local treatment;
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 |
|---|---|---|
| Observational study, no interventionObservational study, no intervention | Other | – |
Primary outcome
The gut microbiota predicts progression-free survival (PFS)
Time frame: the duration from the date of randomization to any documented tumor progression or death due to any cause，assessed up to 36 months
The gut microbiota predicts progression-free survival (PFS)
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 10 Feb 2026.
- Individual participant dataSharing planned: Undecided. We would like to share data if request.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Gut Microbiota, run by Fudan 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 7 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 10 Feb 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 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The gut microbiota predicts progression-free survival (PFS) (time frame: the duration from the date of randomization to any documented tumor progression or death due to any cause，assessed up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.