Gut bugs may hold key to stomach cancer treatment success
NCT ID NCT07400354
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is looking at whether the bacteria in your gut can predict how well a combination of immunotherapy and chemotherapy works for advanced stomach cancer. Researchers will track 300 patients and check their gut bacteria at several points during treatment. The goal is to find a way to personalize treatment based on each person's unique gut microbiome.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could help doctors predict which patients with metastatic gastric cancer will benefit most from combining immunotherapy with chemotherapy, leading to more personalized treatment.
- What could go wrong
- This is an early exploratory study, not a treatment trial. It aims to find a predictive marker, not to test a new cure. The results may not change practice immediately.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
300
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fudan University Shanghai Cancer Center
RECRUITINGShanghai, Shanghai Municipality, 200032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Could gut bacteria predict lung trouble after surgery?
- Robotic surgery vs standard approaches: does the platform change cancer outcomes?
- New drug trio takes aim at HER2-Positive stomach cancer
- Can a direct hit to tumors make immunotherapy work better?