Could cutting one amino acid help fight stomach cancer?
NCT ID NCT07537348
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a 3-day low-leucine diet can make chemotherapy and immunotherapy work better for people with advanced stomach cancer. Researchers believe the diet may activate immune cells in the tumor. The trial involves 73 participants and will measure tumor shrinkage and survival rates.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- leucine-restricted diet
- What this could lead to
- If it works, this diet could boost the effectiveness of standard cancer treatments, potentially improving survival rates for people with advanced gastric cancer.
- What could go wrong
- This is a small, early-phase trial with only 73 participants. The diet is short-term and may not be feasible for all patients. It is not a cure, and the benefits are uncertain.
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.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 73 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Dec 2028
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.
- Ages
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18 to 70 years
- 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: * Diagnosis and Treatment Plan: Patients with advanced gastric cancer with distant metastasis, confirmed by imaging modalities (such as CT or PET-CT) and clinical pathological data, who are indicated for combined chemotherapy and immunotherapy. * Demographics: Aged 18 to 70 years, regardless of gender. * Dietary Capability: Capable of oral intake or receiving liquid diet via nasogastric tube. * Consent: Willing to participate in this study and have signed the Informed Consent Form (ICF). * Exclusion of Other Malignancies: No concurrent primary malignant tumors other than gastric cancer. Exclusion Criteria: * Cognitive or Psychiatric Impairment: Cognitive dysfunction or psychiatric disorders that prevent the patient from understanding the study content or providing informed consent. * Diabetes Mellitus: Diagnosis of Type 1 or Type 2 diabetes mellitus. * Gastrointestinal Conditions: Presence of severe diarrhea, intractable vomiting, severe malabsorption syndrome, paralytic or mechanical intestinal obstruction, or active gastrointestinal bleeding. * Allergy:Known hypersensitivity or allergy to any of the main components of the leucine-deficient nutritional powder. * Concomitant Supplements: Current use of other nutritional supplements that may potentially confound the study results or affect efficacy evaluation. * Treatment Tolerance: Inability to tolerate combined chemotherapy and immunotherapy, or occurrence of severe gastrointestinal adverse events following such treatment.
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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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Qilu Hospital of Shandong University
RECRUITINGJinan, Shandong, 250012, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can PET scans reveal which stomach cancers will respond to immunotherapy?
- Can a direct hit to tumors make immunotherapy work better?
- Can a Two-Pronged immune attack outsmart stomach cancer?
- Acupuncture with a jolt: could needles shield nerves from chemo?
- Real-World check: does adding nivolumab to chemo help stomach cancer patients?
- Fasting during immunotherapy: a new way to boost treatment?