[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"leucine-restricted-diet\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:leucine-restricted-diet":46},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100634259",false,"NCT07537361","Safety and Efficacy of Leucine-Restricted Diet Combined With Neoadjuvant Chemotherapy and Immunotherapy in Gastric Cancer","A Study on the Safety and Efficacy of Leucine-Restricted Diet in Gastric Cancer Patients Treated With Neoadjuvant Chemotherapy and Immunotherapy","LUCENT-GC-02","Inclusion Criteria:\n\n* Pathological Confirmation: Histologically confirmed locally advanced gastric cancer.\n* Demographics: Aged 18 to 70 years, inclusive, regardless of gender.\n* Dietary Capability: Capable of oral intake or receiving a liquid diet via nasogastric tube.\n* Consent: Willing to participate in the study and have signed the Written Informed Consent Form (ICF).\n* Staging and Treatment Indication: No evidence of distant metastasis on imaging examinations (such as CT or PET-CT), with a clinical stage of locally advanced gastric cancer, indicating the need for neoadjuvant chemo-immunotherapy prior to surgery.\n* Exclusion of Other Malignancies: No concurrent primary malignant tumors other than gastric cancer.\n\nExclusion Criteria:\n\n* Cognitive or Psychiatric Impairment: Cognitive dysfunction or psychiatric disorders severe enough to prevent the patient from understanding the study content or providing informed consent.\n* Diabetes Mellitus: Diagnosis of Type 1 or Type 2 diabetes mellitus.\n* Gastrointestinal Conditions: Presence of severe diarrhea, intractable vomiting, severe malabsorption syndrome, paralytic or mechanical intestinal obstruction, or active gastrointestinal bleeding.\n* Allergy\u002FHypersensitivity: Known hypersensitivity or allergy to any of the main components of the leucine-deficient nutritional powder.\n* Concomitant Supplements: Current use of other nutritional supplements that may potentially confound the study results or affect the evaluation of efficacy.\n* Treatment Tolerance: Inability to tolerate neoadjuvant chemo-immunotherapy, or occurrence of severe gastrointestinal adverse events following such treatment.\n* Pathological Diagnosis: Postoperative pathological diagnosis confirming non-primary gastric cancer (e.g., metastatic tumors from other origins).","ALL","18 Years","70 Years",{"count":20,"type":21},108,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Consistent with previous literature, the investigators postulate that a leucine-restricted diet is safe and well-tolerated in gastric cancer patients receiving neoadjuvant chemo-immunotherapy. Furthermore, the investigators propose that this dietary regimen promotes the activation of immune cells within the tumor microenvironment (TME). When combined with neoadjuvant chemo-immunotherapy, it demonstrates synergistic anti-tumor efficacy, thereby improving patient prognosis.",[27,28],"Gastric Cancer","Leucine-restricted Diet",[30,31,32,33],"gastric cancer","leucine-restricted diet","Neoadjuvant Therapy","immunotherapy","RECRUITING","2026-04-15",{"date":37,"type":38},"2026-04-17","ACTUAL",{"date":40,"type":38},"2026-01-01",{"date":42,"type":21},"2027-08-31",{"name":44,"class":45},"Qilu Hospital of Shandong University","OTHER",""]