[{"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":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100634259","phase-2-safety-and-efficacy-of-leucine-restricted-diet-combined-with-neoadjuvant-chemotherapy-and-immunotherapy-in-gastric-cancer-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":21,"type":22},108,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29],"Gastric Cancer","Leucine-restricted Diet",[31,32,33,34],"gastric cancer","leucine-restricted diet","Neoadjuvant Therapy","immunotherapy","RECRUITING","2026-04-15",{"date":38,"type":39},"2026-04-17","ACTUAL",{"date":41,"type":39},"2026-01-01",{"date":43,"type":22},"2027-08-31",{"name":45,"class":46},"Qilu Hospital of Shandong University","OTHER"]