[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634259":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":31,"responsibleParty":47,"collaborators":18,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":18,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":33,"whyStopped":18,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Qilu Hospital of Shandong University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Leucine-restricted Group","EXPERIMENTAL","Patients received four cycles of neoadjuvant therapy consisting of chemotherapy (Oxaliplatin plus S-1) combined with the PD-1 inhibitor Sintilimab. During each cycle, patients adhered to a leucine-restricted diet for 3 days. Following this 3-day period, the dietary intervention was discontinued, and patients gradually resumed a normal diet until the next cycle.",[13],"Dietary Supplement: Leucine-restricted diet",{"label":15,"type":16,"description":17,"interventionNames":18},"Normal diet Group","NO_INTERVENTION","Patients in the control group underwent four cycles of neoadjuvant chemo-immunotherapy (Oxaliplatin, S-1, and Sintilimab) but adhered to a conventional normal diet throughout the entire treatment period.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DIETARY_SUPPLEMENT","Leucine-restricted diet","Patients received a total of four cycles of neoadjuvant therapy.During each treatment cycle, patients adhered to a leucine-restricted diet for 3 days. After this 3-day period, the dietary intervention was stopped, and patients gradually resumed a normal diet for the remainder of the cycle.",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Hui Qu, Doctor of Medicine","CONTACT","+86-18560085120","doctorquhui@email.sdu.edu.cn",[32],{"facility":5,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"RECRUITING","Jinan","Shandong","250012","China","CN",{"type":40,"coordinates":41},"Point",[42,43],116.99722,36.66833,{"lat":43,"lon":42},[46],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},{"type":48,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","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":61,"type":62},108,"ESTIMATED","INTERVENTIONAL",[65],"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.",[68,69],"Gastric Cancer","Leucine-restricted Diet",[71,72,73,74],"gastric cancer","leucine-restricted diet","Neoadjuvant Therapy","immunotherapy","2026-04-15",{"date":77,"type":78},"2026-04-17","ACTUAL",{"date":80,"type":78},"2026-01-01",{"date":82,"type":62},"2027-08-31",{"name":5,"class":6},1]