[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634259":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":37,"studyPopulation":33,"armGroups":43,"interventions":54,"overallOfficials":33,"centralContacts":60,"locations":66,"responsibleParty":82,"collaborators":33,"id":84,"slug":33,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":33,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":104,"overallStatus":68,"whyStopped":33,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Qilu Hospital of Shandong University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":24,"otherOutcomes":33},[9,13,16,20],{"measure":10,"description":11,"timeFrame":12},"Response Evaluation Criteria in Solid Tumors (RECIST) Grade","This scoring system includes four grades: CR, PR, PD, and SD, where CR stands for complete response, PR for partial response, PD for progressive disease, and SD for stable disease.","1 year after surgery",{"measure":14,"description":15,"timeFrame":12},"1-year survival rate and overall survival (OS)","This indicator is calculated by comprehensively summarizing the 1-year survival rate and overall survival.",{"measure":17,"description":18,"timeFrame":19},"The tumor regression grade (TRG) system","TRG (Tumor Regression Grade) is used to assess pathological response after neoadjuvant therapy based on the 8th edition AJCC\u002FCAP criteria. Different grades represent varying degrees of regression: TRG 0 indicates complete response (no residual tumor cells); TRG 1 indicates near-complete response (scattered residual tumor cells, \\\u003C10%); TRG 2 indicates partial response (residual tumor cells accounting for 10%-50%); TRG 3 indicates no or minimal response (residual tumor cells \\>50%). Higher grades suggest poorer treatment efficacy.","1 month after surgery",{"measure":21,"description":22,"timeFrame":23},"Grade of CTCAE grading system","The CTCAE grading system comprises five grades (1-5). Grade 1 represents no or mild symptoms, while Grade 5 indicates death.","6 months after surgery",[25,29],{"measure":26,"description":27,"timeFrame":28},"Serum amino acid concentrations in patients","Following leucine-restricted diet intervention, peripheral venous blood was collected from gastric cancer patients to measure serum concentrations of various amino acids, including leucine.","Measurements were performed prior to the initiation of the amino acid-restricted diet and on the day of surgery before the operation.",{"measure":30,"description":31,"timeFrame":32},"Changes in the Immune Microenvironment","Tumor single-cell RNA sequencing (scRNA-seq) and circulating tumor DNA (ctDNA) data were compared before and after the dietary intervention. Additionally, peripheral blood samples were collected for flow cytometric analysis of CD8+ T cells and ctDNA quantification.","Measurements were performed prior to the initiation of the amino acid-restricted diet and on the day of surgery before the operation",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":37,"primaryPurpose":38,"observationalModel":33,"timePerspective":33,"maskingInfo":39},"RANDOMIZED","PARALLEL","In this study, participants were divided into an intervention group and a control group. Both groups received four cycles of neoadjuvant therapy comprising Oxaliplatin, S-1, and the PD-1 inhibitor Sintilimab. The intervention group implemented a 3-day leucine-restricted diet during each cycle, gradually resuming a normal diet thereafter, whereas the control group maintained a standard normal diet throughout the treatment period. This design was established to evaluate the safety and efficacy of the leucine-restricted diet in the context of neoadjuvant chemo-immunotherapy for gastric cancer.","TREATMENT",{"masking":40,"maskingDescription":33,"whoMasked":41},"SINGLE",[42],"PARTICIPANT",[44,50],{"label":45,"type":46,"description":47,"interventionNames":48},"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.",[49],"Dietary Supplement: Leucine-restricted diet",{"label":51,"type":52,"description":53,"interventionNames":33},"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.",[55],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":33},"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.",[45],[61],{"name":62,"role":63,"phone":64,"phoneExt":33,"email":65},"Hui Qu, Doctor of Medicine","CONTACT","+86-18560085120","doctorquhui@email.sdu.edu.cn",[67],{"facility":5,"status":68,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"RECRUITING","Jinan","Shandong","250012","China","CN",{"type":75,"coordinates":76},"Point",[77,78],116.99722,36.66833,{"lat":78,"lon":77},[81],{"name":62,"role":63,"phone":64,"phoneExt":33,"email":65},{"type":83,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","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":95,"type":96},108,"ESTIMATED","INTERVENTIONAL",[99],"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.",[102,103],"Gastric Cancer","Leucine-restricted Diet",[105,106,107,108],"gastric cancer","leucine-restricted diet","Neoadjuvant Therapy","immunotherapy","2026-04-15",{"date":111,"type":112},"2026-04-17","ACTUAL",{"date":114,"type":112},"2026-01-01",{"date":116,"type":96},"2027-08-31",{"name":5,"class":6},1]