protocolSection identificationModule nctId: NCT06338683, orgStudyIdInfo id: QRCH-2024001, briefTitle: Survival With Olanzapine in Patients With Locally Advanced or Metastatic Upper Gastrointestinal and Lung Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2027-03-20, completionDateStruct date: 2028-03-20, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Qinghai Red Cross Hospital, class: OTHER, descriptionModule briefSummary: This study aims to assess the impact of adding olanzapine to nutritional advice and standard anti-tumor therapy on the survival and safety of patients with locally advanced, unresectable or metastatic gastric cancer, esophageal cancer, hepato-pancreaticobiliary cancer, and lung cancer. Researchers seek to determine whether olanzapine can improve progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) in advanced cancer patients who received standard anti-tumor therapy, and investigate the relationship between olanzapine-induced weight changes and patient survival., conditionsModule conditions: Advanced Cancer, conditions: Olanzapine, conditions: Progression Free Survival, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 230, type: ESTIMATED, armsInterventionsModule interventions name: Olanzapine 2.5 MG, interventions name: Standard anti-tumor treatment, interventions name: Nutritional advice, outcomesModule primaryOutcomes measure: Comparing the difference in Median PFS between the two groups, secondaryOutcomes measure: Comparing the difference in Median OS between the two groups, secondaryOutcomes measure: Comparing the difference in ORR between the two groups, secondaryOutcomes measure: Comparing the difference in the incidence of ≥3% weight loss between the two groups, secondaryOutcomes measure: Comparing the difference in BMI between the two groups, secondaryOutcomes measure: Comparing the difference in the improvement in other symptoms (appetite, nausea, fatigue, insomnia) between the two groups, secondaryOutcomes measure: Comparing the difference in Quality of life in the overall stage between the two groups, secondaryOutcomes measure: neutrophil-to-lymphocyte ratio, secondaryOutcomes measure: platelet-to-lymphocyte ratio, secondaryOutcomes measure: C-reactive protein (CRP) concentration, secondaryOutcomes measure: concentration of albumin, secondaryOutcomes measure: Level of interleukin (IL)-6 and IL-8, secondaryOutcomes measure: Comparing the difference in the side effects of olanzapine treatment between the two groups, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Qinghai Red Cross Hospital, status: RECRUITING, city: Xining, state: Qinghai, zip: 810000, country: China, contacts name: Qiuxia Dong, Dr, role: CONTACT, phone: 0971-8267613, email: 2816278916@qq.com, geoPoint lat: 36.62554, lon: 101.75739, hasResults: False