protocolSection identificationModule nctId: NCT06389760, orgStudyIdInfo id: IST-Nim-PC-16, briefTitle: Single-arm Study of Nimotuzumab Combined With mFOLFIRNIOX as Postoperative Adjuvant Therapy in Pancreatic Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-18, primaryCompletionDateStruct date: 2026-09-30, completionDateStruct date: 2026-09-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, class: OTHER, descriptionModule briefSummary: This is a prospective, multicenter, single-arm, phase II trial. The main purpose of the study is to evaluate the efficacy and safety of Nimotuzumab combined with mFOLFIRINOX for postoperative adjuvant treatment of pancreatic cancer., conditionsModule conditions: Pancreatic Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Nimotuzumab, interventions name: mFOLFIRINOX, outcomesModule primaryOutcomes measure: disease-free survival (DFS), secondaryOutcomes measure: distant metastasis-free survival (DMFS), secondaryOutcomes measure: overall survival (OS), secondaryOutcomes measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30), secondaryOutcomes measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire pancreatic cancer 29 (EORTC-QLQ-PAN26), secondaryOutcomes measure: tumor-related markers, secondaryOutcomes measure: adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210008, country: China, contacts name: Juan Du, M.D. Ph.D, role: CONTACT, phone: +86-025-83106666, email: dujunglyy@163.com, contacts name: Juan Du, M.D. Ph.D, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False