protocolSection identificationModule nctId: NCT06278454, orgStudyIdInfo id: NrtPac-1, secondaryIdInfos id: CTR20240312, type: OTHER, domain: Center for Drug Evaluation, NMPA, briefTitle: Safety and Efficacy of NRT6008 in Patients With Unresectable Locally Advanced Pancreatic Cancer (LAPC), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Chengdu New Radiomedicine Technology Co. LTD., class: INDUSTRY, descriptionModule briefSummary: This is a single arm, open label, multi-center phase I study, including phase Ia dose escalation and phase Ib dose expansion. Safety review committee (SRC) will be formed to monitor safety and efficacy data through the study. And the independent review committee (IRC) will be formed to monitor efficacy data through the study., conditionsModule conditions: Unresectable Pancreatic Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 58, type: ESTIMATED, armsInterventionsModule interventions name: NRT6008 Injection + Systematic chemotherapy, outcomesModule primaryOutcomes measure: Maximum tolerated dose (MTD) or the recommended phase Ⅱ dose (RP2D), primaryOutcomes measure: Dose-limiting toxicity (DLT), primaryOutcomes measure: Adverse events (AE) and severe adverse events (SAE), secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Resection rate (R0 and R1), otherOutcomes measure: Concentration of tumor biomarkers, otherOutcomes measure: Numeric rating scale (NRS) of pain, otherOutcomes measure: Distribution of NRT6008 injection in human body and radioactivity of biological samples, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Henan Cancer Hospital, city: Zhengzhou, state: Henan, country: China, contacts name: Suxia Luo, role: CONTACT, contacts name: Suxia Luo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Second Affiliated Hospital of Soochow University, city: Suzhou, state: Jiangsu, country: China, contacts name: Duanmin Hu, role: CONTACT, contacts name: Duanmin Hu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.30408, lon: 120.59538, locations facility: Shanghai Changhai Hospital, city: Shanghai, state: Shanghai, zip: +8602131162338, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Chongqing University Cancer Hospital, city: Chongqing, country: China, contacts name: Weiqing Chen, role: CONTACT, contacts name: Weiqing Chen, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Tianjin Medical University General Hospital, city: Tianjin, country: China, contacts name: Bangmao Wang, role: CONTACT, contacts name: Bangmao Wang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.14222, lon: 117.17667, hasResults: False