protocolSection identificationModule nctId: NCT06310590, orgStudyIdInfo id: NRT6003-HCC-2022, secondaryIdInfos id: CTR20230515, type: OTHER, domain: Center for Drug Evaluation, NMPA, briefTitle: Safety and Efficacy of NRT6003 in Patients With Unresectable Hepatocellular Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-08, primaryCompletionDateStruct date: 2025-10-31, completionDateStruct date: 2025-10-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Chengdu New Radiomedicine Technology Co. LTD., class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the safety and efficacy of NRT6003 Injection in patients with unresectable HCC., conditionsModule conditions: Unresectable Hepatocellular Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: NRT6003 Injection, outcomesModule primaryOutcomes measure: Adverse events/ Severe adverse events, primaryOutcomes measure: Localized Objective response rates (ORR), secondaryOutcomes measure: Hepatic time to progression (hTTP), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Time to progression (TTP), secondaryOutcomes measure: Progression Free Survival (PFS), secondaryOutcomes measure: Concentration of Alpha fetoprotein (AFP), secondaryOutcomes measure: Quality of life (QoL), secondaryOutcomes measure: Yttrium-90 distribution, secondaryOutcomes measure: Resection rate of liver target lesions, secondaryOutcomes measure: Radioactivity of Yttrium-90 for 9 participants, assessed by liquid scintillation counter, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anhui Provincial Hospital, status: RECRUITING, city: Hefei, state: Anhui, country: China, contacts name: Lianxin Liu, role: CONTACT, contacts name: Lianxin Liu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.86389, lon: 117.28083, locations facility: Fujian Provincial Cancer Hospital, status: RECRUITING, city: Fuzhou, state: Fujian, country: China, contacts name: Hailan Lin, role: CONTACT, contacts name: Hailan Lin, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.06139, lon: 119.30611, locations facility: The First Affiliated Hospital of Xiamen University, status: RECRUITING, city: Xiamen, state: Fujian, country: China, contacts name: Jinxiong Huang, role: CONTACT, contacts name: Jinxiong Huang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 24.47979, lon: 118.08187, locations facility: The First Affiliated Hospital of Jinan University, status: RECRUITING, city: Guangzhou, state: Guangdong, country: China, contacts name: Hao Xu, role: CONTACT, contacts name: Hao Xu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, locations facility: Henan Cancer Hospital, status: RECRUITING, city: Zhengzhou, state: Henan, country: China, contacts name: Hailiang Li, role: CONTACT, contacts name: Hui Yang, role: CONTACT, contacts name: Hailiang Li, role: PRINCIPAL_INVESTIGATOR, contacts name: Hui Yang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Hunan Provincial People's Hospital, status: RECRUITING, city: Changsha, state: Hunan, country: China, contacts name: Hua Xiang, role: CONTACT, contacts name: Hua Xiang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Zhongda Hospital, Southeast University, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210009, country: China, contacts name: Gaojun Teng, MD, role: CONTACT, phone: +8602583272084, email: zdyyjgb@163.com, contacts name: Gaojun Teng, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.06167, lon: 118.77778, locations facility: The First Hospital of China Medical University, status: RECRUITING, city: Shenyang, state: Liaoning, country: China, contacts name: Haibo Shao, role: CONTACT, contacts name: Haibo Shao, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.79222, lon: 123.43278, locations facility: West China Hospital, Sichuan University, status: RECRUITING, city: Chengdu, state: Sichuan, country: China, contacts name: Hong Wu, role: CONTACT, contacts name: Hong Wu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.66667, lon: 104.06667, locations facility: The Affiliated Hospital of Southwest Medical University, status: RECRUITING, city: Luzhou, state: Sichuan, country: China, contacts name: Yue Chen, role: CONTACT, contacts name: Yue Chen, role: PRINCIPAL_INVESTIGATOR, locations facility: Zhejiang Cancer Hospital, status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310022, country: China, contacts name: Guoliang Shao, role: CONTACT, contacts name: Guoliang Shao, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.29365, lon: 120.16142, locations facility: The First Affiliated Hospital, Zhejiang University School of Medicine, status: RECRUITING, city: Hangzhou, state: Zhejiang, country: China, contacts name: Tingbo Liang, role: CONTACT, contacts name: Tingbo Liang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.29365, lon: 120.16142, locations facility: The First Affiliated Hospital of Wenzhou Medical University, status: RECRUITING, city: Wenzhou, state: Zhejiang, country: China, contacts name: Chang Yu, role: CONTACT, contacts name: Chang Yu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 27.99942, lon: 120.66682, locations facility: The Southwest Hospital of Army Medical University, status: RECRUITING, city: Chongqing, country: China, contacts name: Leida Zhang, role: CONTACT, contacts name: Leida Zhang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Fudan University Shanghai Cancer Center, status: RECRUITING, city: Shanghai, country: China, contacts name: Wentao Li, role: CONTACT, contacts name: Wentao Li, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, locations facility: The First Affiliated Hospital of Naval Medical University, status: RECRUITING, city: Shanghai, country: China, contacts name: Changjing Zuo, role: CONTACT, contacts name: Changjing Zuo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, locations facility: The Third Affiliated Hospital of Naval Medical University, status: RECRUITING, city: Shanghai, country: China, contacts name: Hui Liu, role: CONTACT, contacts name: Hui Liu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Zhongshan Hospital, Fudan University, status: RECRUITING, city: Shanghai, country: China, contacts name: Zhiping Yan, role: CONTACT, contacts name: Hongcheng Shi, role: CONTACT, contacts name: Zhiping Yan, role: PRINCIPAL_INVESTIGATOR, contacts name: Hongcheng Shi, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Tianjin Medical University Cancer Insititute & Hospital, status: RECRUITING, city: Tianjin, country: China, contacts name: Wei Lu, role: CONTACT, contacts name: Wei Lu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.14222, lon: 117.17667, hasResults: False