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