The goal of this clinical trial is to evaluate the safety and efficacy of NRT6003 Injection in patients with unresectable HCC.
The efficacy and safety of TareSphere in patients with unresectable HCC remains unknown. This trial is a prospective, multicenter, open-label, single-arm phase I trial designed to evaluate the safety and efficacy of NRT6003 injection. The primary objective is to evaluate the safety of NRT6003 Injection. While the secondary objectives include the assessments of the antitumoral efficacy, the improvement of patients´ quality of life, and the distribution characteristics of Yttrium-90 in body.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Selective internal radiation therapy (SIRT) with TareSphere
Anhui Provincial Hospital
Hefei, Anhui, China
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Adverse events/ Severe adverse events
Occurrence of adverse events/severe adverse events
Time frame: Up to 12 months
Localized Objective response rates (ORR)
Liver target lesions, evaluated based on the mRECIST criteria
Time frame: Up to 6 months (initial tumor assessment after administration)
Hepatic time to progression (hTTP)
Time to progression of liver target lesions, evaluated by the investigator and independent image review committee respectively (mRECIST)
Time frame: Up to 12 months
Duration of response (DOR)
Time without imaging progression, evaluated by the investigator and independent image review committee respectively (mRECIST)
Time frame: Up to 12 months
Disease control rate (DCR)
Time without imaging progression, evaluated by the investigator and independent image review committee respectively (mRECIST)
Time frame: Up to 12 months
Time to progression (TTP)
Time with tumor progression, evaluated by the investigator and independent image review committee respectively (mRECIST)
Time frame: Up to 12 months
Progression Free Survival (PFS)
Duration from the administration to the first evidence of progression or death from any cause, evaluated by the investigator and independent image review committee respectively (mRECIST)
Time frame: Up to 12 months
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Hunan Provincial People's Hospital
Changsha, Hunan, China
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Zhongshan Hospital, Fudan University
Shanghai, China
Concentration of Alpha fetoprotein (AFP)
The variation of AFP levels
Time frame: Up to 12 months
Quality of life (QoL)
The variation of QoL with the EORTC (European organization for Research and Treatment of Cancer) QLG (Quality of Life Group) Core Questionnaire (EORTC QLQ-C30)
Time frame: Up to 12 months
Yttrium-90 distribution
Assessed by SPECT-CT imaging in the chest and upper abdomen, including extrahepatic shunts, intrahepatic distribution, and target lesion distribution as expected.
Time frame: Within 24 hours
Resection rate of liver target lesions
Resection rate of liver target lesions
Time frame: Within 6 months after administration
Radioactivity of Yttrium-90 for 9 participants, assessed by liquid scintillation counter
Detect the radioactivity of Yttrium-90 in blood, urine, and feces (if available) in liquid scintillation counter
Time frame: Within 168 hours