Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Patients will be administered a single dose of NRT6003 Injection, and then they will be assessed by SPECT-CT imaging within 24 hours for its distribution in the chest and upper abdomen, including extrahepatic shunts, intrahepatic distribution, and target lesion distribution as expected.

Nine Patients will be tested for the radioactivity of Yttrium-90 in blood, urine, and feces (if available).

Selective internal radiation therapy (SIRT) with Yttrium-90 carbon microspheres

NRT6003 Injection

Gaojun Teng

Lianxin Liu

Hailan Lin

Jinxiong Huang

Hao Xu

Hailiang Li

Hui Yang

Hua Xiang

Gaojun Teng, MD

Haibo Shao

Hong Wu

Yue Chen

Guoliang Shao

Tingbo Liang

Chang Yu

Leida Zhang

Wentao Li

Changjing Zuo

Hui Liu

Zhiping Yan

Hongcheng Shi

Wei Lu

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 Yttrium-90 carbon microspheres in patients with unresectable HCC remain 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.

Safety and Efficacy of NRT6003 in Patients With Unresectable Hepatocellular Carcinoma

Study on the Safety and Effectiveness of NRT6003 Injection in Patients With Unresectable Hepatocellular Carcinoma (HCC)

Relevant results will be selectively disclosed in the future.

Occurrence of adverse events/severe adverse events

Liver target lesions, evaluated based on the mRECIST criteria

Time to progression of liver target lesions, evaluated by the investigator and independent image review committee respectively (mRECIST)

Time without imaging progression, evaluated by the investigator and independent image review committee respectively (mRECIST)

Time with tumor progression, evaluated by the investigator and independent image review committee respectively (mRECIST)

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)

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)

Assessed by SPECT-CT imaging in the chest and upper abdomen, including extrahepatic shunts, intrahepatic distribution, and target lesion distribution as expected.

Detect the radioactivity of Yttrium-90 in blood, urine, and feces (if available) in liquid scintillation counter

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety and Efficacy of NRT6003 in Patients With Unresectable Hepatocellular Carcinoma	NCT06310590	Unresectable He...	NRT6003 Injecti...	18 Years - 80 Years	Chengdu New Radiomedicine Technology Co. LTD.
Safety and Efficacy of NRT6003 in Patients With Unresectable Hepatocellular Carcinoma	NCT06310590	Unresectable He...	NRT6003 Injecti...	18 Years - 80 Years	Chengdu New Radiomedicine Technology Co. LTD.

Spots Global Cancer Trial Database for nrt6003 injection