Safety and Efficacy of TareSphere in Patients With Unresectable Hepatocellular Carcinoma

NCT06310590 | Completed Phase 1

• 2 other identifiers: NRT6003-HCC-2022CTR20230515
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 10

Brief Summary

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

Keywords

Selective internal radiation therapy; Yttrium-90; Transarterial Radioembolization;

Outcome Measures

Primary Outcomes (2)

• Adverse events/ Severe adverse events

  Occurrence of adverse events/severe adverse events

  Up to 12 months

• Localized Objective response rates (ORR)

  Liver target lesions, evaluated based on the mRECIST criteria

  Up to 6 months (initial tumor assessment after administration)

Secondary Outcomes (10)

• Hepatic time to progression (hTTP)

  Up to 12 months

• Duration of response (DOR)

  Up to 12 months

• Disease control rate (DCR)

  Up to 12 months

• Time to progression (TTP)

  Up to 12 months

• Progression Free Survival (PFS)

  Up to 12 months

Study Arms (1)

NRT6003 Injection

EXPERIMENTAL

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).

Drug: NRT6003 Injection

Interventions

NRT6003 Injection DRUG

Selective internal radiation therapy (SIRT) with TareSphere

Also known as: Yttrium-90 carbon microspheres

NRT6003 Injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 80 and signed informed consent;
• Diagnosed as hepatocellular carcinoma clinically, by imaging and/or pathology based on the guideline of the National Health Commission of the People's Republic of China (2022);
• Evaluated by the investigator as not suitable for surgical resection/ablation, or there are other reasons unsuitable for surgical resection/ablation, or the participant refuses surgical resection/ablation;
• At least one well defined tumor (mRECIST), assessed by enhanced MRI or CT images;
• Child-Pugh score ≤ 7;
• Eastern Cooperative Oncology Group performance status ≤ 1;
• Tumor burden ≤ 50 percent of the total liver volume;
• Adequate organ function: (1) Blood routine \[no blood transfusion or granulocyte colony-stimulating factor (G-CSF) treatment within 14 days\]: absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L; platelet (PLT) ≥ 80 × 10\^9/L; hemoglobin (HGB) ≥ 90 g/L; (2) Liver function: total bilirubin (TBIL) ≤ 2 times upper limit of normal (ULN); alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 5. 0×ULN; Albumin \> 30 g/L; (3) Renal function: Creatinine (Cr) ≤ 1.5×ULN; creatinine clearance rate (CCr)≥ 50 mL/min (calculated according to Cockcroft-Gault formula); (4) Coagulation function: international normalized ratio (INR), prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤1.5×ULN \[If any participant takes warfarin or heparin for anticoagulation therapy, the investigator should evaluate whether the participant meet the requirements of the protocol\]; (5) Cardiovascular function: left ventricular ejection fraction (LVEF) ≥ 50 percent assessed by ultrasonic cardiogram;
• Women and men of childbearing age must agree to take strict and effective contraceptive measures during the study period and within 6 months after the end of the trial. Men are forbidden to donate sperm. The pregnancy test results of female participants of childbearing age during the screening period and within 24 hours before administration must be negative.

You may not qualify if:

• With the extrahepatic metastasis or concurrent malignant tumors other than liver cancer;
• With the hepatic tumor thrombus (excluding the thrombus limited to liver segments or lobes);
• With hepatic artery malformation and unable to intubate hepatic artery;
• Allergy to contrast agents or anesthetics;
• Severe pulmonary dysfunction (forced expiratory volume in one second, FEV1/FVC \< 50 percent or forced expiratory volume in one second (FEV1) \< 50 percent of predicted value, or maximum voluntary ventilation (MVV) \< 50 L/min);
• With the clinical manifestations of decompensated liver cirrhosis (moderate or severe ascites, upper gastrointestinal bleeding, hepatic encephalopathy, etc.);
• With diseases have not been controlled despite aggressive treatment, and which may affect the safety or the efficacy of the investigational drug in the judgement of investigators;
• Active or severely infected participants requiring systemic therapy;
• With positive results of HIV antibody test;
• Estimated survival period \< 3 months;
• Have received radiotherapy or transcatheter arterial chemoembolization (participants who have received transcatheter arterial non-iodized oil chemoembolization are judged by investigators);
• Technetium (99mTc)-macroaggregated albumin (MAA) hepatic arterial perfusion imaging estimates that the NRT6003 injection cannot cover all lesions within the liver (excluding lesions previously treated by the investigator as non-active or non-progressive);
• Hepatic artery angiography and 99mTc-MAA hepatic artery perfusion imaging demonstrate gastrointestinal shunts, which may not be remedied through vascular intervention techniques;
• mTc-MAA arterial perfusion imaging shows that the single lung radiation absorbed dose \> 30 Gy;
• Received antitumor therapy or participated in other interventional clinical trials within 30 days prior to dosing;

Sponsors & Collaborators

• Chengdu New Radiomedicine Technology Co. LTD.: lead

Study Sites (10)

Anhui Provincial Hospital

Hefei, Anhui, China

Location

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

Hunan Provincial People's Hospital

Changsha, Hunan, China

Location

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Location

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Location

Zhongshan Hospital, Fudan University

Shanghai, China

Location

Study Officials

• Gaojun Teng, MD

  Zhongda Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 15, 2024
• Study Start: August 8, 2023
• Primary Completion: June 10, 2025
• Study Completion: June 10, 2025
• Last Updated: February 3, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (10)