Yttrium-90 Carbon Microsphere Radioembolization in Previously Treated Hepatocellular Carcinoma

A Prospective, Open-Label, Investigator-Initiated Study to Evaluate the Safety and Efficacy of NRT6003 Injection (Yttrium-90 Carbon Microspheres) Radioembolization in Previously Treated Patients With Hepatocellular Carcinoma

This is a prospective, open-label, single-arm, investigator-initiated study designed to evaluate the safety and efficacy of NRT6003 Injection, a yttrium-90 carbon microsphere product, administered by selective internal radiation therapy in previously treated patients with hepatocellular carcinoma.

Eligible participants will undergo protocol-specified screening assessments, hepatic vascular evaluation, 99mTc-MAA hepatic arterial perfusion imaging, and dosimetry assessment before treatment. Participants who meet the eligibility criteria and are considered suitable for selective internal radiation therapy will receive a single transarterial administration of NRT6003 Injection. Safety follow-up will be conducted for 12 months after treatment, and tumor response will be assessed using mRECIST and RECIST v1.1.

Study Overview

• Status: Not yet recruiting
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Drug: NRT6003 Injection

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jingjun Huang, MD; Phone Number: +86-20-34156205; Email: junooi@foxmail.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510260
      • The Second Affiliated Hospital, Guangzhou Medical University
      • Contact: Jingjun Huang, MD; Phone Number: +86-20-34156205; Email: junooi@foxmail.com
      • Principal Investigator: Kangshun Zhu, MD
      • Sub-Investigator: Jingjun Huang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18 years or older, male or female, with body weight greater than 30 kg. 2. Clinically, radiologically, and/or pathologically diagnosed hepatocellular carcinoma. 3. Previously treated with TACE, and/or HAIC, and considered by the investigator to be able to tolerate yttrium-90 carbon microsphere radioembolization. 4. Child-Pugh score ≤7, ECOG performance status <2, and life expectancy >3 months. 5. Disease confined to the liver after systemic assessment. 6. At least one measurable lesion according to mRECIST and RECIST v1.1. 7. Adequate residual normal liver volume and adequate bone marrow, hepatic, renal, and coagulation function. 8. For participants with portal vein tumor thrombus, eligibility must be confirmed by the investigator based on hepatic angiography and 99mTc-MAA hepatic arterial perfusion imaging. 9. Suitable for SIRT based on hepatic vascular evaluation and 99mTc-MAA assessment. 10. Willing to use effective contraception as required by the protocol. 11. Able to understand and comply with the study requirements and willing to provide written informed consent.

Exclusion Criteria:

1. Extrahepatic metastasis, including regional lymph node metastasis. 2. Uncontrolled biliary obstruction or recent biliary infection within 6 months before informed consent. 3. Prior internal or external radiotherapy to the liver or upper abdomen. 4. Anticancer therapy within 30 days before NRT6003 treatment, or small-molecule targeted therapy within 14 days before treatment. 5. Known allergy, intolerance, or contraindication to any study-related drug, contrast agent, anesthetic agent, or excipient. 6. Severe pulmonary dysfunction. 7. Untreated or inadequately treated esophageal or gastric varices considered by the investigator to have a high bleeding risk. 8. Uncontrolled disease or infection that may affect study safety or efficacy, as judged by the investigator. 9. Positive HIV antibody test. 10. 99mTc-MAA imaging or hepatic angiography showing inadequate coverage of target intrahepatic lesions, uncorrectable gastrointestinal shunting, or estimated single-session lung absorbed dose >30 Gy. 11. Pregnant or breastfeeding women. 12. Any other condition that, in the investigator's opinion, makes the participant unsuitable for this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: NRT6003 Injection Radioembolization; Participants will receive one session of transarterial selective internal radiation therapy with NRT6003 Injection, a yttrium-90 carbon microsphere product, after hepatic vascular evaluation, 99mTc-MAA simulation, and individualized dosimetry assessment.

Drug: NRT6003 Injection; NRT6003 Injection contains yttrium-90 carbon microspheres and is administered by transarterial infusion for selective internal radiation therapy. Participants will receive one treatment session only. The administered activity will be determined based on hepatic vascular assessment, 99mTc-MAA simulation, lung shunting assessment, and individualized dosimetry.; Other Names: TARE; SIRT; Selective Internal Radiation Therapy; Transarterial Radioembolization; Yttrium-90 Carbon Microspheres; Y-90 Carbon Microspheres

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) as Assessed by mRECIST	Objective response rate is defined as the proportion of participants who achieve a best overall response of complete response (CR) or partial response (PR) after treatment with NRT6003 Injection. Tumor response will be assessed according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) at protocol-defined imaging assessment time points.	Up to 12 months after NRT6003 administration
Incidence, Type, and Severity of Adverse Events and Serious Adverse Events	Safety will be assessed by the incidence, type, severity, seriousness, and relationship to study treatment of adverse events (AEs) and serious adverse events (SAEs). Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0).	From hepatic vascular evaluation through 12 months after NRT6003 administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) as Assessed by RECIST v1.1	Objective response rate is defined as the proportion of participants who achieve a best overall response of complete response (CR) or partial response (PR) after treatment with NRT6003 Injection. Tumor response will be assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) at protocol-defined imaging assessment time points.	Up to 12 months after NRT6003 administration
Disease Control Rate (DCR) as Assessed by mRECIST and RECIST v1.1	Disease control rate is defined as the proportion of participants who achieve complete response (CR), partial response (PR), or stable disease (SD) after treatment with NRT6003 Injection. DCR will be assessed and summarized separately according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) and Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) at protocol-defined imaging assessment time points.	Up to 12 months after NRT6003 administration
Duration of Response (DoR) as Assessed by mRECIST and RECIST v1.1	Duration of response is defined as the time from the first documented complete response (CR) or partial response (PR) to the first documented disease progression or death from any cause, whichever occurs first. DoR will be assessed and summarized separately according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) and Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).	From first documented response up to 12 months after NRT6003 administration
Progression-Free Survival (PFS) as Assessed by mRECIST and RECIST v1.1	Progression-free survival is defined as the time from NRT6003 administration to the first documented disease progression or death from any cause, whichever occurs first. Disease progression will be assessed and summarized separately according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) and Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).	Up to 12 months after NRT6003 administration
Progression-Free Survival in the Treated Area as Assessed by mRECIST and RECIST v1.1	Progression-free survival in the treated area is defined as the time from NRT6003 administration to the first documented disease progression within the treated area or death from any cause, whichever occurs first. Progression in the treated area will be assessed and summarized separately according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) and Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).	Up to 12 months after NRT6003 administration
Surgical Resection Rate After SIRT	Surgical resection rate is defined as the proportion of participants who undergo surgical resection during the follow-up period after NRT6003 Injection radioembolization. R0/R1 resection status and pathological findings may be summarized when surgical specimens are available.	Up to 12 months after NRT6003 administration

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): June 22, 2026
• Primary Completion (Estimated): December 21, 2027
• Study Completion (Estimated): December 21, 2027

Study Registration Dates

• First Submitted: June 15, 2026
• First Submitted That Met QC Criteria: June 15, 2026
• First Posted (Actual): June 18, 2026

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Amino Acids, Peptides, and Proteins; Proteins; Hydrolases; Enzymes; Enzymes and Coenzymes; Amidohydrolases; Transferases; Intracellular Signaling Peptides and Proteins; Glycosyltransferases; ADP Ribose Transferases; Pentosyltransferases; Group III Histone Deacetylases; Histone Deacetylases; Sirtuins
• Other Study ID Numbers: NRT6003-HCC-IIT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No