Yttrium-90 Carbon Microsphere Radioembolization in Previously Treated Hepatocellular Carcinoma

NCT07657273 | Not Yet Recruiting Phase 2

• 1 other identifier: NRT6003-HCC-IIT
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Objective Response Rate (ORR) as Assessed by RECIST v1.1

  Up to 12 months after NRT6003 administration

• Disease Control Rate (DCR) as Assessed by mRECIST and RECIST v1.1

  Up to 12 months after NRT6003 administration

• Duration of Response (DoR) as Assessed by mRECIST and 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

  Up to 12 months after NRT6003 administration

• Progression-Free Survival in the Treated Area as Assessed by mRECIST and RECIST v1.1

  Up to 12 months after NRT6003 administration

Study Arms (1)

NRT6003 Injection Radioembolization

EXPERIMENTAL

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

Interventions

NRT6003 Injection DRUG

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.

Also known as: Yttrium-90 Carbon Microspheres, Y-90 Carbon Microspheres, Selective Internal Radiation Therapy, SIRT, Transarterial Radioembolization, TARE

NRT6003 Injection Radioembolization

Eligibility Criteria

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

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

The Second Affiliated Hospital, Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sirtuins

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Group III Histone Deacetylases; Histone Deacetylases; Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; ADP Ribose Transferases; Pentosyltransferases; Glycosyltransferases; Transferases; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Jingjun Huang, MD

CONTACT

+86-20-34156205; junooi@foxmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 18, 2026
• Study Start: June 22, 2026
• Primary Completion (Estimated): December 21, 2027
• Study Completion (Estimated): December 21, 2027
• Last Updated: June 18, 2026

Record last verified: 2026-06

Locations

CN (1)