Yttrium-90 Carbon Microsphere Radioembolization in Previously Treated Hepatocellular Carcinoma

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Objective Response Rate (ORR) as Assessed by mRECIST [Time frame: Up to 12 months after NRT6003 administration]
• Incidence, Type, and Severity of Adverse Events and Serious Adverse Events [Time frame: From hepatic vascular evaluation through 12 months after NRT6003 administration]

Secondary outcome measures (6)

• Objective Response Rate (ORR) as Assessed by RECIST v1.1 [Time frame: Up to 12 months after NRT6003 administration]
• Disease Control Rate (DCR) as Assessed by mRECIST and RECIST v1.1 [Time frame: Up to 12 months after NRT6003 administration]
• Duration of Response (DoR) as Assessed by mRECIST and RECIST v1.1 [Time frame: From first documented response up to 12 months after NRT6003 administration]
• Progression-Free Survival (PFS) as Assessed by mRECIST and RECIST v1.1 [Time frame: Up to 12 months after NRT6003 administration]
• Progression-Free Survival in the Treated Area as Assessed by mRECIST and RECIST v1.1 [Time frame: Up to 12 months after NRT6003 administration]
• Surgical Resection Rate After SIRT [Time frame: Up to 12 months after NRT6003 administration]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The Second Affiliated Hospital, Guangzhou Medical University — Guangzhou

Identifiers

NCT: NCT07657273 · NRT6003-HCC-IIT

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗