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.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- Fase 2
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Jingjun Huang, MD
- Número de teléfono: +86-20-34156205
- Correo electrónico: junooi@foxmail.com
Ubicaciones de estudio
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510260
- The Second Affiliated Hospital, Guangzhou Medical University
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Contacto:
- Jingjun Huang, MD
- Número de teléfono: +86-20-34156205
- Correo electrónico: junooi@foxmail.com
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Investigador principal:
- Kangshun Zhu, MD
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Sub-Investigador:
- Jingjun Huang, MD
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
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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.
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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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Objective Response Rate (ORR) as Assessed by mRECIST
Periodo de tiempo: Up to 12 months after NRT6003 administration
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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.
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Up to 12 months after NRT6003 administration
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Incidence, Type, and Severity of Adverse Events and Serious Adverse Events
Periodo de tiempo: From hepatic vascular evaluation through 12 months after NRT6003 administration
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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).
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From hepatic vascular evaluation through 12 months after NRT6003 administration
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Objective Response Rate (ORR) as Assessed by RECIST v1.1
Periodo de tiempo: Up to 12 months after NRT6003 administration
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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.
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Up to 12 months after NRT6003 administration
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Disease Control Rate (DCR) as Assessed by mRECIST and RECIST v1.1
Periodo de tiempo: Up to 12 months after NRT6003 administration
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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.
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Up to 12 months after NRT6003 administration
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Duration of Response (DoR) as Assessed by mRECIST and RECIST v1.1
Periodo de tiempo: From first documented response up to 12 months after NRT6003 administration
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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).
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From first documented response up to 12 months after NRT6003 administration
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Progression-Free Survival (PFS) as Assessed by mRECIST and RECIST v1.1
Periodo de tiempo: Up to 12 months after NRT6003 administration
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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).
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Up to 12 months after NRT6003 administration
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Progression-Free Survival in the Treated Area as Assessed by mRECIST and RECIST v1.1
Periodo de tiempo: Up to 12 months after NRT6003 administration
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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).
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Up to 12 months after NRT6003 administration
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Surgical Resection Rate After SIRT
Periodo de tiempo: Up to 12 months after NRT6003 administration
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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.
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Up to 12 months after NRT6003 administration
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Neoplasias por tipo histológico
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Enfermedades del HIGADO
- Neoplasias Glandulares y Epiteliales
- Adenocarcinoma
- Neoplasias Hepaticas
- Carcinoma
- Carcinoma Hepatocelular
- Aminoácidos, péptidos y proteínas
- Proteínas
- Hidrolasas
- Enzimas
- Enzimas y coenzimas
- Amidohidrolasas
- Transferasas
- Péptidos de señalización intracelular y proteínas
- Glicosiltransferasas
- ADP Ribose Transferasas
- Pentosiltransferasas
- Histona Desacetilasas del Grupo III
- Histona Desacetilasas
- Sirtuinas
Otros números de identificación del estudio
Otros números de identificación del estudio
- NRT6003-HCC-IIT
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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