- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03113955
STOPPER CHINA:With Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma
A Single-arm Trial of Transcatheter Arterial Chemoembolization With Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Beijing
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Beijing, Beijing, Porcelana
- Beijing Cancer Hospital
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Beijing, Beijing, Porcelana
- Cancer Hospital Chinese Academy of Medical Sciences
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Guangdong
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Guangzhou, Guangdong, Porcelana
- Guangdong Nanfang Hospital
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Henan
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Zhengzhou, Henan, Porcelana
- Henan cancer hospital
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Jiangsu
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Nanjing, Jiangsu, Porcelana
- Zhongda Hospital Affiliated Southeast University
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Liaoning
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Shenyang, Liaoning, Porcelana
- Shengjing Hospital Affiliated China Medical University
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Shanghai
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Shanghai, Shanghai, Porcelana
- Shanghai Zhongshan Hospital
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Zhejiang
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Hangzhou, Zhejiang, Porcelana
- Zhejiang Cancer Hospital
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Hangzhou, Zhejiang, Porcelana
- The First Affiliated Hospital, Zhejiang University
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Hangzhou, Zhejiang, Porcelana
- Second Aff. Hosp. of Zhejiang University College of Medicine
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Subject is able to provide informed consent and must sign the Institutional Review Board/Ethics Committee (IRB/EC) approved Informed Consent Form.
- Male or female of age ≥18 and ≤75 years.
- Confirmed diagnosis of HCC according to the diagnostic criteria included in the management guideline issued by China's Ministry of Health in 2017.
- HCC is diagnosed for the first time or recurrence of tumor after surgical or ablation treatment.
- Single tumor less than 7cm in diameter or multiple tumors with maximum 3 lesions with >1cm in diameter, individual diameter <7cm and less than 10cm in total diameter.
- no previous chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy) for HCC
- Preserved liver function (Child-Pugh A or B7).
- ECOG Performance Status 0 or 1.
Exclusion Criteria:
- Presence of vascular invasion or extra-hepatic spread of disease, or diffuse HCC, defined as >50% liver involvement , or arteriovenuous fistula
- Macrovascular invasion of main or primary branches of portal vein at entry into the study
- Any contraindication for TACE treatment
- Any contraindication for Epirubicin administration
- Advanced liver disease (bilirubin levels >2 mg/dl, AST or ALT >5 times upper limit of normal)
- Renal failure or insufficient renal function (Creatinine levels >2 mg/dl)
- Subject unable to receive MRI examination
- Pregnant or breast feeding woman, or plan to become pregnant during treatment or within 12 months of treatment
- couldn't commit reliable birth control measures during treatment or within 12 months of treatment
- Subject is participating other investigational drug or device clinical trial within 30 days of signing the informed consent
- Subject is not suitable to participate in the study as judged by investigator
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)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: single -arm
A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma
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The primary objective of this study is to evaluate the safety and efficacy of transcatheter arterial chemoembolization with Tandem Microspheres loaded with Epirubicin in the treatment of patients with localized hepatocellular carcinoma (HCC)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Participants With Objective Tumor Response at 6 Months by MRI (Magnetic Resonance Imaging)
Periodo de tiempo: At 6 months
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The objective response rate measured by MRI used EASL (European Society for the Study of the Liver) and mRECIST (Improved criteria for evaluating the efficacy of solid tumors) , Overall Response (OR) = CR + PR.
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At 6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Kaplan-Meier Analyses the Percent of Participants for Time to Progression (TTP) at 12 Months
Periodo de tiempo: At 12 months
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Kaplan-Meier analyses the percent of participants for TTP which is defined as the length of time from the treatment initiation to either the date of the first disease progression occurred, as assessed by the investigators, or the date of the subject died due to any cause, whichever comes earlier. EASL and mRECIST response assessment of target lesion for HCC. TTP (also referred as "time to treatment failure") will be measured by a few data items list below:
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At 12 months
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Number of Participants With Objective Tumor Response at 30-day
Periodo de tiempo: At 1month
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The objective response rate measured by MRI used EASL (European Society for the Study of the Liver) and mRECIST (Improved criteria for evaluating the efficacy of solid tumors) , Overall Response (OR) = CR + PR.
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At 1month
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Kaplan-Meier Analyses the Percent of Participants for PPF(Proportion Progression-Free) at 12 Months
Periodo de tiempo: from first TACE to 12 months
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Kaplan-Meier analyses the percent of participants for PPF which is defined as the length of time from the treatment initiation, that treated subjects are still progression-free. EASL and mRECIST response assessment of target lesion for HCC. The data items to be captured will include:
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from first TACE to 12 months
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Kaplan-Meier Analyses the Percent of Participants for Overall Survival
Periodo de tiempo: from first TACE to 12 months
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Kaplan-Meier analyses the percent of participants for Overall survival which is defined as the length of time from the treatment initiation, that treated subjects are still alive. The Kaplan-Meier analysis is aimed to capture the all-cause death for each subject. Subjects who are lost-to-follow will be considered being censored. There are three critical data items to be captured:
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from first TACE to 12 months
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Number of Adverse Events Relate to Study Device in 12 Months Post Procedure
Periodo de tiempo: in 12 months
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Number and documents of adverse events relate to study device in 12 months post procedure
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in 12 months
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Number of Participants With Objective Tumor Response at 3 Months
Periodo de tiempo: At 3 months
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The objective response rate measured by MRI used EASL (European Society for the Study of the Liver) and mRECIST (Improved criteria for evaluating the efficacy of solid tumors) , Overall Response (OR) = CR + PR.
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At 3 months
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Kaplan-Meier Analyses the Percent of Participants for Time to Extrahepatic Spread
Periodo de tiempo: At 12 month
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Kaplan-Meier analyses the percent of participants for Time to Extrahepatic Spread which the length of time from the treatment initiation to the development of extrahepatic spread of the disease via imaging assessment. The data items to be considered will include:
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At 12 month
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Cathy Peng, BSC China
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Neoplasias por tipo histológico
- Neoplasias
- Neoplasias por sitio
- Adenocarcinoma
- Neoplasias Glandulares y Epiteliales
- Neoplasias del Sistema Digestivo
- Enfermedades del HIGADO
- Neoplasias Hepaticas
- Carcinoma
- Carcinoma Hepatocelular
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antineoplásicos
- Inhibidores de la topoisomerasa II
- Inhibidores de la topoisomerasa
- Antibióticos, Antineoplásicos
- Epirubicina
Otros números de identificación del estudio
- S2382
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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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