- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03416803
A Study of Individualized Radiotherapy Based on a Prediction Model of Lymph Node Metastasis in Hepatocellular Carcinoma
Prediction of Lymph Node Metastasis in Hepatocellular Carcinoma and the Study of Individualized Radiotherapy
Objectives:
- To further validate the predictive efficacy of our established microRNA prediction model of HCC lymph node metastasis.
- To establish a precise therapeutic mode of prophylactic radiation therapy in high-risk patients with HCC with lymph node metastasis under the guidance of a microRNA prediction model.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
First, screening out patients who underwent hepatic tumor resection and pathologically diagnosed as HCC .
Then,performing the detection of miR-145, miR-31 and miR-92a by using the HCC lymph node metastasis microRNA correlation prediction model established in our previous study. The patients are judged as high risk of lymph node metastasis and low risk Patients, then high-risk patients under the condition of informed consent into the group, randomized into treatment group and control groups.
Last, Patients enrolled in the treatment group were treated with radiotherapy and followed up.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Shanghai, Porcelana, 200032
- Reclutamiento
- 180 Fenglin Road
-
Contacto:
- Zhaochong Zeng, Phd
- Número de teléfono: 86-13817076800
- Correo electrónico: zeng.zhaochong@zs-hospital.sh.cn
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- patients underwent liver tumor resection and pathological diagnosis of HCC in our hospital.
- The tumor samples of these HCC patients were detected by in situ hybridization with miR-145, miR-31 and miR-92a. We used the previously established HCC lymph node metastasis microRNA prediction model to determine the patients with high-risk lymph node metastasis and low-risk patients at high risk Patients were randomly assigned into treatment group and control group with informed consent.
- HCC patients were not receive other anti-cancer treatment.
- Blood routine examination was normal.
- Child-Pugh grade A, normal liver and kidney function in the normal range (including ALT or ASL within 2.5 times the normal), WBC> 3 × 109 / L, Hb> 90g / L, PLT> 50 × 109 /
- HCC patients were not receive the history of upper abdominal radiotherapy.
- sign the informed consent.
- age 18-75 years old.
- KPS score 80-100 points.
Exclusion Criteria:
- accepted other anti-cancer treatment.
- Patients was determined to be low-risk lymph node metastasis by the pre-established HCC lymph node metastasis microRNA prediction model.
- blood and liver and kidney dysfunction.
- can not control the infection.
- at the same time the merger of other malignant tumors.
- while using other experimental drugs or to participate in other clinical trials.
- serious heart, lung, kidney disease.
- pregnant or lactating women.
- serious nervous system disease, can not clearly tell the treatment
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Radiotherapy
Patients in the experimental group, who were at high risk for lymph node metastasis, underwent radiotherapy in the lymphatic drainage area.
Radiotherapy was started in lymphatic drainage areas about 1 month after HCC surgery.
The range of radiotherapy was hepatic portal area, pancreas circumference, celiac trunk and abdomen Around the aortic lymph drainage area, the dose of radiation 45Gy, conventional segmentation.
|
Radioterapia
|
Sin intervención: Blank control
Patients in the control group , who were at high risk for lymph node metastasis,were followed up.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
2-year overall survival
Periodo de tiempo: The outcome measures are assessed up to 2 years.
|
The therapeutic effects are mainly evaluated by the 2-year overall survival.
|
The outcome measures are assessed up to 2 years.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Zhongshan Hospital, PhD, Fudan University, Shanghai,China
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
- Procesos Patológicos
- Neoplasias por tipo histológico
- Neoplasias
- Neoplasias por sitio
- Adenocarcinoma
- Neoplasias Glandulares y Epiteliales
- Neoplasias del Sistema Digestivo
- Enfermedades del HIGADO
- Neoplasias Hepaticas
- Procesos Neoplásicos
- Carcinoma
- Carcinoma Hepatocelular
- Metástasis de neoplasias
- Metástasis linfática
Otros números de identificación del estudio
- ZS-LNM-2017
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .