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Study of Combined Sorafenib With Radiotherapy in Patients With Advanced Hepatocellular Carcinoma

1 de abril de 2011 actualizado por: China Medical University Hospital

Phase II Study of Combined Sorafenib With Radiotherapy in Patients With Advanced Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) is a common cause of cancer mortality in Asia. Most patients present with intermediate or advanced disease. Percutaneous ethanol injection, radiofrequency ablation, and transcatheter arterial chemoembolization (TACE) are not considered as a curative treatment and have achieved very limited success in eradicating large HCC. With the development of new radiotherapy (RT) technique, RT can be more safely given to patients with larger tumor burden. Thus, TACE combined with RT has been suggested for treating large HCC. Based on the results of these studies, RT could achieve a tumor response rate of 50 % to 70 %. However, it has not been definitively shown to prolong the overall or disease-free survival due to lack of a phase III clinical trial. In contrast, a retrospective clinical investigation with molecular study suggests that sublethal dose of RT promoted HCC growth outside RT field.

Two phase III trials were shown to be efficacious and well-tolerated in patients with advanced HCC. Median overall survival was significantly 2 to 3 months longer in the sorafenib group than that in the placebo. It is interesting to recognize the combined therapeutic effect of RT with sorafenib. Based on several preclinical experiments, tumor angiogenesis inhibitors seem to be synergistic with irradiation when using before RT, concurrently with RT, or after RT. Thus, the investigators design a single-arm phase II clinical trial to investigate the efficacy of combined RT with sorafenib.

The eligibility criteria are patients with unresectable HCC; good performance status; no prior radiotherapy for the liver; clinical measurable tumor; good liver function and good compliance. After entering this study, the testee will receive RT to hepatic tumor with concurrently sorafenib with a dose of 400 mg twice daily. Hepatic RT will be performed with a daily fraction size of 2.0 to 2.5 Gy to a total dose of 46 Gy to 60 Gy. After RT, maintenance sorafenib with a dose of 400 mg twice daily will be ongoing. Sorafenib will be continued until the occurrence of clinical or radiologic progression, or the occurrence of either unacceptable adverse events or death. Minimum maintenance duration of 6 months is recommended, but not mandatory.

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Descripción detallada

The primary end points are response rate and toxicities profile. The secondary endpoints are time to disease-free survival, overall survival, and quality of life assessment.

Tipo de estudio

De observación

Inscripción (Anticipado)

45

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Taiwán
      • Taichung, Taiwán, 404
        • Reclutamiento
        • Shang-Wen Chen
        • Contacto:
        • Sub-Investigador:
          • Yu-Cheng Kuo
        • Sub-Investigador:
          • Ji-An Liang, MD
      • Tainan, Taiwán, 700
      • Taipei, Taiwán, 100
        • Reclutamiento
        • Jeng-Fong Chiou
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

20 años a 69 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Paitents with unresectable hepatoma with transarterial chemoembolization (TACE) failure or who are not suitable for TACE.

Descripción

Inclusion Criteria:

  • Patients with unresectable hepatoma with transarterial embolization (TAE) failure or who are not suitable for TACE. A maximal tumor diameter > 3.0 cm.
  • Age: 20 ~ 69 years.
  • ECOG 0 or 1.
  • Life expectancy of at least 12 weeks.
  • Child-Pugh A or B (preferentially score ≦ 7).
  • Cancer of the Liver Italian Program (CLIP) score ≦ 3.

  • Pretreatment liver function test and renal function test:

    • Total bilirubin < 1.5 times the upper limit of normal (ULN)(≦ 3.0 (ULN) in patients treated by biliary drainage for obstructive jaundice)
    • GOP/GPT ≦ 5 X of upper limit of normal range
    • Alkaline phosphatase ≦ 4X of upper limit of normal range
    • Prothrombin time/partial prothrombin time < 1.5 X of ULN
    • Serum Creatinine ≦ 1.0 x ULN

  • Pretreatment blood count:

    • Hemoglobulin ≧ 9 g/dl
    • Absolute neutrophil count ≧ 1500/mm3
    • Platelet count ≧ 50,000/mm3
  • Subjects with at least one uni-dimensional or bi-dimensional measurable lesion. Lesion must be measured by CT scan or MRI.
  • Patients must fully recover from prior therapy that given > 4 weeks before enrollment.
  • Signed informed consent must be obtained prior to any study related procedures.

Exclusion Criteria:

  1. Child-Pugh C
  2. CLIP score ≧ 4
  3. Patients with evidence of extrahepatic or metastatic disease
  4. Patients with evidence of massive ascites
  5. Patients receiving previous irradiation to liver
  6. Patients with previous use of Thalidomide less than 6 months from entering of the study
  7. History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrythmias requiring anti-arrythmic therapy (beta blockers or digoxin are permitted)
  8. Active clinically serious infections ( > grade 2 CTC version 2)
  9. Patients undergoing renal dialysis
  10. Patients with evidence or history of bleeding diathesis
  11. Prior treatment with EGFR TKIs or VEGFR TKIs
  12. Hypertension uncontrolled by medical therapy
  13. Symptomatic metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry. Also the patient must not be undergoing acute steroid therapy or taper.
  14. Chemotherapy or immunotherapy or other systemic anti-cancer therapy within 4 weeks.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
radiotherapy efficacy
  1. Concurrent stage with RT: sorafenib 400mg twice daily
  2. Maintenance stage after RT: sorafenib 400mg twice daily Treatment can be continued until the occurrence of clinical or radiologic progression, the occurrence of either unacceptable adverse events, death, or any criteria met for removal from the protocol treatment. Basically, minimum maintenance duration of 6 months is recommended, not mandatory.
Radiación: sorafenib and radiotherapy for hepatocellular carcinoma
Concurrent and maintenance sorafenib 400mg twice daily
Otros nombres:
  • Combined radiotherapy and sorafenib.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Response rate
Periodo de tiempo: 6 months
  1. The tumor response rate will be evaluated at the 6th month after the ending of radiotherapy.
  2. The response rate includes complete and partial response according to the RECIST (Response Evaluation Criteria in Solid Tumors) criteria.
6 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Disease progression-free survival
Periodo de tiempo: 2 years

Disease progression-free survival:

Patients with the evidence of clinical or radiographic progressive disease will be defined as disease progression. The average time period for the follow-up will be two years.
2 years
Overall survival
Periodo de tiempo: 2 years
Participants will be followed. The average time period will be two years.
2 years

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

China Medical University Hospital

Investigadores

  • Investigador principal: Shang-Wen Chen, MD, Department of Radiation Oncology, China Medical University Hospital

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de septiembre de 2010

Finalización primaria (Anticipado)

1 de junio de 2012

Finalización del estudio (Anticipado)

1 de diciembre de 2012

Fechas de registro del estudio

Enviado por primera vez

20 de marzo de 2011

Primero enviado que cumplió con los criterios de control de calidad

1 de abril de 2011

Publicado por primera vez (Estimar)

4 de abril de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

4 de abril de 2011

Última actualización enviada que cumplió con los criterios de control de calidad

1 de abril de 2011

Última verificación

1 de marzo de 2011

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • Radiotherapy-Sorafenib

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. .

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