- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01328223
Study of Combined Sorafenib With Radiotherapy in Patients With Advanced Hepatocellular Carcinoma
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Antecipado)
Contactos e Locais
Locais de estudo
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-
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Taichung, Taiwan, 404
- Recrutamento
- Shang-Wen Chen
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Contato:
- Shang-Wen Chen, MD
- Número de telefone: 7450 886-4-22052121
- E-mail: vincent1680616@yahoo.com.tw
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Subinvestigador:
- Yu-Cheng Kuo
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Subinvestigador:
- Ji-An Liang, MD
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Tainan, Taiwan, 700
- Recrutamento
- Li-Ching Lin
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Contato:
- Li-Ching Lin, MD
- E-mail: liching51@yahoo.com.tw
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Taipei, Taiwan, 100
- Recrutamento
- Jeng-Fong Chiou
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Contato:
- Jeng-Fong Chiou, MD;PhD
- E-mail: sjfchiou@xuite.net
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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:
- Child-Pugh C
- CLIP score ≧ 4
- Patients with evidence of extrahepatic or metastatic disease
- Patients with evidence of massive ascites
- Patients receiving previous irradiation to liver
- Patients with previous use of Thalidomide less than 6 months from entering of the study
- 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)
- Active clinically serious infections ( > grade 2 CTC version 2)
- Patients undergoing renal dialysis
- Patients with evidence or history of bleeding diathesis
- Prior treatment with EGFR TKIs or VEGFR TKIs
- Hypertension uncontrolled by medical therapy
- 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.
- Chemotherapy or immunotherapy or other systemic anti-cancer therapy within 4 weeks.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
---|---|
radiotherapy efficacy
|
Concurrent and maintenance sorafenib 400mg twice daily
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Response rate
Prazo: 6 months
|
|
6 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Disease progression-free survival
Prazo: 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
Prazo: 2 years
|
Participants will be followed.
The average time period will be two years.
|
2 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Shang-Wen Chen, MD, Department of Radiation Oncology, China Medical University Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças do aparelho digestivo
- Neoplasias por Tipo Histológico
- Neoplasias
- Neoplasias por local
- Adenocarcinoma
- Neoplasias Glandulares e Epiteliais
- Neoplasias do Aparelho Digestivo
- Doenças do Fígado
- Neoplasias Hepáticas
- Carcinoma
- Carcinoma Hepatocelular
- Mecanismos Moleculares de Ação Farmacológica
- Inibidores Enzimáticos
- Agentes Antineoplásicos
- Inibidores de proteína quinase
- Sorafenibe
Outros números de identificação do estudo
- Radiotherapy-Sorafenib
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