Hepatocellular Carcinoma: Reasons for Phase III Failure and Novel Perspectives on Trial Design Running title: Reasons for phase III failure in HCC
نویسندگان
چکیده
1 HCC Translational Research Laboratory, Barcelona-Clínic Liver Cancer Group, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Hospital Clínic de Barcelona, Universitat de Barcelona (UB), Barcelona, Catalonia, Spain. 2 Mount Sinai Liver Cancer Program, Division of Liver Diseases, Tisch Cancer Institute, Ichan School of Medicine at Mount Sinai, New York, New York, USA. 3 Institució Catalana de Recerca i Estudis Avançats, Barcelona, Catalonia, Spain
منابع مشابه
Hepatocellular carcinoma: reasons for phase III failure and novel perspectives on trial design.
Hepatocellular carcinoma (HCC) is a major health problem. Most patients with HCC experience a recurrence after resection/ablation or are diagnosed at advanced stages. Sorafenib remains the only approved systemic drug for these patients. Molecular therapies targeting signaling cascades involved in hepatocarcinogenesis have been explored in phase III clinical trials. However, none of the drugs te...
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Background: Since the approval of sorafenib there have been numerous failures of new agents in Phase III studies for treatment of advanced hepatocellular carcinoma (HCC). These studies have generally ignored the molecular heterogeneity of HCC and they have not enrolled patients based on predictive markers of response. The development of molecular targeted therapeutics in HCC needs to model the ...
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TO THE EDITOR: Nowadays, the position of sorafenib in the treatment of advanced hepatocellular carcinoma (HCC) is frequently challenged by other molecular targeted agents. However, regardless of whether they are considered as first-line or second-line treatment options, all completed phase III randomized controlled trials (RCTs) report negative results. Similarly, two phase III RCTs (Comparison...
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BACKGROUND Since the approval of sorafenib there have been numerous failures of new agents in Phase III studies for treatment of advanced hepatocellular carcinoma (HCC). These studies have generally ignored the molecular heterogeneity of HCC and they have not enrolled patients based on predictive markers of response. The development of molecular targeted therapeutics in HCC needs to model the a...
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OBJECTIVES To evaluate the efficacy and safety of erlotinib for the treatment of advanced hepatocellular carcinoma (HCC). METHODS A systematic literature search was undertaken in June 2015. Phase II/III trials of erlotinib for the treatment of advanced HCC were included. A descriptive analysis was applied. The study was conducted in College of Medicine, Honghui Hospital, Xi'an Jiaotong Univer...
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