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Carcinoma, Hepatocellular clinical trials

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NCT ID: NCT00919009 Completed - Clinical trials for Carcinoma, Hepatocellular

Combination of Transcatheter Arterial Chemoembolization (TACE) and Sorafenib for Patients With Unresectable Hepatocellular Carcinoma (HCC)

Start date: June 2009
Phase: Phase 2
Study type: Interventional

Most HCC patients are diagnosed at advanced stages in Korea, transcatheter arterial chemoembolization is considered a key modality for palliative treatment in these HCC patients. TACE is currently one of the mainstays of palliative treatments worldwide for patients with inoperable HCC and it has shown survival benefits in patients with unresectable HCC. TACE consists primarily of directly targeted chemotherapy and embolization of arteries feeding the tumors, inevitably resulting in a hypoxic insult to HCC and surrounding liver tissues. Ischemic injury after TACE has been found to induce the upregulation of circulating vascular endothelial growth factor (VEGF), which is essential for tumor growth, invasion and metastasis in patients with HCC. Recent studies have shown a significant correlation between pre-TACE level of circulating VEGF or VEGF upregulation after TACE and HCC characteristics, including tumor size, vascular invasion, and metastasis. TACE consists primarily of directly targeted chemotherapy and embolization of arteries feeding the tumors, inevitably resulting in a hypoxic insult to HCC and surrounding liver tissues. Central tumor hypoxia was found to upregulate proangiogenic growth factors, which are potent mediators of tumor angiogenesis. Therefore, expression of circulating or tissue VEGF was enhanced after TACE in patients or animals with HCC, and there could be some probability of adverse effects of TACE in HCC patients. In addition, the investigators demonstrated that a transient increment of serum VEGF level after TACE was significantly correlated with poor outcomes of tumor progression, especially outcomes relevant to distant metastasis. Therefore, these findings suggest a rationale for applying adjuvant therapy with anti-angiogenesis agent additional treatment of anti-angiogenesis after TACE or during TACE in a selected group of patients HCC. The aim of this study is to evaluate efficacy and safety of sorafenib 400 mg bid with TACE in patients with unresectable and/or inoperable HCC.

NCT ID: NCT00914355 Completed - Clinical trials for Hepatocellular Carcinoma

Stereotactic Body Radiation Therapy (SBRT) Hepatocellular Carcinoma (COLD 2)

Start date: August 2007
Phase: Phase 2
Study type: Interventional

This study is designed to see whether stereotactic body radiation therapy (SBRT) can reduce tumour size, slow progression of the disease, prolong life and improve quality of life of patients with hepatocellular carcinoma, a cancer of the liver, that cannot be removed surgically (unresectable) and cannot be treated with ablative therapy (e.g. radio-frequency ablation) or trans-arterial chemo-embolization (TACE) therapy (delivery of chemotherapy through an artery that feeds into the liver). SBRT is concentrated focused radiation therapy delivered very precisely to the liver tumour. It is hoped that knowledge obtained from this study will improve our ability to treat patients with liver tumours that cannot be treated with surgery and other methods, and that SBRT may prove to be a treatment that can lead to long-term and permanent control of liver tumours for some patients.

NCT ID: NCT00913757 Completed - Clinical trials for Carcinoma, Hepatocellular

A Study of Molecular and Genetic Factors for Liver Cancer in the Greater Baltimore Area

Start date: July 1, 2009
Phase:
Study type: Observational

Background: - Liver cancer is the third most deadly and fifth most common cancer worldwide. Hepatocellular carcinoma (HCC) is the most frequent primary liver cancer, and it has grown more prevalent in the United States. - More information is needed about the causes and effects of liver cancer, and further research into individuals who are at high risk for developing liver cancer is needed for early diagnosis and prevention. Objectives: - To identify genetic factors that may help to explain the aggressiveness of liver cancer. - To determine if HCC biomarkers exist in blood, urine, and tissue samples. Eligibility: - Patients between the ages of 18 and 90 who have been diagnosed with HCC or have a high risk for developing HCC because of fatty liver disease (alcohol-related or non-alcohol-related) or chronic hepatitis B or C. - Participants will reside in Baltimore City and the surrounding areas. Design: - Participants will complete a questionnaire and provide blood and urine samples for testing: - The questionnaire will include questions about individual and family medical history, tobacco use, and exposure to known factors for liver cancer. - Blood and urine samples will be collected from all participants after the questionnaire. - Tumor tissue and healthy tissue will be collected from selected participants if they undergo surgery for their cancer or disease. - No specific treatment will be offered as part of this protocol, but participants have the option to be treated under different protocols.

NCT ID: NCT00912847 Completed - Hepatitis B Virus Clinical Trials

Validity and Cost-Effectiveness of a New Screening Test for Hepatocellular Carcinoma

Start date: October 1997
Phase: N/A
Study type: Observational

The purpose of this study is: 1. To establish and compare the diagnostic utilities for hepatocellular carcinoma (HCC) screening tests of (a) HS-AFP, (b) AFP + US,(c) AFP alone and (d) US alone (within HBV carriers between age 40 and 70 years); 2. To establish the cost-effectiveness of the screening tests; 3. To compare tumor sizes, resection rates, and survival rates up to 18 months between those who were screened by HS-AFP those of a historical control group that was not screened.

NCT ID: NCT00911196 Completed - Clinical trials for Hepatocellular Carcinoma

Analysis of Expression of Specific Markers and Their Prognostic Significance in Hepatocellular Carcinoma

Start date: November 2008
Phase: N/A
Study type: Observational

Hepatocellular carcinoma is an aggressive disease with limited therapeutic options. Therefore, new approaches to treat this type of cancer are needed with immunotherapy potentially being one of these. As a first step in the development of novel therapies, expression analysis of specific markers, including tumor antigens will be carried out, and the correlation of expression with disease variables and clinical outcome will be assessed. This will be done retrospectively using archived hepatocellular carcinoma tissue samples.

NCT ID: NCT00910572 Completed - Clinical trials for Hepatocellular Carcinoma

Radioembolization With Yttrium-90 Microspheres for Intermediate or Advanced Hepatocellular Carcinoma

Start date: July 2007
Phase: Phase 2
Study type: Interventional

Rationale: Patients diagnosed with hepatocellular carcinoma (HCC) at an intermediate or advanced stage (according to the BCLC classification system) are not amenable of curative treatment. According to EASL and AASLD guidelines patients with an intermediate stage HCC are treated with trans-arterial chemoembolization (TACE) while patients with an advanced stage HCC are treated with molecular targeted drugs or other combinations according to their liver function. The median survival expected for patients in intermediate-advanced stages ranges from 11 to 20 months. Purpose of the Study: The purpose of this prospective phase II study is to determine whether or not Radioembolization with Yttrium-90 microspheres (TheraSphere®) provides an anti-tumoral effect and a sensible benefit in terms of time-to-progression (TTP) and survival in patients with good liver function (Child A-B7) and a confirmed diagnosis of Intermediate or Advanced (because of the presence of neoplastic portal thrombosis) Hepatocellular Carcinoma (HCC).

NCT ID: NCT00908752 Completed - Clinical trials for Hepatocellular Carcinoma

Phase III Trans-Arterial Chemo-Embolization (TACE) Adjuvant HCC

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Start date: July 20, 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the Overall Survival (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE therapy.

NCT ID: NCT00906373 Completed - Clinical trials for Hepatocellular Carcinoma

A Study of IMC-A12 in Combination With Sorafenib in Participants With Advanced Cancer of the Liver

Start date: May 2009
Phase: Phase 2
Study type: Interventional

To determine if IMC-A12 given in combination with Sorafenib is safe and effective for participants with advanced liver cancer.

NCT ID: NCT00901901 Completed - Clinical trials for Carcinoma, Hepatocellular

Nexavar-Tarceva Combination Therapy for First Line Treatment of Patients Diagnosed With Hepatocellular Carcinoma

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Start date: May 21, 2009
Phase: Phase 3
Study type: Interventional

This is a randomized trial to evaluate the clinical benefit of sorafenib 400 mg twice daily and erlotinib 150 mg once a day versus sorafenib 400 mg twice daily and placebo erlotinib once daily in subjects with unresectable advanced or metastatic Child-Pugh A HCC. Patients who are candidates for potentially curative intervention (i.e. surgical resection or local ablation) are not eligible for this study.

NCT ID: NCT00892658 Completed - Clinical trials for Hepatocellular Carcinoma

Sorafenib-RT in Treating Hepatocellular Carcinoma (SHEP)

Start date: January 2009
Phase: Phase 1
Study type: Interventional

Hepatocellular carcinoma (HCC) is one of the most common cancers worldwide. The incidence is highest in Asia and it is increasing in North America, with a two to three fold increase in mortality in North America expected over the next two decades. Previous research has shown that tumours often have abnormal blood vessels that may reduce the effect of radiation therapy. New drugs, known as "anti-angiogenic" drugs have been shown in animal and human studies to damage or change tumour blood vessels in ways that may make tumors more sensitive to radiation treatment. 38-44 patients diagnosed with HCC will be invited to take part in this study. Upon completion, this study will establish the safety of the combination of radiation and sorafenib in patients with HCC. This will also establish preliminary data regarding efficacy of the combination and investigate potential imaging and serum/tissue markers surrogates for tumor response and/or drug activity.