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Carcinoma, Hepatocellular clinical trials

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NCT ID: NCT00949182 Completed - Liver Cancer Clinical Trials

Sorafenib Tosylate Before and After Hepatic Arterial Chemoembolization With Doxorubicin Hydrochloride and Mitomycin C in Treating Patients With Localized Liver Cancer That Cannot Be Removed by Surgery

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

RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as doxorubicin hydrochloride and mitomycin C, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemoembolization kills tumor cells by carrying drugs directly into the tumor and blocking blood flow to the tumor. Giving sorafenib tosylate before and after chemoembolization may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects and how well giving sorafenib tosylate before and after hepatic arterial chemoembolization with doxorubicin hydrochloride and mitomycin C works in treating patients with localized liver cancer that cannot be removed by surgery.

NCT ID: NCT00946153 Completed - Clinical trials for Hepatocellular Carcinoma

Study of Lenvatinib (E7080) in Participants With Advanced Hepatocellular Carcinoma (HCC)

Start date: July 24, 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine maximum tolerated dose (MTD), efficacy, safety and tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor effect of E7080 when is administered continually once daily in participants with advanced hepatocellular carcinoma.

NCT ID: NCT00945568 Completed - Clinical trials for Hepatocellular Carcinoma

Preoperative Oral Supplementation With Branched-Chain Amino Acids (BCAA) Improves Postoperative Quality of Life

KMS
Start date: May 2007
Phase: N/A
Study type: Interventional

The aims of this study are (1) to study the benefit of branched-chain amino acids enriched nutrient-mixture by analyzing a variety of clinical parameter, including laboratory data, the duration of hospitalization after the surgery, and (2) To investigate the postoperative quality of life (QOL) in receiving peri-operatively branched-chain amino acids enriched nutrient-mixture in patients who undergone the hepatic management for hepatocellular carcinoma (HCC) with chronic liver disease.

NCT ID: NCT00943449 Completed - Clinical trials for Hepatocellular Carcinoma

4SC-201 (Resminostat) and Sorafenib in Advanced Hepatocellular Carcinoma

Shelter
Start date: July 2009
Phase: Phase 2
Study type: Interventional

The purpose of the study is to determine whether 4SC-201 alone or in combination with Sorafenib is effective and safe in the treatment of hepatocellular carcinoma in patients refractory to Sorafenib monotherapy.

NCT ID: NCT00941967 Completed - Liver Cancer Clinical Trials

Sorafenib With or Without Gemcitabine and Oxaliplatin in Treating Patients With Locally Advanced, Unresectable, or Metastatic Liver Cancer

Start date: December 2008
Phase: Phase 2
Study type: Interventional

RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine hydrochloride and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether sorafenib tosylate is more effective when given with or without gemcitabine hydrochloride and oxaliplatin in treating patients with liver cancer. PURPOSE: This randomized phase II trial is studying sorafenib tosylate to see how well it works when given with or without gemcitabine hydrochloride and oxaliplatin in treating patients with locally advanced, unresectable, or metastatic liver cancer.

NCT ID: NCT00936689 Completed - Clinical trials for Carcinoma, Hepatocellular

Traditional (Traditional Chemoembolization) TACE Versus Microsphere TACE

PRECISION-IT
Start date: March 2008
Phase: Phase 4
Study type: Interventional

Background Hepatic intra-arterial chemoembolization (TACE) is proposed when potentially curative therapy (eg. surgical resection, percutaneous ablation)is no longer possible. Prospective and non-randomized retrospective studies showed TACE to be capable to increase survival vs controls. In 2002 the first results of two RCTs were published which had been conducted on unresectable HCC patients, designed to assess the impact produced by TACE on survival, demonstrated a statistically significant advantage in TACE treated patients compared to controls. The same results have been confirmed by a meta-analysis conducted on 14 trials published in literature. The limitations of TACE are represented however by the difficulties in obtaining a complete necrosis of the lesion treated and for this reason new embolization agents are being developed to increase the efficacy of TACE in HCC as the microsphere, in poly vinyl alcohol and co-acrylic acid that are not reabsorbable and induce permanent embolization. The first experimental studies using microsphere showed the good tolerability and the higher rate of tumor necrosis, but no RCTs have been conducted to investigate their impact on survival. Objectives. The primary aim of this study is to compare 2 years survival of patients randomized to selective traditional TACE or selective TACE via microspheres loaded with Doxorubicin. Secondary objectives investigate the time to progression of disease (radiologic and symptomatic) by radiologic, laboratory tests and the QoL questionnaire administration. Methods. This is a multicentre, randomized, open-label, active controlled study in HCC patients treated with standard TACE vs TACE with doxorubicin - loaded microsphere. The study comprises a selection period, a treatment period and a follow up phase with a total duration of 2 years from randomization. Expected results. The sample size(alfa 5%, power 80%) is adequate to detect a 20% difference between TACE with microsphere vs traditional TACE.

NCT ID: NCT00933816 Completed - Clinical trials for Hepatocellular Carcinoma

Study of Sorafenib In Combination With Low-dose 5-fluorouracil/Cisplatin (FP) Intraarterial Infusion Chemotherapy

SILIUS
Start date: July 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine the recommended dose of the combination therapy of sorafenib with hepatic arterial infusion of low dose cisplatin and fluorouracil on patients with advanced hepatocellular carcinoma (Phase I), and to evaluate the efficacy of this combination therapy in the recommended dose (Phase II).

NCT ID: NCT00926536 Completed - Clinical trials for Carcinoma, Hepatocellular

Impact of C-arm CT in Patients With HCC Undergoing TACE: Optimal Imaging Guidance

Start date: April 2009
Phase: N/A
Study type: Interventional

Patients will be enrolled based on presence of HCC and eligibility for TACE. They will be randomized to one of two arms for imaging navigation to the optimal catheter location for chemotherapy injection to treat the first (possibly sole) tumor target. The two arms will be: TACE using F and DSA only, or TACE using F, DSA, and CACT. Navigation to subsequent treatment targets in all patients will be done with fluoroscopy, CACT, and DSA, as is standard of care at Stanford University Medical Center, and is not part of the study. Vascular complexity, which affects navigation difficulty and thus the need for imaging, will be assessed separately for use in data analysis by two radiologists on a four-point scale.

NCT ID: NCT00923897 Completed - Clinical trials for Hepatocellular Carcinoma

Palliative Radiotherapy (RT) for Liver Metastases (Mets) and Hepatocellular Carcinoma (HCC)(COLD 4)

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

Palliative radiotherapy is radiation treatment given to help reduce pain or discomfort, or other symptoms related to cancer. This is used commonly for cancer that has spread to the bones and brain, and for many other primary cancers that are too advanced to be cured, including lung cancer, pancreatic cancer and head and neck cancer. The benefits of palliative radiotherapy for advanced liver cancer have not been well studied. This study is designed to help to see whether palliative radiation therapy is effective in controlling pain, discomfort or other symptoms related to liver cancer, and how this therapy Phase II Trial of Palliative Radiotherapy for Locally Advanced Hepatocellular Carcinoma and Hepatic Metastases might affect the quality of life of patients receiving such therapy. This information will help the doctors understand if there are specific conditions under which radiation therapy is more effective and worthwhile, and how it may affect the quality of life for patients who have locally advanced hepatocellular carcinoma and hepatic metastasis.

NCT ID: NCT00920192 Completed - Clinical trials for Carcinoma, Hepatocellular

Safety Study of Foretinib (GSK1363089) in Adults With Liver Cancer

Start date: August 12, 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of foretinib (also known as GSK1363089) when used in the treatment of patients with advanced hepatocellular carcinoma (liver cancer).