View clinical trials related to Carcinoma, Hepatocellular.
Filter by:The purpose of this phase I study is to determine the maximal tolerable dose (MTD) of thalidomide (THADO®) in combination with fixed dose of sorafenib (NEXAVAR®) for the treatment of advanced or metastatic HCC. The Phase II purpose of this study is to determine the disease control rate (complete response + partial response + stable disease) for at least 4 months of sorafenib (NEXAVAR®) plus phase I determined MTD of thalidomide (THADO®) in patients with advanced or metastatic HCC.
The objective of this pilot study is to evaluate the safety, tolerability and activity of the monoclonal antibody CT-011 administered intravenously to patients with Primary Hepatocellular Carcinoma.
RATIONALE: Panobinostat and sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of liver cancer by blocking blood flow to the tumor. PURPOSE: This phase I trial is studying the side effects and best dose of panobinostat when given together with sorafenib in treating patients with liver cancer that is metastatic and/or cannot be removed by surgery.
The current understanding of PR104 justifies the evaluation of PR104 with sorafenib in patients with hepatocellular carcinoma. These include: - Hypoxia. Hepatocellular Carcinoma (HCC) is likely to demonstrate a level of hypoxia sufficient to activate PR104 to its active metabolites PR104H and PR104M. In addition, in preclinical models, sorafenib has been demonstrated to increase the degree of hypoxia in tumors following treatment. - Non-overlapping toxicity. PR104 and sorafenib do not share major toxicities. It is anticipated that both drugs can be administered at their full single agent dose when used in combination. - Aldo-keto reductase 1C3 (AKR1C3). HCC has been shown to express high levels of AKR1C3 which should lead to selective activation of PR104 within both hypoxic and oxic HCC cells. - Preclinical data. The use of sorafenib and PR104 alone and in combination in a hepatocellular carcinoma model demonstrates activity of PR104 as a single agent and increased activity when PR104 and sorafenib are used in combination. The current study will provide an estimate of the activity of PR104 in subjects with HCC. This information will prove valuable in defining the future clinical development of PR104, and in determining if PR104 has sufficient activity in HCC to warrant a larger phase III registration study in this indication. Primary objectives - Phase I: Determine the maximum tolerated dose (MTD) of PR104 when used in combination with standard dose sorafenib - Phase II: Estimate the response rate (RR) of PR104/sorafenib [Note: Phase II was never initiated] Secondary objectives - Evaluate survival - Evaluate Progression Free Survival (PFS) - Evaluate time to progression (TTP) - Evaluate safety - Evaluate the pharmacokinetics (PK) of sorafenib, PR104 and PR104 metabolites - Collect diagnostic biopsy samples for the determination of aldo-keto reductase 1C3 - Collect plasma samples for assessment of potential biomarkers of tumor hypoxia
This is a single arm phase II trial of Gemcitabine and Oxaliplatin (Gem-Ox) with Erlotinib (Tarceva) for the treatment of hepatocellular carcinoma (HCC) and biliary tree cancer (BTC) patients with platelet counts 100,000/µL. The purpose of this study is to determine the tumor control rate following treatment with GEM-OX combined with Tarceva in patients with HCC. Tumor control rate is defined as the percentage of patients achieving a complete response, partial response, or stable disease at 24 weeks following treatment.
Phase 1 Evaluate the safety and tolerability of RAD001 in combination with sorafenib in patients with advance hepatocellular cancer (HCC) and to determine the maximum tolerated dose (MTD) Phase 2 To estimate the treatment effect as a measure of anti-tumor activity in terms of Time to Progression (TTP) of the combination of RAD001 plus sorafenib, at the MTD, as compared to sorafenib alone
Histone deacetylase inhibitors (HDACi) like LBH589 have recently been established as novel potent anti-cancer agents for solid and hematologic malignancies. Several pre-clinical reports have shown a good anti-tumoral activity of different HDACi on human or murine HCC models. These compounds, e.g. Trichostatin A, SAHA, MS-275 and others, have been shown to induce apoptosis in HCC cells and to inhibit growth of HCC by inhibiting proliferation and tumor-related angiogenesis in vivo. Furthermore, HDACi sensitize HCC in a synergistic manner to other forms of cytotoxic stimulation, e.g. by conventional chemotherapeutic drugs or TRAIL-mediated apoptosis. It has also been shown that the combination of HDACi with various kinase inhibitors like sorafenib, erlotinib or others, promotes the anti-tumor efficacy of single agents. Based on the investigators' own previous experiences with different HDACi and LBH589 in preclinical HCC models, a strong anti-proliferative and pro-apoptotic as well as an anti-angiogenic effect will be expected by combining LBH589 with an existing sorafenib treatment. It is assumed that this combination will prolong overall survival and time-to-progression with lowered adverse effects in HCC patients.
The primary objective of the study is to select the dose of AVE1642 to be administered in patients with liver carcinoma not eligible for local treatment. The secondary objectives of the study are: - To evaluate the safety profile of AVE1642 as single agent and the safety profile of combinations with other anti-cancer therapies of interest in liver carcinoma , including detection of immunogenicity. - To evaluate pharmacokinetics and pharmacodynamics profiles of AVE1642 as single agent or any PK interactions when given in combination with other anti-cancer therapies. - To assess the preliminary clinical activity in terms of response rate (Complete response + Partial response), duration of responses, stabilisation rate and duration of stabilisation, according to RECIST criteria. - To assess the biological activity at the tumor level.
This phase II trial studies how well giving sunitinib malate together with capecitabine works in treating patients with unresectable or metastatic liver cancer. Sunitinib malate 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 capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sunitinib malate together with capecitabine may kill more tumor cells
Adult liver cancer is the third leading cause of cancer deaths worldwide. The major risk factor for liver cancer is hepatitis B virus (HBV) infection. The purpose of the study is to sequence the HBV genome in patients with chronic HBV infection, and in patients with liver cancer resulting from chronic HBV infection. The goal is to identify mutations in the HBV genome that predisposes these high risk individuals to the development of liver cancer.