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Hepatocellular Carcinoma clinical trials

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NCT ID: NCT02743065 Recruiting - Clinical trials for Hepatocellular Carcinoma

HepaSphere Chemoembolization in Advanced HCC Patients: Safety & Efficacy Registry in China

SUPER-China
Start date: September 2016
Phase:
Study type: Observational

The purpose of this multicenter registry is to gather the safety, efficacy and survival data in advanced HCC patients treated with HepaSphere in China in order to evaluate the application of HepaSphere deTACE in treating advanced HCC patients

NCT ID: NCT02733809 Recruiting - Clinical trials for Hepatocellular Carcinoma

Mechanism of Sorafenib Resistance in Patients With Advanced Hepatocellular Carcinoma

Start date: January 2014
Phase: Phase 4
Study type: Interventional

It has been shown previously that gene expression profiling signature (a set of dysregulated genes) can be used for molecular classification, diagnosis, and prognosis of several types of cancers. In This study the hypothesise that resistant tumor may be due to genetic mutations and/or other alternative pathways that could be the reason to overcome the Sorafenib and still proliferate. Primary objectives To evaluate the primary and secondary potential mechanisms by which HCC patients on Sorafenib treatment would be resistant to therapy and also identify the favorable genetic makeup of patients responding to treatment. Measures of primary outcome: - cDNA microarray analysis on the MAP kinase pathway. - mRNA quantification of genetic expression (RT-PCR) for identification of upregulated genes, and confirmed by corresponding proteomic testing (by Mass Spectroscopy) in the serum for potential serum markers. Secondary Objectives Progression free survival: Time to disease progression in patients in Saudi Arabia with HCC receiving Sorafenib: [defined as time, in weeks, from the baseline visit to progression of the disease or death from any cause] will be diagnosed using the RECIST criteria based on a trimestrial abdominal CT evaluation. - Survival rates and Predictors of survival: - Survival defined as the time from baseline visit to death from any cause [in weeks]. - Variables identified in multivariate regression analysis from overall treated patients independently associated with survival till study completion or death. Justification and Value to the Kingdom Sorafenib in the treatment of advanced HCC is a recent development. Since the only current effective treatment for advanced HCC is resection or transplantation and the list for these procedures are ever-growing due to the confounding effect of the lack of infrastructure in the Kingdom, selecting treatment for patients who are more likely to respond to Sorafenib treatment The Long-Term Comprehensive National Plan for Science, Technology and Innovation will help to reduce costs of managing HCC. Among Saudi Arabia population, there are a unique set of patients here (e.g. non-alcohol related HCC, genotype 4 HCV patients and genotype D HBV patients, high percentage of obese patients i.e. NASH) which is different from other parts of the world. There is increasing incidence of HCC in Saudi Arabia. Due to available expertise in management of HCC patients in the participating institutions in the study, this project will represent a bridge for the transfer of technology so that our research staff and doctors will have more expertise in carrying out these techniques independently. This study will also run in parallel to the on-going initiative to start a HCC biobanking establishment which will provide the samples needed to carry out our genetic studies in future. Finally, since the use of Sorafenib (at present, the only approved treatment for advanced HCC) in the treatment of advanced HCC is a new field, the findings of our study will have important implications in the management of HCC, both locally and internationally. HCC is the third most common cancer in Saudi Arabia. In 2001, HCC was the second most common cancer affecting Saudi males and the eighth most common cancer affecting females. Most of patients (90%) present at a more advanced stage when symptoms prevail. Given the high prevalence of HCC in the Kingdom, it is pertinent to study why some patients are resistant to Sorafenib compared to others. Elucidation of the differences in mechanisms among responders and non-responders to Sorafenib therapy will enable physicians to make better decisions in terms of treating Saudi HCC patients.

NCT ID: NCT02730611 Completed - Clinical trials for Hepatocellular Carcinoma

Metabolic Syndrome, Bile Acids, Hepatocellular Carcinoma and Cholangiocarcinoma

METSLIVER
Start date: March 2016
Phase:
Study type: Observational

Increasing rates of highly malignant hepatocellular carcinoma (HCC) and biliary tract cancers (GBTC) observed in Western populations may be related to obesogenic lifestyle factors and their metabolic consequences, such as metabolic syndrome (MetS), inflammation and altered production of bile acids (BA). Such lifestyle behaviours may induce changes in the gut microflora which in turn affect BA profiles, increasing their carcinogenicity. Some elevated BA may be oncogenic in exposed liver, bile ducts and gall bladder. Vertical sleeve gastrectomy may change bile acid composition. The aims of this study are: 1. whether specific presurgical bila acid profiles are predictive of efficacy of vertical sleeve gastrectomy, reflective of liver function and metabolic dysfunction; 2. whether specific presurgical bile acid profiles are predictive of the efficacy of sleeve gastrectomy

NCT ID: NCT02729506 Recruiting - Clinical trials for Hepatocellular Carcinoma

Transarterial Radioembolization Versus Chemoembolization for the Treatment of Hepatocellular Carcinoma

Start date: January 2016
Phase: Phase 4
Study type: Interventional

Hepatocellular Carcinoma (HCC) is a primary liver cancer. It is the 6th most common malignancy and the 3rd killers of all tumors worldwide with an incidence of 626,000 new patients a year. The intermediate stage of HCC is controlled by radiological interventions such as Transarterial Chemoembolization (TACE) or Radioembolization. Although 90Y radioembolization is increasingly being used in clinical practice, there is no high quality clinical evidence to justify this. To date, no prospective studies have been performed comparing both treatment modalities (TACE vs 90Y) in a randomized setting. This randomized controlled trial is designed to prospectively compare TACE and 90Y for treatment of patients with unresectable (BCLC intermediate stage) HCC. This will be done by recruiting 75 patients in each arm from. Investigators will compare between the two groups the time to progression (TTP) as the primary outcome and also examine time to local progression (TLP) as well as other factors like overall survival, response to therapy, toxicities and adverse events, quality of life and treatment-related costs.

NCT ID: NCT02728193 Completed - Clinical trials for Hepatocellular Carcinoma

Standard Treatments of Very-early Stage Hepatocellular Carcinoma

Start date: December 2012
Phase: N/A
Study type: Interventional

The aim of our study was to elucidate the difference in the rates of complication, hospitalization days, medical expenses, MRI showed that the degree of tumor necrosis, and overall survival rates of the therapies between PEI, MVA and RFA, and make the standard for minimally invasive treatment of very early stage HCC.

NCT ID: NCT02727673 Completed - Clinical trials for Hepatocellular Carcinoma

Relationship Between Circulating Tumor Stem Cells and the Clinical Pathology

Start date: December 2012
Phase: N/A
Study type: Observational

The aim of this study is to establish a platform of detecting and sorting circulating tumor stem cells from peripheral blood in HCC patients; to investigate the relationship between circulating tumor stem cells and their effects on postoperative recurrence and metastasis, in order to provide a new therapeutic target for hepatocellular carcinoma treatment.

NCT ID: NCT02727309 Recruiting - Clinical trials for Hepatocellular Carcinoma

A Study of Second-line Treatment With Apatinib After TACE in Advanced Hepatocellular Carcinoma Patients

Start date: October 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This study is designed to evaluate the efficacy and safety of TACE combined with apatinib in treating advanced hepatocellular carcinoma. The primary endpoint is progression-free survival (PFS), 3-month PFS, 6-month PFS and 1-year PFS.

NCT ID: NCT02725996 Not yet recruiting - Clinical trials for Hepatocellular Carcinoma

By Using Adoptive Transfer of Autologous NK Cells to Prevent Recurrence of Hepatocellular Carcinoma After Curative Therapy

Start date: April 2016
Phase: Phase 2
Study type: Interventional

To prove that the efficacy and safety of 'NK group' is superior to 'non-treatment group(Control group)' in patient undergone curative resection(RFA or operation) for hepatocellular carcinoma in China.

NCT ID: NCT02718235 Not yet recruiting - Clinical trials for Hepatocellular Carcinoma

Prospective, Multicenter HCCIS Evaluation Study

HCCIS
Start date: June 2016
Phase: N/A
Study type: Observational

With this prospective, multicenter trial the investigators aim to establish the Hepatocellular Immune Score (HCCIS), a score that has been developed in a retrospective study, as a new tool for risk stratification of patients after resection of hepatocellular carcinoma that can be widely used in the clinical practice. The investigators expect to show that this score is a prognosticator for overall survival and also disease free survival. Further, it should be demonstrated that the HCCIS is a risk stratification tool that is independent from clinical or descriptive parameters. Additionally, the investigators plan to elucidate that the respective HCCIS risk groups are not only different with respect to immunological infiltration but are also different with respect to tumor biology. The finding, that tumors of the respective risk groups show different tumor biology leads to the assumption that different therapy strategies need to be applied. Therefore, in a translational approach we aim to build up a data base with HCC tumor organoids and test the effect of CD8+IL-33+ effector-memory cells on HCC tumor organoids of the respective HCCIS risk groups.

NCT ID: NCT02716012 Active, not recruiting - Clinical trials for Hepatocellular Carcinoma

First-in-Human Safety, Tolerability and Antitumour Activity Study of MTL-CEBPA in Patients With Advanced Liver Cancer

OUTREACH
Start date: March 1, 2016
Phase: Phase 1
Study type: Interventional

MNA-3521-011 study is a multi-centre, open-label, first-in-human, phase 1a/b clinical study dose/dose frequency escalation followed by a cohort expansion part. MTL-CEBPA is administered as monotherapy or in combination with sorafenib to patients with advanced hepatocellular carcinoma and cirrhosis of the liver. All participants will be considered unsuitable for liver tumour resection and/or is refractory to radiotherapy and other loco-regional therapies. MTL-CEBPA consists of a double stranded RNA formulated into a SMARTICLES® liposomal nanoparticle and is designed to activate the CEBPA gene.