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Carcinoma, Hepatocellular clinical trials

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NCT ID: NCT02715492 Not yet recruiting - HCC Clinical Trials

Role of (LMWH) in Prevention of Thromboembolic Complication After (TACE) in Hepatocellular Carcinoma.

Start date: October 2018
Phase: Phase 3
Study type: Interventional

Hepatocellular carcinoma (HCC) is a major health problem worldwide, and most cases are inoperable because of late presentation and underlying cirrhosis. It represents the fifth most common tumor in the world and the third most frequent cause of mortality amongst patients with cancer. Due to the worldwide difficulties in finding liver for transplantation, hepatic resection (HR) represents the main stay of curative treatment for patients with HCC. Transcatheter arterial chemoembolization (TACE) is widely used as alternative treatments for unresectable HCC or for patients not eligible to be operated on . TACE also could be an adjuvant therapy for resectable HCC patients after hepatectomy, which could prevent recurrence and improve long-term survival .

NCT ID: NCT02702323 Not yet recruiting - Clinical trials for Hepatocellular Carcinoma

Treatment Patients With Pulmonary Metastasis of Liver Cancer With Apatinib Combination With TACE: a Clinical Study

Start date: March 2016
Phase: Phase 2/Phase 3
Study type: Interventional

This study mainly evaluate the clinical effect of Apatinib in the treatment of patients with pulmonary metastasis of hepatocellular carcinoma.Half of participants will receive Apatinib and transcatheter arterial chemoembolization (TACE) therapy in combination,while the other half will receive TACE therapy alone.

NCT ID: NCT02640924 Not yet recruiting - Clinical trials for Carcinoma, Hepatocellular

Proton Radiotherapy Versus Radiofrequency Ablation for Patients With Medium or Large Hepatocellular Carcinoma

Start date: January 2016
Phase: Phase 3
Study type: Interventional

Hepatocellular carcinoma (HCC) is one of the most common cancers in Taiwan, where chronic viral hepatitis is common. Patients with HCC typically have impaired liver function because of virus- or alcohol- induced cirrhosis and viral hepatitis, and only approximately 20% of them are appropriate candidates for surgery. The 5-year overall survival for patients treated by surgery is approximately 30%-70%. For those not treated with surgery, liver function affected by an underlying liver disease has a strong influence on clinical outcomes, and complicates treatment strategies further than for other tumors. Maximal preservation of normal liver volume and function is an important consideration in the choice of treatment. Proton beam has been applied to HCC treatment in Japan for longer than a decade, and several retrospective results showed excellent 3-5 years local control rate ranging from 85-95% and nearly no major complications. The investigators also retrospectively reviewed 75 index tumors sized 3.1-7.0cm in 70 patients receiving multiple-electrode radiofrequency ablation with switching controller (ME-SWC RFA) treatments in the period between 1 January 2009 and 31 December 2011 (Oral report in Taiwan Digestive Disease Week, October, 2012). Estimated 1-, 2-, and 3-year cumulative overall survival rates and local control rates were 94%, 85%, 81% and 89%, 83%, 67%, respectively. Since ME-SWC RFA is the present one of standard modalities for non-surgery, moderate to larger (3-7 cm) HCC, and based on retrospective studies the local control rate of proton therapy was better than radiofrequency ablation, this prospective trial is aimed to compare the effects of these two modalities in 3-7 cm HCC patients who are not candidates for surgery or refuse surgery. This prospective study has high possibility to confirm the role of proton beam in HCC. Along with the clinical trial, the investigators will also use next generation sequencing (NGS) to exam gene expression profile of tumor samples and find out candidate genes related to local control, intrahepatic control (treatment out-field control in liver), regional lymph node relapse, distant metastasis, and treatment response in HCC.

NCT ID: NCT02631499 Not yet recruiting - Clinical trials for Carcinoma, Hepatocellular

Efficacy Study of TACE to Treat Hepatocellular Carcinoma After Operation

Start date: December 2015
Phase: Phase 4
Study type: Interventional

This study is designed to prospectively evaluate whether post-hepatectomy adjuvant transcatheter arterial chemoembolization (TACE) is effective in reducing early recurrence in HCC patients with preoperative CTC ≥2.

NCT ID: NCT02587884 Not yet recruiting - Clinical trials for Hepatocellular Carcinoma

Anti-recurrence Treatment of Postresection on HCC Patients With MVI Presence and Over-expression of ASPH

Start date: n/a
Phase: Phase 1
Study type: Interventional

The aim of this study is to explore the effect of Transarterial Chemoembolization (TACE) on the prognosis of patients with microvascular invasion presence(MVI) and overexpression of Aspartate-β-hydroxylase(ASPH).

NCT ID: NCT02564666 Not yet recruiting - Clinical trials for Hepatocellular Carcinoma

The Effect of Telephone Counseling on the Compliance and Satisfaction for Advanced HCC Patients Receiving Sorafenib

SORATEL
Start date: October 2015
Phase: N/A
Study type: Interventional

Sorafenib is an oral multikinase inhibitor with antiproliferative and antiangiogenic effects used as systemic treatment in patients with unresectable hepatocellular carcinoma. Although sorafenib has demonstrated many clinical benefits in patients, its adverse cannot be ignores. This drug occasionally causes severe adverse events (AEs), which include hand-foot skin reaction (HFSR), hypertension, diarrhea, anorexia, fatigue, weight loss, and so on. Although most adverse events are reversible, they can significantly impact a patient's quality of life and occasionally result in dose reduction or discontinuation of therapy Patients are also more likely to remain on treatment if they are guided over the difficult initial 4~6wks of therapy during which time the development of adverse events following sorafenib treatment initiation are most likely to occur. Patient education, proactive management and establishing and maintaining open communication between patients and the nurse are crucial to the effective management of these adverse events. This study design is a randomized controlled trial and 64 patients will be randomized to one of 2 groups in a 1:1 ratio. 32 patients will be enrolled into the controlled group and the rest of 32 patients will be enrolled into the intervention group. The intervention group will be received the routine telephone calls of six times at intervals of once a week during 10~15 minutes (from a well-trained nurse) The purpose of this study is to confirm whether an effective intervention that telephone counseling and education by a nurse can increase drug compliance for patients with HCC who is taking Sorafenib and is to use for developing individual educational program as a fundamental data that can be applied for patients taking Sorafenib after investigating patient satisfaction by "The Satisfaction with information about Medicines Scale(SIMS)" tool.

NCT ID: NCT02561546 Not yet recruiting - Diabetes Clinical Trials

p53 Gene Therapy in Treatment of Diabetes Concurrent With Hepatocellular Carcinoma

Start date: December 2015
Phase: Phase 2
Study type: Interventional

An open-labeled phase II study to investigate preliminary efficacy using p53 gene therapy in treatment of diabetes concurrent with hepatocellular carcinoma (HCC).

NCT ID: NCT02523053 Not yet recruiting - Clinical trials for Hepatocellular Carcinoma

Effect of Intraoperative Controlled Release 5-Fluorouracil Therapy on Recurrence in Hepatocellular Carcinoma Patients

Start date: April 2016
Phase: N/A
Study type: Interventional

The aim of this study is to confirmed the role of intraoperative controlled release 5-Fluorouracil therapy in the prevention of recurrence after surgery for HCC patients with high risk of preoperative prediction of microvascular invasion.

NCT ID: NCT02507882 Not yet recruiting - Clinical trials for HCV Infection ( Genotype 4)

Impact of IL-28B rs12979860 and rs4803217 Gene Polymorphisms Associated With miRNAs Deregulation on HCV-related Hepatocellular Carcinoma

Start date: January 2016
Phase: N/A
Study type: Interventional

Hepatocellular carcinoma (HCC) is the third leading cause of cancer deaths worldwide as well as in Egypt. Despite improvements in HCC therapy, the prognosis for HCC patients remains poor. Today molecular, genomic and epigenomic aberrations in tumors are being deeply investigated. Many biomarkers were associated to HCC onset, and they could be useful for clinicians, but all show some limitations and no one is so early to predict the HCC onset. It is estimated that 51.5% of HCC cases can be attributed to HCV infection. Moreover, there is a large occult reservoir of HCV caused chronic liver disease in approximately 9 % in the Egyptian with estimated 6 million HCV chronic infections and estimated 150 000 new infections per year. Among them, we have to mention the polymorphism of IL28B gene rs12979860 C/T. and rs 4803217. The IL-28B gene encodes interferon-lambda 3 (IFN-λ3), which belongs to the type III IFN family. IFN-λ interacts with a transmembrane receptor inducing a potent antiviral response. In experimental model of HCV type III IFN was able to inhibit viral replication. IL-28B polymorphisms are linked to the efficiency of the inflammatory process during HCV infection, and to the mechanisms that HCV adopts to escape by innate and adaptive immunity. During the last years, a number of studies have assessed the association between the IL-28B polymorphisms and risk of HCC and liver cirrhosis (LC) occurrence in various populations; however, results obtained are still inconclusive. Interestingly, some polymorphisms located at the 3' untranslated region (UTR) of IL28B, e.g. rs 4803217, seem to interfere with the binding of miRNA, to date recognized as important post-transcriptional regulators. In the last years miRNAs acquired a growing relevance as potential biomarkers for several diseases including cancer, and many researches are focusing on understanding their role in cancer. Thus the objectives of the current proposal are to determine through investigating a cohort of 405 patients, whether IL28B rs12979860 and rs4803217 polymorphisms are associated to the risk of HCC in chronic hepatitis C (CHC) patients and, above all, to identify their role as predictor marker of HCC in CHC, when associated to miRNAs modulation. Data obtained by our work could be helpful in HCC diagnosis, thus leading to the improvement of the patients prognosis. The proposed activities are going to be implemented through a partnership us as Egyptian Liver Research Institute and Hospital (ELRIAH)- Dakhlya- Egypt and Non- Egyptian Partners.

NCT ID: NCT02448056 Not yet recruiting - Clinical trials for Carcinoma, Hepatocellular

MiRNA as a Diagnostic and Prognostic Biomarker of Hepatocellular Carcinoma

Start date: June 2015
Phase: N/A
Study type: Observational [Patient Registry]

Hepatocellular carcinoma (HCC) is the most common primary liver cancer and the third leading cause of cancer-related death worldwide. Treatments of HCC include surgical resection, local therapies such as radiofrequency ablation and ethanol injection, transarterial chemoembolization, sorafenib and best supportive care. However, even after successful treatment such as surgical resection, most patients suffered from recurrence or progression of the tumor. Because clinical staging systems cannot precisely predict the outcome of patients with HCC, it's of great interest to search serum biomarkers for HCC. Among them, alpha-fetoprotein (AFP) is the most well-studied. However, the applicability of AFP for HCC after surgical resection of tumor or after local therapy is still uncertain. MicroRNAs (miRNAs), 17- to 25-nucleotide non-coding RNAs, are frequently dysregulated in cancer and emerging as novel non-invasive biomarker for cancer screening, diagnosis, monitor therapy efficacy and predict prognosis. MiRNAs are stably expression in serum as their resistance to endogenous RNase and easily storage with high stability. Several studies have shown abnormal expression of human serum miRNAs in many cancers such as liver, colorectal, and pancreatic cancer. The sensitivity of miRNA as a diagnostic biomarker of HCC could be upto 80%. Using miRNA arrays can generate miRNA signatures and improve the sensitivity and specificity of biomarker for tumor diagnosis and prognosis prediction. In this study, the investigators will establish an miRNA platform as biomarkers for diagnostic or prognostic tools of HCC. The investigators will also compare the miRNA expression level before and after treatment in the serum and correlate the miRNA expression between serum and tumor tissue.