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Carcinoma, Hepatocellular clinical trials

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NCT ID: NCT03163992 Completed - Clinical trials for Hepatocellular Carcinoma

Pembrolizumab in Advanced Hepatocellular Carcinoma as Second-line Treatment After Failure of Sorafenib

Start date: December 26, 2017
Phase: Phase 2
Study type: Interventional

This is a single-arm, single-center, open-label trial of pembrolizumab (MK-3475) in subjects with advanced hepatocellular carcinoma as second-line treatment after failure of sorafenib. Approximately 60 subjects will be enrollment to evaluate the efficacy and safety of pembrolizumab. Enrollment will begin with all subjects without regard for PD-L1 expression status. An evaluable specimen for PD-L1 status must be available and confirmed prior to enrollment. All study subjects will be evaluated every 6 weeks (+/- 7 days) following the date of IP drug adminstration for the first 12 months and every 12 weeks (+/- 7 days) thereafter until progression of disease is documented with radiologic imaging (computed tomography or magnetic resonance imaging). The primary efficacy endpoint is ORR (objective response rate) per RECIST 1.1.

NCT ID: NCT03163186 Completed - Hepatic Carcinoma Clinical Trials

Transradial Versus Transfemoral Arterial Access in Liver Cancer Embolization: Randomized Trial to Assess Patient Outcomes and Satisfaction (BEST ACCESS Trial).

ACCESS
Start date: December 1, 2015
Phase: N/A
Study type: Observational

To evaluate the safety, advantages, and appropriateness of performing transarterial hepatic emobolization of liver cancer via arterial access from the radial artery versus conventional transfemoral arterial access. The procedures that will be followed utilizing arterial access include transarterial chemoembolization (TACE), specifically performed for hepatocellular carcinoma, and transarterial embolization (TAE) which is performed for types of liver tumors such as carcinoid tumors or liver metastases.

NCT ID: NCT03162198 Completed - Clinical trials for Hepatocellular Carcinoma

Frequency of Circulating Tumor Cells (CTCs) and Amount of Cell-free DNA (cfDNA) in Cirrhotic Patients With Hepatocellular Carcinoma (HCC)

Start date: May 15, 2017
Phase:
Study type: Observational

All consecutive patients with liver cirrhosis, with clinical and imaging features suggestive of Hepatocellular Carcinoma (HCC) attending the Department of Hepatology, Institute of Liver and Biliary Sciences (ILBS) from February 2017 to December 2018 will be evaluated for inclusion.Based on the previous years data of HCC patients admitted to ILBS. Cirrhotic patients aged 18-70 years, with HCC proven by typical radiological features of arterial enhancement and delayed wash-out, on one or both of dynamic Computerized Tomographic or dynamic Magnetic Resonance Imaging (MRI), as per updated American Association for the Study of Liver Disease (AASLD) guidelines (details in appendix1). Age and gender matched patients with cirrhosis, but without HCC, seen during the same study period will serve as controls. Patient characteristics, etiology of cirrhosis, and liver function parameters will be noted. Investigator will stage the included patients as per the Barcelona Cancer of Liver Cancer (BCLC) criteria (details in appendix1). Investigator will then estimate Circulating Tumor Cells (CTC) and cfDNA in peripheral blood samples of the patients and controls.

NCT ID: NCT03156582 Completed - Clinical trials for Hepatocellular Carcinoma

Impacts of the α-fetoprotein (AFP) Score in Real Life for Patient Selection for Liver Transplantation (LT) for Hepatocellular Carcinoma (HCC)

Impact AFP
Start date: April 1, 2016
Phase:
Study type: Observational

This is a French multicentric retrospective study on intention-to-treat comparing results of LT for HCC before and after the use of the AFP score. The investigators hypothesis is a better respect of the Biomedicine Agency (the French national transplantation agency) criteria since the general application of this score in March 2013. The aim of this study is to determine if the tumoral characteristics at the time of LT are improved and if it modified the patients'outcome.

NCT ID: NCT03146234 Completed - Clinical trials for Hepatocellular Carcinoma

CAR-GPC3 T Cells in Patients With Refractory Hepatocellular Carcinoma

Start date: March 17, 2017
Phase: N/A
Study type: Interventional

This study is designed to determine the safety and efficacy of CAR-GPC3 T cells in patients with relapsed or refractory hepatocellular carcinoma. Single or multiple doses of GPC3-targeted CAR T cells will be given to subjects with unmet medical needs for which there are no effective therapies known at this time.

NCT ID: NCT03140332 Completed - Clinical trials for Hepatocellular Carcinoma

Contribution of the Perfusion Scanner in the Prediction of the Tumor Control of Patients With Hepatocellular Carcinoma Treated With Sorafenib.

HCC-CTPerf
Start date: February 27, 2017
Phase: N/A
Study type: Interventional

Hepatocellular carcinoma (HCC) is a hypervascular tumor. The reference treatment of advanced forms of stage C according to the Barcelona classification (BCLC C) is sorafenib, a multi-target tyrosine kinase inhibitor with predominant anti-angiogenic action. In order not to underestimate the efficacy of sorafenib, scannographic evaluation of the tumor response should be performed with mRECIST criteria that are significantly better correlated with survival. These criteria take into account the tumor size and also the modification of the tumor contrast enhancement after anti-angiogenic treatment. It seems appropriate to evaluate tumor control rather than tumor response since sorafenib is more stable than tumor response. This evaluation will be made according to the mRECIST criteria after 3 months of treatment since the progression-free survival is of the order of 3 to 4 months. The determination of early predictive criteria for the response to sorafenib would optimize the management of advanced HCCs. Indeed, sorafenib only improves overall survival by 3 months in selected patients, and with undesirable effects and a significant cost. Predictive biological criteria have already been studied, such as alpha foeto-protein (AFP), whose early decrease with sorafenib is associated with better overall survival. The same applies to the early reduction at 4-6 weeks of tumor arterial contrast according to mRECIST criteria. The perfusion scanner appears to be an accessible and reproducible choice imaging technique for assessing tumor vasculature. In metastatic kidney cancers, it was demonstrated that some criteria for tumor perfusion prior to treatment with sorafenib were predictive of better control of the disease and even a better tumor response according to the RECIST 1.1 criteria. The determination of pre-therapeutic tumor perfusion criteria in order to predict tumor control or even overall survival has never been studied in advanced CHCs. On the other hand, an early variation in the criteria for tumor perfusion under treatment would tend to be correlated with the tumor response and even with overall progression-free survival. Therefore, the study of tumor vascularization by the perfusion scanner could make it possible to demonstrate early predictive criteria for tumor control under sorafenib in order to optimize the management of patients with advanced HCC.

NCT ID: NCT03138031 Completed - Clinical trials for Hepatocellular Carcinoma Non-resectable

Percutaneous Ethanol Alcohol Injection for the Large and Unresectable Hepatocellular Carcinoma

Start date: May 1, 2017
Phase: N/A
Study type: Interventional

Assessment of the long-term outcome of percutaneous ethanol alcohol injection (PEI) for the large and unresectable hepatocellular carcinoma: single center non-randomized trial.

NCT ID: NCT03113955 Completed - Clinical trials for Localized Hepatocellular Carcinoma

STOPPER CHINA:With Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma

Start date: October 24, 2017
Phase: N/A
Study type: Interventional

A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma

NCT ID: NCT03109886 Completed - Clinical trials for Hepatocellular Carcinoma

Study of Milciclib in Patients With Unresectable/Metastatic Hepatocellular Carcinoma

Start date: July 12, 2017
Phase: Phase 2
Study type: Interventional

The primary aim of this exploratory study is to test the safety and tolerability of milciclib when administered orally at 100 mg in patients with recurrent or metastatic Hepatocellular Carcinoma. The evaluation of the efficacy profile is a secondary objective of the study. Moreover, markers expression in tumor cells and plasma will be studied and described in association with the clinical outcome. Eligible patients will receive milciclib orally on a daily schedule for 4 consecutive days a week in a 4-week cycle (4 days on/3 days off x q4 wks) for a total of 12 weeks (i.e. 3 cycles) unless patient refusal, consent withdrawal, Investigator's decision, unacceptable toxicity or death whichever occurs earlier. At the end of Cycle 3, treatment will be stopped, and based on the results of the tumor assessment performed on Day 90 (±3 days) from treatment start, patients will be followed as here below detailed: - patients with Complete Response (CR)/Partial Response (PR)/Stable Disease (SD) will be followed for safety until 30 days from last dose intake (or until a new anticancer therapy starts, whichever occurs earlier) and will be assessed for efficacy in the follow-up period up to Day 180 from treatment start; - patients with progressive disease will be followed only for safety until 30 days from last dose intake (or until a new anticancer therapy starts, whichever occurs earlier). After the completion of three cycles, patients who, in the Investigator's judgment, are benefiting from treatment with milciclib, will resume treatment and will remain on study up to Day 180 from treatment start, unless withdrawal criteria are met earlier.

NCT ID: NCT03088423 Completed - Clinical trials for Carcinoma, Hepatocellular

HCC Response Assessment by MRI After SBRT

Start date: October 1, 2011
Phase: N/A
Study type: Observational

The aim of this work was to describe SBRT different presentations, to study predictive factors for tumor responses following treatment, and to compare tumor response assessments according to the Response Evaluation Criteria