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Carcinoma, Hepatocellular clinical trials

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NCT ID: NCT03175679 Recruiting - Clinical trials for Hepatocellular Carcinoma

Adoptive Transfer of iNKT Cells for Treating Patients With Relapsed/Advanced HCC

Start date: May 1, 2017
Phase: Phase 1
Study type: Interventional

This study enrolls patients who have relapsed/advanced hepatocellular carcinoma (HCC, BCLC stage C). The HCC tumor relapsed or metastasized through the body after standard treatment or the patients cannot receive standard treatment under current conditions. This research study uses special immune system cells called iNKT cells, a new experimental treatment. The purpose of this study is to find the biggest dose of iNKT cells that is safe and tolerance, to see how long they last in the body, to learn the immunoresponse in the body, to learn the side effects are and to see if the iNKT cells will help people with relapsed/advanced hepatocellular carcinoma (HCC).

NCT ID: NCT03172559 Withdrawn - Clinical trials for Hepatocellular Carcinoma

Radiotherapy Versus no Intervention in Adult Patients With Hepatocellular Carcinoma Not Eligible for Transarterial Chemoembolization or Ablation Prior to Liver Transplant (RADBRI)

RADBRI
Start date: September 2020
Phase: N/A
Study type: Interventional

Liver transplantation (LT) represents the best treatment for patients with selected, early stage hepatocellular carcinoma (HCC). Due to the gap between the number of patients on the waiting list and the available donors, patients with HCC wait ~1 year to be transplanted. While waiting, 25-30% of patients need to come off the transplant list due to tumor progression beyond transplant criteria (extrahepatic disease, vascular invasion or increase in tumor burden beyond enlistment criteria). To try to avoid this progression, patients are treated while waiting with "bridging therapies", mainly transarterial chemoembolization (TACE) and ablation. Around 30% of patients are not eligible for these treatments (.e.g. due to poor liver function). Stereotactic body radiotherapy (SBRT) has been shown to be an effective treatment for advanced HCC in primarily small, single institutional studies and its safety has been reported in cirrhotics. SBRT could be used in patients not eligible to TACE or ablation as a bridge to LT reducing the risk of progression in the waiting list. This study will evaluate if patients with liver cirrhosis and HCC benefit from receiving SBRT while awaiting LT. Patients will be randomized to a treatment arm where they will receive SBRT as a bridge therapy or to a no intervention arm. Outcomes prior and post to transplant will be performed to evaluate the differences between both arms: proportion of patients that do not drop-out of the list (are transplanted), liver decompensation while waiting, perioperative measures in those that are transplanted, time to transplant or drop-out, overall survival, disease-free survival in those that are transplanted in a population of about 330 patients across all sites.

NCT ID: NCT03170869 Terminated - Clinical trials for Subjects Eligible for Liver Transplantation

Bridge to Orthotopic Liver Transplantation (OLT) - Surefire Precision vs Endhole Embolization With DEBTACE

SPEED
Start date: April 12, 2017
Phase: N/A
Study type: Interventional

The purpose of this study will be to prospectively evaluate the outcomes of patients with hepatocellular carcinoma (HCC) who undergo DEB-TACE (drug-eluting bead trans-arterial chemoembolization) with the Surefire Precision Infusion System for intentional effect of down-staging patients to OLT. Patients with HCC and who are considered candidates for liver transplantation but outside Milancriteria and meet the eligibility criteria will be enrolled in the prospective single arm study. Results of the prospective cohort will be compared to matched historical control patients who were previously treated with DEB-TACE, delivered with standard endhole catheters. This includes all patients treated at the University of Colorado since 2009 treated with 100-300 micron beads for whom follow-up is available.

NCT ID: NCT03168152 Withdrawn - Clinical trials for Carcinoma, Hepatocellular

Randomized Trial Comparing Stereotactic Body Radiation Therapy to Microwave Ablation for the Treatment of Localized Hepatocellular Carcinoma

Start date: May 11, 2017
Phase: N/A
Study type: Interventional

This is a randomized phase II study comparing microwave ablation (MWA) and stereotactic body radiation therapy (SBRT) for localized hepatocellular carcinoma (HCC). This trial will be the first prospective comparison of these modalities for the treatment of HCC and will provide critical information regarding which local ablative modality is most appropriate for which patients. This study will also provide important information regarding quality of life and liver function changes following these two different treatment modalities.

NCT ID: NCT03164382 Completed - Liver Cancer Clinical Trials

Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil/Leucovorin Versus Sorafenib in Advanced Hepatocellular Carcinoma

Start date: March 1, 2017
Phase: Phase 3
Study type: Interventional

This trial was designed to investigate whether the survival outcome, response rate and safety of hepatic arterial infusion of oxaliplatin, fluorouracil/leucovorin regimens for patients with Barcelona-Clinic Liver Cancer (BCLC)-C stage hepatocellular carcinoma was superior than those of the standard treatment with sorafenib or not.

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: NCT03151213 Recruiting - Clinical trials for Hepatocellular Cancer

Effect of Pregabalin on the Postoperative Analgesia in RFA of Focal Lesions in the Liver

pregabalin
Start date: May 1, 2017
Phase: Phase 4
Study type: Interventional

The study aimed to investigate the preemptive analgesia efficacy of of preemptive pregabalin for the postoperative pain management after radiofrequency ablation (RFA) of liver cancer.