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Carcinoma, Hepatocellular clinical trials

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NCT ID: NCT03908255 Withdrawn - Clinical trials for Hepatocellular Carcinoma

Branched-chain Amino Acid Supplementation for Hepatocellular Carcinoma

BCAA in HCC
Start date: June 1, 2021
Phase: Phase 2
Study type: Interventional

Hepatocellular carcinoma (HCC) is the fifth most common cause of cancer death among men. While several new treatment options have recently become available, they are costly and have a potential for significant, adverse side effects. Many patients diagnosed with HCC also suffer from underlying liver disease, including cirrhosis. As many as 80-90% of patients diagnosed with HCC also have cirrhosis. Protein-energy malnutrition (PEM) in cirrhosis is as high as 65-90% and significantly increases the risk of morbidity and mortality as well as decreased quality of life. Branched-chain amino acid (BCAA) supplementation has been extensively studied for usefulness in liver disease, specifically to treat hepatic encephalopathy to and preserve and restore muscle mass. Maintenance of liver function and prevention of PEM are essential for improving outcomes in patients with HCC. Branched-chain amino acid supplementation in HCC has been studied extensively in China & Japan with multiple studies showing improvements in liver function, progression-free survival, and overall survival. Additionally, patients in treatment groups have shown improvement in quality of life indicators. However, these results have yet to be replicated in the United States. Branched-chain amino acid supplementation may be a safe, low-cost approach to improve survival, liver function indicators, and quality of life for patients diagnosed with HCC. In this study, patients with primary HCC will be randomized to either a treatment group, which will receive standard of care and BCAA supplement or to a control group which will receive standard of care and a maltodextrin placebo. Both groups will receive liver-directed therapy including transarterial chemoembolization (TACE) and thermal ablation. All patients will complete a quality of life survey (FACT-Hep) at each visit.

NCT ID: NCT03803254 Withdrawn - Clinical trials for Hepatocellular Carcinoma

HAIC Plus Lenvatinib and PD-1 Antibody Versus HAIC Plus Lenvatinib for Advanced HCC

Start date: January 3, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus lenvatinib and programmed cell death protein-1 antibody compared with lenvtinib Alone in patients with hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus lenvatinib for advanced hepatocellular carcinoma (HCC)

NCT ID: NCT03791918 Withdrawn - Clinical trials for Hepatocellular Carcinoma

Lenvatinib Plus PD-1 Antibody vs TACE for Intermediate-stage HCC Beyond Up-to-seven Criteria

Start date: January 1, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of lenvatinib combined with PD-1 antibody compared with transarterial chemoembolization (TACE) for patients with intermediate-stage hepatocellular carcinoma (HCC) beyond up-to-seven criteria

NCT ID: NCT03782831 Withdrawn - Clinical trials for Hepatocellular Carcinoma

TACE Plus PD-1 Antibody vs TACE Alone for Unresectable HCC

Start date: December 11, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of transarterial chemoembolization (TACE) combined with programmed cell death protein-1 (PD-1) antibody compared with TACE Alone in patients with unresectable hepatocellular carcinoma (HCC)

NCT ID: NCT03780634 Withdrawn - Clinical trials for Hepatocellular Carcinoma

HAIC Plus PD-1 Antibody vs HAIC Plus Sorafenib for Advanced HCC

Start date: April 1, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of hepatic artery infusion chemotherapy (HAIC) combined with Programmed Cell Death Protein-1 (PD-1) antibody compared with HAIC plus sorafenib in patients with advanced hepatocellular carcinoma (HCC)

NCT ID: NCT03775707 Withdrawn - Clinical trials for Hepatocellular Carcinoma

Lenvatinib Plus PD-1 Antibody for Intermediate-stage HCC Beyond Up-to-seven Criteria

Start date: December 1, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of lenvatinib combined with PD-1 antibody for patients with intermediate-stage hepatocellular carcinoma (HCC) beyond up-to-seven criteria

NCT ID: NCT03748927 Withdrawn - Clinical trials for Hepatocellular Carcinoma

Natural History Study of Children and Adults With Fibrolamellar Hepatocellular Carcinoma

Start date: April 8, 2019
Phase:
Study type: Observational

Background: Fibrolamellar Hepatocellular Carcinoma (FL-HCC) is a rare liver cancer. It usually occurs in young people who have no history of liver disease. Currently the only effective treatment option is surgery that removes the tumor and part of the liver. Researchers want to study the course of the disease to learn more about it. Objective: To collect samples from people with FL-HCC to learn more about the disease and help develop new treatments. Eligibility: People any age with FL-HCC Design: Participants must be enrolled on another NIH protocol. Participants will have at least 1 study visit. They will have: - A medical and cancer history - A physical exam - A review of their symptoms and their ability to do normal activities - Tests to produce images of the body. They may have a scan (CT) that uses a small amount of radiation. Or they may have a scan (MRI) that uses a magnetic field. These will examine the chest, abdomen, and pelvis. - Blood tests Researchers will study previous tumor samples if they are available. If participants come to NIH for visits on other studies, data will be collected about their disease, tests, treatments, and responses. Tumor tissue will be collected if participants are having it taken for a procedure. All other participants will be contacted to collect this data. They will be contacted once a month for 1 year and 2 times a year after that. Participants will be asked to contact researchers when their health changes. They may come in for more tests.

NCT ID: NCT03746249 Withdrawn - Clinical trials for Hepatocellular Carcinoma

Phase II of Lenvatinib Plus PD-1 Antibody for Advanced HCC

Start date: December 17, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of lenvatinib combined with PD-1 antibody in patients with advanced hepatocellular carcinoma (HCC)

NCT ID: NCT03744247 Withdrawn - Clinical trials for Hepatocellular Carcinoma

Lenvatinib Plus PD-1 Antibody Versus Lenvtinib Alone for Advanced HCC

Start date: April 21, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of lenvatinib combined with PD-1 antibody compared with lenvtinib Alone in patients with advanced hepatocellular carcinoma (HCC)

NCT ID: NCT03738111 Withdrawn - Clinical trials for Hepatocellular Carcinoma

Study of TG02 Citrate in Patients With Advanced Hepatocellular Carcinoma

Start date: December 2018
Phase: Phase 1
Study type: Interventional

This is a single-centre, open-label, dose escalation, Phase 1 study. The primary objective is to determine the highest dose of TG02 citrate that can safely be given to patients with advanced hepatocellular carcinoma.