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Liver Neoplasm clinical trials

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NCT ID: NCT03803436 Recruiting - Neoplasms Clinical Trials

Improving Outcome of Selected Patients With Non-resectable Hepatic Metastases From Colo-rectal Cancer With Liver Transplantation

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

The COLT trial is an investigator-driven, multicenter, non-randomized, open-label, controlled, prospective, parallel trial, aimed at assessing the efficacy (in terms of overall survival: OS) of liver transplantation (LT) in liver-only CRC metastases, compared with a matched cohort of patients bearing the same tumor characteristics, collected during the same time period and included in a phase III Italian RCT on triplet chemotherapy+antiEGFR

NCT ID: NCT03423056 Recruiting - Stomach Neoplasms Clinical Trials

Efficacy and Safety of a Preoperative Aerobic Exercise Program in Patients With Gastrointestinal Cancer.

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

Patients with gastrointestinal cancer often experience physical deconditioning; this could lead to an increased risk of complications, especially when they require major abdominal surgical procedures. It has been suggested that physical training in the preoperative period could improve their condition, reducing the risk of complications. Although this topic has been investigated, it has not been established yet the best short preoperative aerobic exercise program to enhance the aerobic capacity in patients with gastrointestinal cancer who are going to be to surgical primary management, and consequently, to help patients dealing with the physiological stress involved in a surgical intervention. Main objective: To determine the efficacy and safety of a 4 weeks preoperative exercise program in patients with gastrointestinal cancer scheduled for primary surgery. Materials and methods: This is a Phase II single arm clinical trial that will include patients between 45 and 70 years, with confirmed gastrointestinal cancer (gastric, hepatic, colon or rectal cancer), without electrocardiographic abnormalities, and scheduled for primary surgery in 4 weeks or more since recruitment All the enrolled patients will receive a basal aerobic capacity assessment with the 6-minute walk test. Then, two physical therapist will prescribe them a supervised and individualized aerobic training program in 3 sessions per week during 4 weeks. Each session will last 50 minutes and will increase the heart rate target weekly (from 50% to 70% of the maximum heart rate). The aerobic exercise will be carried on a treadmill or in a stationary bicycle. The post intervention aerobic capacity will be measured at week 3 and 4 with the 6-minute walk test. The main efficacy outcome will be peak oxygen consumption (VO2 peak) and the safety outcomes will be exercise-related adverse events and the program adherence. This protocol was approved by the Instituto Nacional de Cancerología's Ethical Board

NCT ID: NCT02632864 Recruiting - Liver Neoplasm Clinical Trials

Feasibility of High Dose PROton Therapy On Unresectable Primary Carcinoma Of Liver: Prospective Phase II Trial

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

The standard treatment of unresectable hepatocellular carcinoma (HCC) is transarterial chemoembolization (TACE) or sorafenib. Though the TACE and the agent showed survival benefit in several randomized phase III trials, the benefit was modest. Recently, radiotherapy (RT), especially conformal and higher dose with the advancement of RT techniques, showed favorable response rate with acceptable local control rate. Based on those promising results, RT was actively applied in HCC who are not indicated with surgery and/or radiofrequency ablation. Many researchers reported that there is a relationship between RT dose and tumor response rate. RT dose, however, is frequently limited because the complications (like radiation induced liver disease (RILD), radiation induced gastro-duodenal toxicity, etc.) are also closely related with higher exposed RT dose. Proton beam has characteristic depth-dose distribution contrast to photon, the "Bragg peak". The advantage of this dose distribution could be more highlighted in HCC management, because of the weakness and maintenance importance of liver function itself in HCC patients. In fact, the superior results of proton beam therapy in HCC were constantly reported in several groups as prospectively as well as retrospectively. In this background, the investigators planned the present study to evaluate the efficacy and safety of proton beam therapy in HCC patients who are not indicated with surgery and/or radiofrequency ablation (RFA).

NCT ID: NCT02599909 Withdrawn - Clinical trials for Hepatocellular Carcinoma

Gut Microbiota in People With Hepatocellular Carcinoma (HCC)

Start date: November 6, 2015
Phase:
Study type: Observational

Background: There are about 100 trillion microbial cells in a person s gut. This is called the human gut microbiota. When this is disrupted, it can lead to many diseases. Studies show that the gut microbiota in people with cancer is different than that found in healthy people. Researchers want to study links between the gut microbiota and the immune system in people with a liver disease called hepatocellular carcinoma (HCC). Objective: To study links between gut microbiota and the immune system in people with HCC. Eligibility: People at least 18 years old with HCC. They must be scheduled to have tumors removed by surgery. Design: - People having surgery for primary liver tumors at the Mount Sinai Medical Center will be screened for this study. - At the initial visit, blood, rectal swabs, urine, and stool will be collected. Participants will answer questions about their medical condition. - Before surgery, blood, rectal swabs, urine, and stool will be collected. This will be done at a routine visit. - When they have surgery, a piece of liver tissue with the tumor will be collected. This will be sent to the National Cancer Institute for tests. - After surgery, blood, rectal swabs, urine, and stool will be collected 3 times. This will be done at routine visits.

NCT ID: NCT02571946 Completed - Liver Neoplasm Clinical Trials

Proton Beam Therapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis

PTHP
Start date: August 2015
Phase: N/A
Study type: Interventional

The standard treatment of advanced hepatocellular carcinoma (HCC) is sorafenib. Though the agent showed clear survival benefit in two randomized phase III trials, the benefit was modest and response rate was just a few percent. Therefore, other loco-regional modalities, like trans-arterial chemo-embolization (TACE), hepatic arterial infusion chemotherapy (HAIC), and radiotherapy (RT) were continuously tried, especially in locally advanced HCC including portal vein tumor thrombosis (PVTT). With the advancement of conformal RT techniques, RT was actively applied in HCC, especially in PVTT combined HCC. Many researchers reported that there is a relationship between RT dose and tumor response rate. RT dose, however, is frequently limited because the complications (like radiation induced liver disease (RILD), radiation induced gastro-duodenal toxicity, etc.) are also closely related with higher exposed RT dose. Proton beam has characteristic depth-dose distribution contrast to photon, the "Bragg peak". The advantage of this dose distribution could be more highlighted in HCC management, because of the weakness and maintenance importance of liver function itself in HCC patients. In fact, the superior results of proton beam therapy in HCC were constantly reported in several groups as prospectively as well as retrospectively. In those background, the investigators planned the present study to evaluate the efficacy and safety of proton beam therapy in HCC patients combined with PVTT.

NCT ID: NCT02557724 Completed - Liver Failure Clinical Trials

Mobilization of Mesenchymal Stem Cells During Liver Transplantation

Start date: September 2015
Phase:
Study type: Observational

To study if the administration of corticoid hinder or enhance the mobilization of Mesenchymal Stem Cells (MSCs) in the peripheral blood during liver transplantation and whether this affects the outcome with respect to graft versus host response.

NCT ID: NCT02471313 Completed - Clinical trials for Hepatocellular Carcinoma

Integrated Imaging Strategy to Phenotype Progression of Liver Tumors During and After Chemoembolization

Start date: June 12, 2015
Phase: Phase 2
Study type: Interventional

Background: - Treatment for liver cancer can include surgery, transplant, and chemotherapy. It can also include other minimally invasive tumor treatments such as transarterial chemoembolization (TACE). TACE treatment for liver cancer helps control the cancer but is not considered a cure. Researchers want to learn more about the effects of TACE on liver tumors and surrounding tissue. To do this, they will use a positive emission test (PET) and a radioactive tracer called [18F] FMISO. Objectives: - To see if [18F] FMISO is useful for evaluating what happens to liver tumors and surrounding tissue after TACE. Eligibility: - People age 18 and older with liver cancer who have been approved to have TACE. Design: - Participants will meet with a study researcher to see if they can take part in the study. - Participants will have TACE under a separate NCI protocol or at a hospital other than the NIH Clinical Center. - Before and after TACE, participants will have a CT and MRI of the abdomen. For these scans, they will lie in a machine that takes pictures of their body. They will also have blood tests and a physical exam. - The [18F] FMISO imaging study will be performed at NIH only. - Participants will have an intravenous catheter placed in their arm (if they do not have one). The [18F] FMISO tracer will be injected. - Participants will have PET-CT scans. Each scan will take about 30 minutes. - Some participants will also have [18F] FMISO and PET-CT scans before TACE. - As part of standard care for TACE, participants will have CT and MRI scans at regular intervals. This will evaluate tumor response.

NCT ID: NCT01542281 Recruiting - Colorectal Neoplasm Clinical Trials

Pre-habilitation to Improve Outcomes in Patients Undergoing Liver Resection for Cancer

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

1. To determine whether a combined nutritional support program and exercise-based prehabilitation is superior to nutritional support alone in increasing functional recovery and reducing post-operative morbidity after surgery for HPB malignancy. 2. To understand which measures of immediate surgical recovery are sensitive to prehabilitation interventions and predict change in later outcome measures.

NCT ID: NCT01217034 Active, not recruiting - Clinical trials for Hepatocellular Carcinoma

Transcatheter Arterial Chemoembolization Therapy In Combination With Sorafenib

TACTICS
Start date: October 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of the combination therapy with Transcatheter Arterial Chemoembolization (TACE) and sorafenib compared to TACE alone in patients with unresectable hepatocellular carcinoma (HCC) who are not candidates for surgical resection or percutaneous ablation therapy.

NCT ID: NCT01180088 Not yet recruiting - Liver Neoplasm Clinical Trials

Effectiveness of Routine Application Of Anterior Approach During Right Hepatectomy

AA
Start date: August 2010
Phase: N/A
Study type: Interventional

The aim of this study was to evaluated the advantages of routine application of the anterior approach in patients scheduled to right hepatectomy or extended right hepatectomy, without infiltration of segment 1, inferior vena cava or main bile duct.