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Liver Cancer clinical trials

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NCT ID: NCT06315361 Active, not recruiting - Diabetes Clinical Trials

DIAbetes and NAFLD

DIANA
Start date: May 20, 2019
Phase:
Study type: Observational

Non-alcoholic hepatic steatosis (NAFLD) is characterised by the excessive accumulation of triglycerides in the liver and is often associated, in the absence of significant alcohol consumption, with insulin resistance and metabolic syndrome with which it shares the most frequent clinical manifestations (hypertension, dyslipidaemia, visceral adiposity, glucose intolerance). Due to the pandemic spread of obesity and diabetes and by virtue of better control of viral hepatitis, NAFLD is the most common cause of liver damage in Western countries with a prevalence of around 20-30% of the general population. The clinical impact of NAFLD in diabetes is considerable and represents a real driver of the major clinical outcomes that impact on the health of the individual, consequently creating a real 'burden of disease' especially in those populations considered to be at higher risk of disease severity. Individuals with diabetes are, in fact, those at greatest risk of developing the clinical sequelae of NAFLD and often do not receive adequate hepatological support and a correct hepatic pathology. In fact, it has been documented in the literature that the presence of diabetes increases the severity of liver damage, bringing the risk of NASH up to 80% and increasing the risk of significant fibrosis to 30-40% of subjects with hepatic steatosis as well as representing an independent predictor for significant fibrosis. Lastly, the increased risk of hepatocarcinoma in subjects with diabetes and NAFLD should not be overlooked, as documented by our group and confirmed in a large Italian case series. In subjects with diabetes, moreover, the presence of NAFLD is not only associated with worse glycaemic control, but also with micro- and macro-vascular complications as well as nephrological and neuropathic complications and increased mortality. Therefore, the possibility of applying the non-invasive fibrosis scores currently available for NAFLD on a large scale, in a population at high risk of progressive liver disease, would make it possible to characterise (a) the true epidemiology of significant fibrosis (F3 or higher); (b) allow primary prevention actions to be carried out by optimising the use of resources or by identifying subjects at greater risk of damage progression; (c) understand, in cases with a long history of disease the true prevalence of clinical outcomes; (d) understand the epidemiology of comorbidities and polypharmacy as a function of significant fibrosis.

NCT ID: NCT05616039 Active, not recruiting - Clinical trials for Hepatocellular Carcinoma

I-FIGS Feasibility Study

I-FIGS
Start date: November 23, 2022
Phase: N/A
Study type: Interventional

Background: Removal of part of the liver (resection) is performed as a treatment for some cancers in the liver. To achieve the best possible outcomes, it is important that the cancer is removed completely (R0 resection) (1). Up to 30-50% patients develop recurrence within 2 years of surgery which could be due to incomplete removal of the cancer (2). Various techniques are used by the surgeons to identify the cancer tissue from the normal liver during the surgery so that it can be removed completely. These include examining with the naked eye, having a feel of the tumour, and performing an ultrasound scan. Even with these techniques it is difficult to identify the exact extent of the cancer. Also, the interpretation of the ultrasound scan can be subjective (3). A robust, objective, real-time navigation technique is required which can differentiate cancer from normal tissue. Indocyanine green (ICG) is a dye which when given through the veins, is taken up and retained by cancer cells in the liver and they appear as fluorescent areas as compared to normal liver which appears dark. This principle can be used to identify the cancerous tissue accurately during the surgery and remove it completely (Indocyanine green Fluorescence Image-Guided Surgery: I-FIGS). It can also potentially detect additional tumours which were not identified before the surgery or during the surgery with standard techniques (4,5). However, there is a lack of good quality evidence on the usefulness of I-FIGS in liver surgery, so this needs to be tested in a large group of patients having liver surgery before any recommendations can be made. Research Aim: This initial study aims to assess whether a larger trial evaluating the role of I-FIGS in complete removal of the cancer tissue is feasible. Investigators will assess if patients are willing to take part in the study and whether they can gather relevant clinical outcome data from them all. Investigators will also gather patients' views about this novel technique and participating in the study. Design and methods: This study will involve 40 patients having planned liver surgery for liver tumour/s recruited from University Hospitals, Plymouth. Patients will be randomly allocated to have I-FIGS plus standard surgery or standard liver surgery alone. Patients in the I-FIGS group will have ICG injection 2-4 hrs prior to surgery (0.03-0.05mg/kg dose) on the day of surgery. The surgical planning will be carried out as per the standard approach using the naked eye and intra-operative ultrasound examination. Once this is all recorded, ICG cameras will be switched on, and the additional findings and change to surgical plan will be noted. Focus groups will explore participants experiences of being in the study. This will inform the design of the future larger trial. Patient public involvement: Investigators have involved patients who have had or are having liver surgery in the development of the study. Their views on the technique, trial procedures and outcome measures have been incorporated. They will continue to be involved and advise on the study. Dissemination: Results will be available via research journals and conferences.

NCT ID: NCT04682847 Active, not recruiting - Clinical trials for Hepatocellular Carcinoma

Radiotherapy With Iron Oxide Nanoparticles (SPION) on MR-Linac for Primary & Metastatic Hepatic Cancers

Start date: November 19, 2020
Phase:
Study type: Observational

There is a high prevalence of hepatic cirrhosis in patients with hepatocellular carcinomas (HCC), or chemotherapy-induced hepatic atrophy or hepatosteatosis in patients with liver metastases associated with high risk of radiation-induced liver disease (RILD) after stereotactic body radiotherapy (SBRT). MRI-SPION radiotherapy planning will facilitate detection and maximize avoidance of residual functionally active hepatic parenchyma from over-the-threshold irradiation thus increasing safety of liver SBRT in patients with pre-existing liver conditions. The investigators have previously demonstrated that liver SBRT with SPECT/CT functional treatment planning utilizing 99mTc sulfur colloid in transplant eligible patients associated with minimal hepatotoxicity and without hastening of advanced hepatic cirrhosis progression while patients await liver transplant. Switching from nuclear medicine to an MR-Linac-SPION based quantitative treatment-planning platform will substantially improve diagnostic accuracy in defining safe volumes of residual functional hepatic parenchyma for liver SBRT planning on MR-Linac.

NCT ID: NCT04597710 Active, not recruiting - Liver Cancer Clinical Trials

Precision Medicine for Liver Tumours With Quantitative Magnetic Resonance Imaging and Whole Genome Sequencing

Precision1
Start date: February 18, 2021
Phase:
Study type: Observational

This will be a prospective, observational, cohort study to determine the impact of integrated diagnostics using quantitative magnetic resonance imaging, whole genome sequencing and digital pathology on intended patient management for liver cancer patients referred for liver resection. Participants with primary or secondary liver cancer will be recruited from Hampshire Hospitals NHS Foundation Trust in Basingstoke or Oxford University Hospitals NHSFoundation Trust in Oxford. The incidence of treatable liver tumours is on the rise globally, driven by obesity, viral hepatitis and metastases from colorectal cancers. Survival rates can be improved with optimised allocation of treatment options including surgical resection, radiofrequency ablation, embolisation, chemotherapy and targeted molecular therapies (including immunotherapy). The key motivation of this study is to help patients access the most suitable treatment combinations, based on integrating clinical, radiological and genomic data. A similar integrated approach, integrating radiology and pathology, has been shown to improve outcomes in breast cancer care. Detailed pathologic analysis of the surgical specimen from breast carcinoma biopsy provides valuable feedback to the radiologist, establishes the completeness of surgical intervention, and generates predictive information for therapeutic decisions. Whole genome sequencing (WGS) has discovered cancer driver mutations and the complex molecular profile of liver cancer. In many metastatic solid tumours, WGS has been used to identify a significant patient population (31%) who present with a biomarker that predicts sensitivity to a drug and lacked any known resistance biomarkers for the same drug. Identifying which patients possess druggable mutations will allow clinicians to make the optimal treatment decisions. The next challenge is integrating WGS into scalable clinical practice

NCT ID: NCT04567615 Active, not recruiting - Clinical trials for Hepatocellular Carcinoma

A Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Liver Cancer Who Have Never Been Treated With Immuno-oncology Therapy After Prior Treatment With Tyrosine Kinase Inhibitors

Start date: February 4, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effectiveness and safety of relatlimab in combination with nivolumab in participants with advanced liver cancer who have never been treated with immuno-oncology therapy, after prior treatment with tyrosine kinase inhibitor therapy.

NCT ID: NCT03744624 Active, not recruiting - Clinical trials for Hepatocellular Carcinoma

Application of 3D Printing in Laparoscopic Surgery of Liver Tumors

Start date: April 28, 2017
Phase: N/A
Study type: Interventional

To explore the utility of personalized 3D printed liver models in planning and navigating laparoscopic resections.

NCT ID: NCT03552718 Active, not recruiting - Breast Cancer Clinical Trials

QUILT-2.025 NANT Neoepitope Yeast Vaccine (YE-NEO-001): Adjuvant Immunotherapy Using a Personalized Neoepitope Yeast-Based Vaccine To Induce T-Cell Responses In Subjects W/ Previously Treated Cancers.

Start date: August 10, 2018
Phase: Phase 1
Study type: Interventional

This is a phase 1 study to evaluate the safety, the Recommended Phase 2 Dose (RP2D), and preliminary efficacy of a personalized neoepitope yeast-based vaccine, YE-NEO-001, in subjects who have completed potentially curative therapy for their solid cancer and who would otherwise be entering a period of surveillance for recurrent disease.

NCT ID: NCT03408665 Active, not recruiting - Liver Cancer Clinical Trials

Stereotactic Body Radiation Therapy (SBRT) Efficiency and Toxicity in Liver Cancer

STEREOLIVER
Start date: March 13, 2019
Phase: N/A
Study type: Interventional

Intervention research involving the human person, phase II, prospective, multicentric, non-randomized and multi-cohort study. The eligibility criteria are broad, on purpose, so every patient, able to be treated by SBRT and unable to participate in another trial (non eligible patient or non included centers), can be included in this national study, in a prospective way.

NCT ID: NCT03383458 Active, not recruiting - Clinical trials for Hepatocellular Carcinoma

A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation

CheckMate 9DX
Start date: April 18, 2018
Phase: Phase 3
Study type: Interventional

This study will investigate if nivolumab will improve recurrence-free survival (RFS) compared to placebo in participants with HCC who have undergone complete resection or have achieved a complete response after local ablation, and who are at high risk of recurrence

NCT ID: NCT03143270 Active, not recruiting - Liver Cancer Clinical Trials

A Study to Test the Safety and Feasibility of Nivolumab With Drug Eluting Bead Transarterial Chemoembolization in Patients With Liver Cancer

Start date: April 28, 2017
Phase: Early Phase 1
Study type: Interventional

The purpose of the study is to find out the effects of using nivolumab with Drug Eluting Bead Transarterial Chemoembolization (deb-TACE) in the treatment of liver cancer.