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Liver Transplantation clinical trials

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NCT ID: NCT04443322 Recruiting - Clinical trials for Liver Transplant; Complications

Durvalumab and Lenvatinib in Participants With Locally Advanced and Metastatic Hepatocellular Carcinoma ( Dulect2020-1 )

Dulect2020-1
Start date: September 19, 2020
Phase: N/A
Study type: Interventional

This study will evaluate the safety and efficacy of durvalumab in combination with lenvatinib in participants with locally advanced hepatocellular carcinoma before liver transplant and metastatic unresectable HCC.The primary hypothesis of this study are that patients with locally advanced HCC could benefit from durvalumab plus lenvatinib before liver transplant; patients with metastatic unresectable HCC could also benefit from durvalumab plus lenvatinib with respect to: 1)Progression Free Survival (PFS) ; or recurrence-free survival (RFS) if patients with locally advanced HCC underwent liver transplant; 2) Objective Response Rate (ORR); and 3) Overall survival (OS). The investigators design a clinical study to explore whether the combination above as a treatment in patients with advanced and recurrent endometrial carcinoma could prolong PFS and to analyze potential immune biomarker of therapeutic response.

NCT ID: NCT04425226 Recruiting - Clinical trials for Liver Transplant; Complications

Pembrolizumab and LENvatinib in Participants With Hepatocellular Carcinoma (HCC) Before Liver Transplant

PLENTY202001
Start date: August 6, 2020
Phase: N/A
Study type: Interventional

Objectives of Study:This study will evaluate the safety and efficacy of pembrolizumab in combination with lenvatinib as neoadjuvant therapy in participants with hepatocellular carcinoma (HCC) exceeding Milan criteria before liver transplant. The primary hypothesis of this study are that neoadjuvant pembrolizumab plus lenvatinib is superior to regularly waiting in the list with respect to: 1) recurrence-free survival (RFS) as assessed by blinded independent central review (BICR); and 2) Objective Response Rate (ORR).The investigators design a clinical study to explore whether the combination above as a neoadjuvant treatment in patients with advanced HCC before liver transplant could reduce postoperative recurrence and to analyze potential immune biomarker of therapeutic response.

NCT ID: NCT04413695 Recruiting - Clinical trials for Liver Transplant; Complications

Lung Ultrasound as a Point of Care Test for Living Donor Liver Transplant Recipients.

Start date: November 11, 2019
Phase:
Study type: Observational

Liver transplant is now a standard treatment for end-stage liver disease patients. Pulmonary complications are common in the perioperative period and are associated with adverse outcomes. This includes atelectasis, pneumothorax, pleural effusion, pulmonary edema, and collapse. Risk factors for the same are extensive surgery, transfusion of blood products, fluid overload, hemodynamic instability, coagulation abnormalities, renal dysfunction, and reperfusion syndrome. CXR with clinical judgment plays a key role in diagnosing pulmonary complications. However diagnostic ability of CXR is limited and moreover it is associated with unnecessary radiation exposure. Recently, lung USG has come up as an easily available tool to detect peri-op pulmonary complications. The technique is very easy to perform, less time-consuming, and totally cost-effective. Moreover, it can be easily learned by clinicians with a standard level of ability to handle an ultrasound probe for abdominal scans. In the setting of geriatric and ICU patients, fragility and immobility have a strong impact on the quality of a chest radiograph. So, the routine application of lung USG in this setting may significantly improve the outcome. Multiple studies have suggested that Lung USG is superior to CXR in diagnosing these lung conditions. Hence, this study aims to compare the lung ultrasound with CXR in detecting perioperative pulmonary complications in patients undergoing live donor liver transplantation.

NCT ID: NCT04410471 Recruiting - Covid19 Clinical Trials

Humoral Immunity Against SARS-CoV-2 in Liver Transplanted Patients After COVID-19 in Comparison With Immunocompetent Patients

Start date: May 29, 2020
Phase:
Study type: Observational [Patient Registry]

This is a prospective study analyzing the development of humoral immune response against SARS-Cov-2 in patients with previous Covid19: the aim is to compare the incidence, titration and evolution of IgG an IgM in a prospective cohort of liver transplant patients surviving to the first wave of Covid19, in comparison to not inmmunossupressed patients.

NCT ID: NCT04327427 Recruiting - Clinical trials for Liver Transplant; Complications

Outcome Analysis of Aspirin in Liver Transplantation

Start date: October 1, 2019
Phase:
Study type: Observational

In the experimental setting inhibition of platelet activation was able to reduce immune-mediated necroinflammatory liver disease and consecutively hepatocellular carcinoma development. Therefore, antiplatelet therapy may not only have a preventive effect on hepatic artery patency but also on tumor recurrence. So far and to the best of our knowledge, no study investigated the effect of antiplatelet therapy on hepatic arterial patency, tumor recurrence and graft survival after primary liver transplantation.

NCT ID: NCT04232904 Recruiting - Clinical trials for Inflammatory Response

Effect of Transversus Abdominis Plane Block on Anti-inflammatory Response

Start date: December 2, 2019
Phase: Phase 4
Study type: Interventional

The liver transplantation is the only treatment for end-stage liver failure. Lack of sufficient organs from the cadaver to meet the organ needs has increased the interest in a live organ donor transplantation. A peripheral nerve block, transversus abdominous plane block (TAP block); When combined with general anesthesia in live liver donors, it has been shown to significantly reduce perioperative and postoperative opioid consumption, provide shorter recovery time and shorten hospital stay. It has been shown that regional block techniques using local anesthetics and analgesic adjuvants modulate both local and systemic inflammatory reactions caused by surgical injury. Cytokines are important mediators of local and systemic inflammatory response including hyperalgesia after surgery. In literature, the effect of TAP block on anti-inflammatory cytokines in live liver donors was not shown. The aim of this study is to investigate the effect of bupivacaine TAP block on antiflammatory response in living liver donors.

NCT ID: NCT04204850 Recruiting - Clinical trials for Hepatocellular Carcinoma

Cabozantinib to Treat Recurrent Liver Cancer Post Transplant

Start date: August 7, 2020
Phase: Phase 2
Study type: Interventional

This is a phase 2 study that will assess the investigational drug, cabozantinib, in patients with liver cancer (specifically hepatocellular carcinoma) and who had received a liver transplant as a part of curative care, but the cancer has come back (recurred). The purpose of this study is to see how useful cabozantinib is in controlling the disease of these patients. Cabozantinib blocks the function of various proteins found on the surface of the body's cells (called receptor tyrosine kinases) that are important in the development of cancer tumors. All participants will receive cabozantinib until they are no longer receiving benefit from the study drug or they experience an intolerable side effect.

NCT ID: NCT04203004 Recruiting - Clinical trials for Liver Transplantation

HOPE With Cytokine Filtration in Liver Transplantation (Cyto-HOPE)

Cyto-HOPE
Start date: September 23, 2021
Phase: N/A
Study type: Interventional

Ischemia-reperfusion injury (IRI) is unavoidably typical of solid organ transplantation. Post-reperfusion syndrome (PRS), characterized by hemodynamic instability at reperfusion of the implanted graft, is a possible complication of liver transplantation. For sure, IRI plays a fundamental role in the multifactorial pathogenesis of PRS. IRI and PRS are associated with a higher risk of early allograft dysfunction (EAD) and, consequently, graft failure. Liver grafts from both extended criteria donors (ECD) and donation after circulatory death (DCD) are particularly susceptible to IRI and, accordingly, are at higher risk of PRS, EAD and graft failure. Anyway, in the present scenario of organ shortage, such donors greatly contribute to enlarge the organ pool. So, various strategies have been developed for the purpose of a safer use of this kind of grafts. Among them, ex vivo hypothermic oxygenated perfusion (HOPE) reduces IRI and is beneficial for high-risk liver grafts. The pathogenesis of IRI is an extremely complex downstream inflammation process, involving many different cytokines, chemokines and growth factors. In particular, tumor necrosis factor-alfa (TNF-alfa), interleukin-6 (IL-6), IL-8 and endothelin-1 (ET-1) are crucial in the development of IRI in liver transplantation. In experimental models, cytokine filtration during ex vivo lung perfusion (EVLP) was proved to be safe and effective in reducing inflammatory response and, thus, pulmonary edema development. Since - in liver transplantation, IRI and PRS are associated with a higher risk of EAD and graft failure - liver grafts from ECD and DCD are particularly susceptible to IRI and are at higher risk of PRS, EAD and graft failure - HOPE of high-risk liver grafts reduces IRI - in solid organ transplantation, various cytokines, chemokines and growth factors are involved in the pathogenesis of IRI - in experimental models of EVLP, cytokine filtration was proved to reduce inflammatory response and subsequent organ damage, our hypothesis is that cytokine filtration during HOPE of high-risk liver grafts may potentiate the beneficial effects of HOPE, further reducing IRI and, consequently, further decreasing the incidence of PRS and EAD. So, the aim of this study is to verify the feasibility and safety of cytokine filtration during end-ischemic HOPE of liver grafts.

NCT ID: NCT04199819 Recruiting - Clinical trials for Liver Transplant; Complications

Detecting Occult HBV Infection in Liver Donors Positive for Antibody to Hepatitis B Core Antigen (Anti-HBc)

OBI
Start date: January 1, 2022
Phase: N/A
Study type: Interventional

After LT, long-term immunosuppressive therapy is required to prevent organ rejection. Therefore, for organs which may harbour OBI, there is a risk of reactivation which may result in liver graft failure. As a consequence, all patients who receive an anti-HBc positive graft will receive antiviral prophylaxis. Currently, all such patients will be commenced on life-long entecavir, which is highly effective in preventing reactivation.2 One major disadvantage of using such a blanket approach is that a significant proportion of anti-HBc donors may not actually have underlying occult HBV infection, and recipients of such grafts may not require lifelong antiviral therapy. Current markers such as HBsAg and HBV DNA are not sensitive enough to detect the presence of OBI. This is the first trial proposed to look at the efficacy of these novel HBV biomarkers in identifying occult HBV infection when used in combination, and to identify patients who will not need long term antiviral prophylaxis.

NCT ID: NCT04186234 Recruiting - Liver Cancer Clinical Trials

SBRT for Liver Cancer Before Liver Transplantation

Start date: January 1, 2015
Phase: N/A
Study type: Interventional

Hepatocellular carcinoma (HCC) is the second commonest cause of cancer death worldwide. It is the third leading cause of cancer death in Hong Kong. Liver transplantation (LT) is the curative treatment of choice for HCC as it has the advantage of removing the tumour and also the premalignant cirrhotic liver. Milan (solitary tumour <5cm, or up to 3 tumours, each <3cm) and University of California San Francisco (UCSF) criteria (solitary tumour ≤6.5cm, up to 3 tumours with none >4.5cm, and total tumour diameter ≤8cm) provide the benchmark requirements for LT, at which a 5-year survival of >70% and recurrence rate ranging from 5-15% can be achieved. However, organ shortage and waiting time for liver grafts remain the greatest obstacles for deceased donor liver transplantation (DDLT). It has been reported that the waiting list dropout rate is 7 to 11% at 6 months and 38% at 12 months. Several therapeutic procedures including transarterial chemoembolisation (TACE) and stereotactic body radiation therapy (SBRT) have been studied as bridging therapy before DDLT, aiming at reducing waiting list dropout rate and recurrence after LT, and improving post-transplant survival. The investigators have carried out a prospective study on HCC patients treated with bridging SBRT before LT. The investigators used dual tracer (18F-fluorodeoxyglucose [FDG] and 11carbon-acetate [ACC]) positron-emission tomography with integrated computed tomography (PET-CT) and magnetic resonance imaging with gadoxetate disodium as baseline and subsequent imaging assessment before and after SBRT, hoping the PET-CT can help better identify those who benefit from SBRT and to prioritise those with poor response so that they can be better channeled to LT.