View clinical trials related to Hepatocellular Carcinoma.
Filter by:An open-label, Phase I/II study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of AST-3424 administered as a single agent
The use of devices for liver grafts perfusion before transplantation, either hypothermic (HOPE) or normothermic (NMP), is rapidly spreading thanks to the promising results obtained so far in terms of graft survival and post-operative morbidity. Besides the well-established ability to increase the rate of transplantability of extended criteria donors (ECD) and donors after cardiac death (DCD), the use of machine perfusion (MP) may also improve the oncological outcomes of patients affected by hepatocellular carcinoma (HCC) undergoing liver transplantation (LT). The underlying mechanism is represented by the modulation of the ischemia-reperfusion injury (IRI)-related cellular damage obtained by the liver graft perfusion with HOPE before LT. The identification of biomarkers able to predict graft outcomes and highlight the mechanism of graft injury before transplantation rapidly and in non-invasive manner is therefore needed. Mass spectrometry-based metabolomics has already shown its potential by using perfusion liquids or pre-implantation biopsies. The aim of the investigators is to run an open-label, randomised, controlled trial to study the impact of treating standard liver grafts from brain dead donors (DBD) with HOPE before liver transplant in patients affected by HCC. Patients aged 18-75 years presenting with HCC Milan-in at listing will be considered for inclusion. Presence of extra-hepatic disease and general contraindications to liver transplantation as defined by the local tumor board are considered as exclusion criteria. Eligible patients will be randomly assigned (1:1) with the use of a dedicated software to MP (intervention group) or no-MP (control group) before liver transplantation. Untargeted mass spectrometry metabolomics (UHPLC-HRMS) will be performed on liver graft perfusate, liver graft biopsy and recipient blood samples, to identify by classification methods, novel predictive markers of IRI. Furthermore, rapid targeted MS approaches will be performed on VIP metabolites and known key compounds (such as TCA, aminoacids, energy metabolism) to rapidly assess graft function as well as post-operative outcome. Blood samples of the recipient will be collected at two checkpoints (listing, and 3 months after liver transplant) to evaluate exosomes and miRNA expression fluctuations (liquid biopsy). Primary outcomes of the study will be overall survival, graft survival and recurrence-free survival at 1- and 2-years. Survival results will be compared to those expected based on the Metroticket 2.0 score to assess the impact of MP in reducing the risk of HCC recurrence. Patients will remain in follow-up as for clinical practice to assess 3- and 5-years survival. Secondary end-point will be to define liquid biopsy efficacy to predict HCC recurrence and to define the correlation between metabolomic observations and HCC recurrence pattern.
This is a single-center, single-arm, open-label study that includes patients meeting the inclusion criteria (liver-GTV volume < 700ml or estimated liver-GTV V5 < 300ml) with hepatocellular carcinoma with diffuse tumor thrombosis involving both left and right lobes. All lesions receive moderate-dose hypofractionated intensity-modulated radiotherapy, with a gross tumor dose of 25Gy/5f, and a maximum dose of 35Gy/5f at the tumor center. One week before or during the radiotherapy, patients receive concurrent Tislelizumab at a dose of 200mg. Subsequently, Tislelizumab is administered intravenously every 3 weeks. Follow-up examinations are conducted 1-3 months post-radiotherapy. Lenvatinib 4mg may be used for maintenance therapy with Tislelizumab if there are no contraindications. Maintenance therapy is continued until disease progression or intolerance. The primary endpoint is median overall survival (mOS), and secondary endpoints include objective response rate (ORR), progression-free survival (PFS), and toxicity.
National, multicenter, retrospective, non-randomized observational study (Real World Evidence-RWE) with the purpose of analyzing the epidemiological profile of Hepatocellular Carcinomas (BCLC A, B or C), clinical management, progression profile and overall survival of castrated patients treated in national oncology care reference centers, within the last 6 years (between 2017 to 2022).
The trial is designed as a single-arm, open-label, phase I study investigating an off-the-shelf, multi-peptide-base HCC vaccine plus Montanide, combined with Durvalumab in patients with very early, early and intermediate stage of HCC. The investigational agents will be applied without concomitant anti-tumour therapy with the intention to reduce risk of recurrence/progression in patients who have received all indicated standard treatments.
The aim of this trial is to carry out the first prospective multicentric study which evaluates the efficacy and the safety of SBRT in HCC patients enlisted for LT and not suitable for other bridging interventional treatments (RF or TACE). The incidence of hepatocellular carcinoma (HCC) is increasing worldwide and is currently the first indication for Liver transplantation (LT). HCC patients access to LT is not only determined by the underlying liver function but also by the alpha-fetoprotein (aFP) score which allows to better identify patients with high risk of recurrence. LT is the best curative treatment as it can cure both the tumor and the underlying liver disease. However, the access to LT is limited due to organ shortage and preserved liver function for the majority of the patients with HCC. Bridging therapies, such as ablation by radiofrequency (RF) or microwaves, or trans-arterial chemoembolization (TACE), are carried out routinely to prevent the risk of tumor progression and drop-out during the waiting time (the drop-out rate being 20%). Nevertheless, only 50 to 70% of patients in France will have access to these treatments due to specific contraindications. Stereotactic body radiotherapy (SBRT) has emerged as a non-invasive alternative and potentially efficient treatment of single or bilocular HCC. SBRT is a high-precision technique allowing to deliver a precise high dose irradiation on moving intrahepatic lesions. RTS is feasible only when the hepatic reserve is sufficient to avoid radic hepatitis. Advantages of SBRT, as compared to TACE or RF, are 1) to preserve the hepatic artery, which can be altered by TACE 2) to allow access to complex tumors locations or superficial lesions not feasible by RF 3) to avoid any tumor spread related to punctures 4) to avoid general anesthesia. However, SBRT has not been validated as bridging therapy before LT in a prospective study. Thus, this study is the first prospective multicentric study to evaluate this treatment modality in HCC patients enlisted for LT not suitable to RF or TACE.
The goal of this first in human clinical trial is to test BI-1910 administered as single agent and in combination with pembrolizumab in subjects with advanced/metastatic solid tumors whose disease has progressed after standard therapy. The main questions it aims to answer are: - how safe and tolerable is BI-1910 - what is maximum tolerated or administrated dose - to determine recommended dose for further clinical trials Participants will receive infusions of BI-1910 alone or combination with pembrolizumab every 3 weeks.
This is a single-arm prospective phase II clinical trial to investigate the efficacy and safety of adjuvant simultaneouslyintegrated boost radiotherapy following narrow-margin(<1cm) hepatectomy in patients with HCC. Eligibility patients will receive IMRT or VMAT to high risk area of tumor bed and tumor bed. The prescription dose to 95% GTVtb boost was planned at 55-60Gy, with PTV 45-50Gy, in 23-25 fractions, mainly depending on the dose constraints of OARs. The primary endpoint is the 3-year OS, the secondary endpoints are disease-free survival, patterns of failure, toxic events and local control rate.
In this study, the investigators will detect hepatocellular carcinoma lesions using fluoescence imaging with ITGA6 targeting probes during tumor resection surgery. The aim is to evaluate wether intraoperative fluorescence imaging targeting ITGA6 can help to improve the detction effect of hepatocellular carcinoma, and finally help the accurate surgical resection. The main purposes of this study include: 1. To raise the detection rate of hepatocellular carcinoma intraoperatively using the novel NIR-II fluorescence molecular imaging and the ITGA6 targeting probe. 2. To validate the safety and effectiveness of the proposed ITGA6 targeting probes for clinical application.
The goal of this clinical trial is to compare CT scan of the coverage of tumors treated with TACE using End Hole catheters to those treated with the TriNav catheter that alters tissue pressure. Both catheters are FDA approved for delivery of TACE. • Is there a difference in CT appearance with delivery in the type of catheter used during the TACE procedure? Participants will be asked to undergo a TACE procedure, a CT scan and review of their medical record to compare End Hole and TriNav catheters during TACE procedures.