View clinical trials related to Hepatocellular Carcinoma.
Filter by:BACKGROUND: Hepatocellular carcinoma is the fifth most frequent cancer in the world, with a diagnosis of more than 500,000 new cases per year. It is considered the third leading cause of cancer mortality and presents well-defined risk factors. Liver cirrhosis is the main risk factor for developing HCC, therefore screening programs in cirrhotic patients will allow the early diagnosis of this neoplasia. Despite this, most HCCs are diagnosed at a stage in which the application of curative therapies is no longer possible. Hepatic transarterial chemoembolization (TACE) belongs to the arterially directed embolization therapies for the treatment of unresectable early-to-advanced hepatocellular carcinoma (HCC). It is the only therapy that has shown to improve survival in intermediate-stage HCC. Drug-eluting beads (DEB)-TACE has shown to provide slow drug elution, reduced liver and systemic toxicity, increased local drug concentration, and tissue necrosis. Aside from TACE, other transarterial options include bland embolization, or hepatic artery embolization (HAE), and transarterial radioembolization (TARE). All have an acceptable safety profile, and each has its associated procedural and peri-procedural complications. One potential complication that may occur during all embolization procedures is when the embolic material migrates outside of the desired treatment area, leading to non-target embolization (NTE). In fact, when collateral vessels are embolized, there is a risk that these may be feeders of non-target tissue or organs. NTE following TACE in particular may lead to a double-layer problem: dangerous components affecting healthy tissue, one ischemic and one related to cytotoxicity from the chemotherapeutic agent, which may have clinical consequences, and potential incomplete treatment of the lesion (due to beads being "deviated" from target). NTE is highly recognized, but often thought to be uncommon, and although different complications can be caused by it, there may appear to be no evidence of NTE during the intraprocedural imaging. To avoid the complications due to NTE, apart from the importance of the pre-, intra- and post-procedural imaging, and the thorough study of the anatomical picture, the catheters/microcatheters should also be chosen with reason and care. In particular, selective catheterization should be achieved by placing the microcatheter tip as close as possible to the target, through the specific branch/branches supplying it. However, even with the microcatheter selectively positioned in the vessel to be embolized, the risk of NTE might not be eliminated, since it could happen as a result of changes in flow dynamics that occur during embolization, particularly when the endpoint is stasis. These changes could result in reflux into non-target territories and, as such, might be better prevented with the use of microcatheters intended to reduce reflux. To this purpose, the use of a dedicated delivery device should be taken into consideration, in order to optimize and save time during the procedure. Microcatheters are commonly used during most arterial embolization procedures, and as explained above, there is a strong rationale to use a reflux-control microcatheter - like Sequre - for DEB-TACE. The main expectation is to achieve technical success with Sequre in all patients with a reachable target lesion, with the intent not only to minimize potential damage to surrounding tissue, but also to potentially deliver more treatment embolics, as all the beads are (re)directed towards the target. The use of small diameter particles (100 micron-TANDEM ® spheres), induces superior tumor necrosis response (Urbano et al., European Journal of Radiology, 2020); with the synergistic effect of being administered through the SEQURE anti-reflux protection system, there is reason to believe that it will be possible to administer maximum doses of doxorubicin, while avoiding the occlusion of non-target arterial segments (SYNERGIC EFFECT). STUDY PROPOSAL: We propose a prospective observational study with data collection from a single center (Virgen de las Nieves University Hospital-Granada), for a period that ranges October 2020-December 2021. Here summarized the inclusion criteria and contraindications: Inclusion criteria - BCLC B and or some case BCLC A - Both genders - Over 18 years. - Bilirubin less than 3 gr/dl. - No contraindications to the use of iodinated contrast - Absence of chronic kidney disease - ECOG 0-1. - Absence of encephalopathy. - Informed consent. Contraindications - Advanced liver disease. - Thrombosis or reversal of portal flow. - Vascular invasion. - Extrahepatic spread. - Contraindication to administration of cytostatics. - Contraindication to angiographic procedure.
A multicentric, open-label, single-arm prospective study to assess the efficacy and safety of tislelizumab combined with TACE as first-line treatment in patients with unresectable BCLC stage C HCC.
This is a Phase 2, single arm, single center study designed to evaluate the safety and tolerability of radiofrequency or microwave ablation combined with PD-1 monoclonal antibody in patients with hepatocellular carcinoma(HCC), with the secondary study objective to preliminarily evaluate the efficacy of radiofrequency or microwave ablation combined with PD-1 monoclonal antibody in patients with HCC and the exploratory study objective to evaluate the effect of ablation combined with PD-1 monoclonal antibody on immune function and hepatitis virus infection status in patients with HCC. This study will be divided into two stages, and the first stage is to enroll 6 patients for dose-limited toxicity (DLT) observation. If DLT appeared in < 2 patients, the second stage was entered and the other 24 patients were further enrolled.
Combination treatment with antiangiogenic agents and anti-programmed cell death protein 1 (PD-1) antibodies have shown high anti-tumor efficacy for patients with unresectable or advanced hepatocellular carcinoma (uHCC). In this single-center cohort study, we are aiming to (1) evaluate the clinical effectiveness in real-world patients, especially for Chinese patients, most of whom were with hepatitis B virus infection; (2) predict clinical effectiveness with clinicopathological features; (3) predict clinical effectiveness with histologic features and blood samples.
"Risk factors of Immune-ChEckpoint inhibitor MEdiated Liver, gastrointestinal, endocrine and skin Toxicity" (ICEMELT) study is a prospective multicenter cohort study, enrolling patients who are scheduled to receive (1) single agent PD1/L1 inhibitor; (2) PD1/L1 inhibitor plus CTLA4 inhibitor; (3) platinum-based chemotherapy + PD1/L1 inhibitor; (4) PD1/L1 inhibitor and tyrosine kinase inhibitor and (5) PD1/L1 inhibitor and vascular endothelial growth factor (VEGF) inhibitor.
This study aims to determine whether a breath test could be used for early detection of hepatic fibrosis, cirrhosis or hepatocellular carcinoma. Patients who are attending for a planned liver outpatient services or investigations will be approached to provide a breath sample. Multi platform mass spectrometry analysis will be performed to establish volatile biomarkers that can discriminate between fibrosis, cirrhosis and hepatocellular carcinoma.
This is a Phase I, open-label, multicenter study to characterize safety and tolerability, evaluate biodistribution, biological effects and immunogenicity, and evaluate the preliminary clinical efficacy of SynOV1.1 in participants with AFP positive solid tumors.
More than 80% of patients with cancer will be exposed to anaesthesia at some point in their treatment. There is increasing evidence that perioperative events, including the type of anaesthesia drugs utilised, have an impact on cancer recurrence and metastases. Although potentially and theoretically curative, surgical resection, manipulation and trauma may disseminate tumour cells and reduce immunity. There have been a number of suggestions as to why cancer may be, paradoxically, worsened by surgery and what methods may be used to mitigate this. One of these is propofol based total intravenous anaesthesia (TIVA), whereby the traditional inhalational anaesthetic drugs are avoided. Commonly used inhalational drugs, such as sevoflurane and desflurane, are pro-inflammatory. Propofol, however, has anti-inflammatory and anti-oxidative properties, induces apoptosis and has specific inhibitory effects on tumour cell growth in vitro. Laboratory investigations, animal models, retrospective clinical studies and initial clinical research are producing evidence that inhalational anaesthesia facilitates tumour recurrence and metastasis, whilst TIVA can prolong survival. This randomised, controlled trial will look at the effects on DNA damage and biomarkers of immunity and inflammation of inhalational anaesthesia versus TIVA in patients undergoing surgery for hepatocellular carcinoma, a common tumour in the Southern Chinese population, for whom surgery is potentially-curative. It will focus on subjects undergoing open and laparoscopic hepatectomy and investigate changes in biomarkers of inflammation, immunity and gene expression from the patients' blood samples taken before, during and after surgery. Patients will also be followed-up for cancer recurrence, morbidity and five-year mortality. Results could represent a breakthrough in knowledge of how anaesthetic agents impact the results of cancer surgery, and have important implications for a more disease- sensitive approach to improving management and outcomes in these patients.
Hepatocellular carcinoma (HCC) is the second commonest cause of cancer death worldwide. Liver transplantation (LT) is the best curative treatment of HCC meeting Milan/UCSF criteria. 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. Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for advanced HCC. Neo-adjuvant TAI for the HCC patients with beyond criteria serving as a down-staging method for the advanced HCC to meet Milan/UCSF criteria，and qualify for LT. This study is to compare the impact on survival of neo-adjuvant TAI for patients with beyond Milan/UCSF Criteria HCC who underwent LT.
Hepatocellular carcinoma (HCC) is the fifth more common cancer in the world, with high mortality rates, due to the low number of patients who are eligible for therapy with curative intent, like surgical resection. Moreover, surgical resection is associated with a high risk of tumor recurrence, because of the tumor seeding through microscopic intrahepatic vessels that surround the tumor, the so-called "microvascular invasion". To adequately deal with this phenomenon, the surgeon has to perform either an 'anatomical' liver resection, which remove not only the tumor but also the whole corresponding vascular network, or a 'tumorectomy' with resection margins of at least 2 cm. Unfortunately, these principles cannot always be achieved due to underlying liver cirrhosis that is present in more than 80% of patients. Stereotactic body radiation therapy (SBRT) has been proven to efficiently necrotize or stabilize HCC nodules when surgery is not possible. Our hypothesis is that pre-treatment with SBRT prior to surgical resection of HCC might improve the results through the destruction of possible seeding in the peritumoral environment. Given the novelty of this therapeutic strategy, it is necessary to verify its feasibility and safety, prior to test its efficacy in patients with HCC. The KARCHeR-1 study aims at making sure that preoperative SBRT would not result in important delays or serious adverse events such as to cancel the planned surgical resection, in patients who otherwise could have benefited from it. This issue is commonly called 'drop-out'. Thirty patients are expected to be included in the KARCHeR-1 study, which would be in favor of continuing to evaluate this therapeutic strategy if less than 3 drop-outs occur, and would be immediately discontinued if 3 drop-outs occur. Other outcomes will also been studied, like intraoperative issues, postoperative morbi-mortality, pathological features on the surgical specimen and its correlation with preoperative imaging, and finally, tumor recurrence and survival.