Carcinoma hepatocelular. Na Europa, foram diagnosticados O CHC raramente ocorre antes dos 40 anos e atinge pico aproximadamente aos 70 anos. Vias moleculares do hepatocarcinoma. Estadiamento e tratamento. Conflitos de interesse.
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Print Download. Examples: Cancer AND drug name. Pneumonia AND sponsor name. How to search [pdf]. For these items you should use the filters and not add them to your search terms in the text field. Print Download Summary. Review by the Competent Authority or Ethics Committee in the country concerned. As of 1. EU Clinical Trials Register.
Search tools. Select Date Range: to. Select Rare Disease:. IMP with orphan designation in the indication. Orphan Designation Number:. Results Status: Trials with results Trials without results. Clear advanced search filters. Date on which this record was first entered in the EudraCT database:. A multicenter, open-label, single-arm study of the safety and antitumoral efficacy of nivolumab in combination with selective internal radiation therapy SIRT using SIR-Spheres for the treatment of patients with hepatocellular carcinoma that are candidates for locoregional therapies.
Title of the trial for lay people, in easily understood, i. Nivolumab after selective internal radiation therapy using SIR-Spheres to treat patients with primary liver cancer: a safety and efficacy study.
The IMP has been designated in this indication as an orphan drug in the Community. Committee on Advanced therapies CAT has issued a classification for this product. Combination product that includes a device, but does not involve an Advanced Therapy.
Age years-old or above Diagnosis of HCC based on histology or non-invasive criteria if cirrhotics. Patients with fibrolamellar carcinoma are not excluded. Chronic liver disease absent, non-viral or due to hepatitis C or B virus infection. Subjects with chronic HBV infection must be on effective antiviral therapy Preserved liver function without cirrhosis or with compensated cirrhosis in Child Pugh Class A.
Unsuitability for TACE in patients with single tumors of size between 5 and 10 cm will follow local practice in the treating center. In summary, they should fall within the up-to-7 rule the sum of the number of tumors and the maximal size of the largest lesion in cm should be higher than 7 and should be in a Child-Pugh stage A.
Los pacientes con hepatocarcinoma fibrolamelar no quedan excluidos. Any history of hepatic encephalopathy Any prior within 1 year or current clinically significant ascites. Any history of clinically meaningful variceal bleeding within the last three months. Active coinfection with both hepatitis B and C or hepatitis D infection in subjects with hepatitis B Occlusive main trunk portal vein thrombosis or absence of intrahepatic portal blood flow if patient carries a portocaval shunt.
Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.
Any active autoimmune disease. Any severe organ disease Prior therapy with any drug specifically targeting T-cell costimulation or checkpoint pathways. Prior organ allograft or allogeneic bone marrow transplantation Recent active bacterial or fungal infections.
Any condition requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days of study drug administration. Cualquier enfermedad autoinmune activa. The primary endpoint is the rate and type of adverse events AEs , serious AEs, liver decompensation, and transient and permanent drug discontinuations due to toxicity. Up to days after the last dose of nivolumab.
The secondary endpoints are the rate of objective response, disease control, duration of response and time to progression based on RECIST criteria v 1. For the entire duration of the study. The trial involves single site in the Member State concerned. Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial.
Plans for treatment or care after the subject has ended the participation in the trial if it is different from the expected normal treatment of that condition.
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We'd like to understand how you use our websites in order to improve them. Register your interest. Surgical therapy offers the only chance for long-term cure of patients with hepatocellular carcinoma. The role of partial and total hepatectomy with subsequent liver replacement was analyzed in a consecutive series of patients. It was the aim of this study to compare both treatment modalities on the basis of various clinicopathological prognostic factors including the TNM system of pathological classification. One hundred thirty-one resections and 61 transplantations were performed for the following histological diagnoses: hepatocellular carcinoma without coexisting liver disease 86 or associated with various hepatic abnormalities 79 , fibrolamellar carcinoma 19 , and mixed hepatocholangiocellular carcinoma 8. Overall actuarial survival rates at 5 years were