Supervisors info:
Μαλαγάρη Αικατερίνη, Καθηγήτρια, Ιατρική Σχολή, ΕΚΠΑ
Κελέκης Αλέξιος-Χρυσόστομος, Καθηγητής, Ιατρική Σχολή, ΕΚΠΑ
Κουλουλίας Βασίλειος, Καθηγητής, Ιατρική Σχολή, ΕΚΠΑ
Summary:
Liver cancer is the fifth most common cancer and the second most frequent cause of cancer-related death globally. Hepatocellular carcinoma represents about 90% of primary liver cancers and constitutes a major global health problem. (EASL, 2018)
Hepatocellular carcinoma has been recognised as a leading cause of death among patients with cirrhosis, and its incidence is expected to increase in the future. (Forner A. et al, 2018). Approximately 80% of cases of HCC develop in a cirrhotic liver. The incidence of HCC is higher in men than women. The average age of patients at HCC diagnosis is 66 years (Walton M, et al, 2019)
Transarterial chemoembolisation (TACE) is the most widely used primary treatment for unresectable HCC and was the recommended first-line therapy for patients with intermediate-stage disease (EASL, 2018)
Loco-regional interventional treatments continue to evolve and to play a major role in the therapeutic management of hepatocellular carcinoma (HCC). Transarterial chemoembolization (TACE) is the standard of care for patients with multinodular disease at the intermediate stage (BCLC stage B) who have well-preserved liver function and large or multinodular HCC without portal vein tumor thrombosis or extrahepatic metastasis. (Piscaglia F, Ogasawara S, 2018) The ideal TACE scheme should allow maximum and sustained concentration of chemotherapeutic drug within the tumor with minimal systemic exposure combined with tumoral vessel obstruction. (Lencioni R, et al, 2010)
TACE techniques include: conventional TACE (Lipiodol-TACE or c-TACE) and embolic microspheres loaded with chemotherapeutic agents (DEB TACE, Hepasphere TACE, Drug eluting microspheres Lifepearl, Lumi, DC Bead, TANDEM)
A common protocol structure and organization will facilitate protocol review by oversight entities. Its use will also help investigators think through the scientific basis of their assumptions, minimize uncertainty in the interpretation of outcomes, and prevent loss of data.
A clinical trial protocol should have Scientific Validity, Social Value, Favorable Risk-Benefit Ratio, Fair Subject Selection, Respect for Subjects, Informed Consent, Independent Review. It should be conducted in accordance with ICH-GCP, local, federal and international laws and regulations. An ethical research study must have scientific integrity, social value, and contribute to medical knowledge. In the protocol design of a clinical trial, it is useful to introduce a specific ethical section with a summary of the value of the study.
Keywords:
Protocol design, Regional interventional treatment, Cirrhosis, HCC, TACE
