Trial Information

Tenofovir Disoproxil Fumarate Improves Outcomes Following Palliative Transarterial Chemoembolization for Hepatitis B Virus Related Hepatocellular Carcinoma

This is randomized double-blind placebo-controlled trial that will be conducted in referral
teaching hospitals in Taiwan. This trial will recruit 320 patients fulfilling all of the
following criteria: patients more than 20 years old, HCCs diagnosed by AASLD image criteria
or pathology, medium-sized HCCs in BCLC intermediate stage and not more than 5 cm in maximum
diameter and not more than 5 tumors that TACE is indicated, chronic HBV carrier (HBsAg+)
with detectable HBV DNA in blood, ECOG performance status (PST) 0-2, Child-Pugh score ≦7,
serum bilirubin < 2 mg/dL and prothrombin time (PT) prolongation < 3 seconds, and
willingness to adhere to treatment and follow-up plans. Patients are ineligible if they have
any of the following exclusion criteria: any vascular invasion by tumors, extra-hepatic
metastasis, concurrent any other malignancy, concomitant immunosuppressive therapy, previous
any HCC treatment, previous or current any antiviral therapy for HBV, concomitant other
therapies for HCC except TACE, liver cirrhosis with severe gastroesophageal varices (EVF3 or
with red color sign), poorly-controlled ascites or hepatic encephalopathy, contraindication
for invasive procedures such as recent gastrointestinal bleeding or cerebral hemorrhage,
contraindication to TACE such as allergy to contrast, pregnancy, sepsis, etc., chronic renal
failure with eGFR < 60, concurrent any other chronic viral hepatitis with HCV, HDV, or HIV).
The Primary endpoints of this study will be 1-, 3-year overall survival, and the secondary
endpoints of this study will be time to tumor progression and time to liver decompensation.