Doxorubicin Transdrug® in Advanced Hepatocellular Carcinoma.

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2008
INTERVENTION: Hepatic Intrarterial‐Injection of Doxorubicin Transdrug® at 30mg/m2. 3 courses, one course every 28 days. CONDITION: HepatoCellular Carcinoma PRIMARY OUTCOME: Number of patients free of local progression at 3 months after randomisation (control group). Number of patients free of local progression at 3 months after randomisation (treatment group). SECONDARY OUTCOME: Comparison between the treated and control groups: progression free survival, overall survival, objective response rate, tolerance and quality of life To determine the pharmacokinetic profile of Doxorubicin Transdrug. INCLUSION CRITERIA: Patients with hepatocellular carcinoma (HCC); Multinodular hepatocellular carcinoma more than one lesion) regardless of the number of lesions, but involves less than 50% of the liver mass; Child‐Pugh score A (assessment of the prognosis of chronic liver disease, mainly cirrhosis); Left ventricular ejection fraction (LVEF) greater than or equal to 50% as determined by echocardiography/cardiac ultrasound (the amount of blood pumped out of a ventricle with each heart beat); Adequate pulmonary function; Platelets greater than or equal to 75 x 109L; Absolute neutrophil count (white blood cells)greater than or equal to 1,0 x 109L; Aspartate transaminase (AST) and/or Alanine transaminase (ALT) less than or equal to 5 times upper limit of normal (liver enzymes, determine the health of the liver); Prothrombin time ratio greater than 60% and Factor V greater than 60% (measure of blood clotting ability).
Epistemonikos ID: 8d9bbb45e55cbc850ec52d92ffe1d05934a24c73
First added on: Aug 21, 2024