A randomized phase II study of doxorubicin combined with thalidomide versus doxorubicin alone for patients with unresectable hepatocellular carcinoma

INTERVENTION: Control arm: doxorubicin 60 mg/m2 day 1, three weekly course with in total 6 cycles (maximum 360 mg/m2) given intravenously in 15 minutes. Experimental arm: doxorubicin treatment as in control arm plus from day 3 on, thalidomide 200 mg daily administerd in the evening. When doxorubicin administration has finished, thalidomide should be continued until progression of disease. CONDITION: ; Hepatocellular carcinoma ; ; PRIMARY OUTCOME: The 1‐year survival. SECONDARY OUTCOME: Response rate scored according to RECIST criteria, time to progression, quality of life, and toxicity. INCLUSION CRITERIA: Histologically proven HCC, irresectable tumor, failure to previous treatment, WHO 0‐2, at least 4 weeks since prior treatment with HMG‐Coa reductase inhibitors or systemic immunosuppresiva, adequate hepatic and bone marrow function.