Objectives. Assessment of gemcitabine/carboplatin combination in patients with advanced-stage hepatocellular carcinoma (HCC) in a phase II trial for safety and efficacy. Methods. Forty patients with previously untreated advanced-stage HCC were prospectively enrolled and subjected to gemcitabine/carboplatin regimen which consisted of gemcitabine 1000？mg/m2 on days 1 and 8, and carboplatin AUC 6 on day 1. The treatment was repeated every 3 weeks until disease progression or limiting toxicity. Results. Forty patients were assessable for efficacy and toxicity. In all, 276 treatment cycles were administered. No toxic deaths occurred. Hematological grade 3-4 toxicity consisted of thrombocytopenia (27% of patients) and neutropenia (24%), including 2 febrile neutropenia and anemia (9%). Grade 3 carboplatin-induced neurotoxicity was observed in 3 (9%) patients. ORR was 23% (95% CI, 0.10–0.29) with 9 partial responses and disease stabilization was observed in 46% (95% CI, 0.22–0.42) of patients, giving a disease control rate of 69%. Median progression-free and overall survival times were, respectively, 5 months (95% CI: 3–8 months) and 8 months (95% CI: 6–18 months). Conclusion. The gemcitabine/carboplatin regimen seems to be effective, well tolerated, and active in advanced HCC. 1. Introduction Hepatocellular carcinoma is the fifth most common cancer in men and eighth in women worldwide, resulting in at least 500,000 deaths per year [1]. Over a decade, there was nearly a twofold increase of the proportion of HCC among CLD patients in Egypt with a significant decline of HBV and slight increase of HCV as risk factors. Alpha-fetoprotein played a limited role in diagnosis of HCC, compared to imaging techniques [2]. Diagnosis is usually made by history, physical examination, imaging (US, CT, MRI), and elevated serum AFP > 400？ng/mL with 75% of hepatocellular carcinoma is multifocal at time of diagnosis. In most patients with HCC, we are dealing with two independent diseases, each determines the patient outcome. Treatment plan should consider the disease extent, hepatic functional reserve, and patient’s performance status [3]. Liver resection is the first curative option with 3？yr survival of 54% in the noncirrhotic liver after R0 resection. Transplantation comes next in patients fulfilling Milan criteria, or the expanded UCSF criteria, with 3？yr survival of up to 88%. Ablative modalities such as TACE, RFA, and others are accepted alternatives either as palliation, or bridging before liver transplant. For HCC patients with extrahepatic extent or extensive disease not
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