This article reports a prospective randomized controlled study to investigate the effect of sex hormone therapy combined with intra-arterial chemotherapy for hepatocellular carcinoma (HCC). Thirty patients with unresectable HCC were randomly divided into two groups. A catheter was inserted into the hepatic artery of all patients. The first group (group A) was administered 60 mg/m2 of cisplatin (CDDP) on day 15 and 13 mg/m2 of Adriamycin (ADM) on day 1 and 8 postoperatively via the hepatic artery cannula; in addition, a daily dose of 150 mg 5-fluorouracil (5-FU) was administered orally. Tamoxifen (TAM) 25 mg/m2 daily and medroxyprogesterone acetate (MPA) 400 mg/m2 daily were also administered orally. TAM and MPA administration were alternated every 4 weeks. For the second group (group B) the same protocol of anti-cancer drugs administration, without the hormonal agents, was given. At least three courses of the treatments were carried out. Twelve patients in group A and 14 in group B were evaluated. Partial response of the hepatic tumor to the treatments was observed in 33.3% of group A patients and 21.4% of group B patients, a difference that was not statistically significant. The 1-year survival rate was 44.5% in group A and 33.0% in group B. The performance status of 25% of the patients in group A was significantly improved compared with 14.3% in group B (p < 0.05). TAM- and MPA-combined chemotherapy may not prolong the survival of patients with HCC, although it improves their quality of life.
