Chapter 088. Hepatocellular Carcinoma (Part 8) Table 88- 5 Some Randomized Clinical Trials Involving Transhepatic Artery Chemoembolization (TACE) for Hepatocellular Carcinoma Author Yea r Agents 1 Agents 2 Surviva l Effect Kawaii 1992 Doxorubici n + embo Embo No Chang 1994 Cisplatin + embo Embo No Hatanaka 1995 Cisplatin, doxorubicin + embo Same + ethiodol No Uchino 1993 Cisplatin, doxorubicin + oral FU Same + tamoxifen No Lin 1988 Embo Embo + IV FU No Yoshikaw a 1994 Epirubicin + ethiodol (Lipiodol) Epirubici n No Pelletier 1990 Doxorubici n + Gelfoam None No Trinchet 1995 Cisplatin + Gelfoam None No Bruix 1998 Coils and Gelfoam None No Pelletier 1998 Cisplatin + ethiodol None No Trinchet 1995 Cisplatin + Gelfoam None No Pelletier 1998 Cisplatin + ethiodol None No Lo 2002 Cisplatin + ethiodol None Yes Llovet 2002 Doxorubici n + ethiodol None Yes Note: embo, embolization; FU, fluorouracil. Experimental Therapies Several therapies are being evaluated (Table 88-6). Epidermal growth factor (EGF) receptor antibodies and EGF receptor kinase inhibitors are in clinical trials, as are various anti-angiogenesis therapies. No effects on survival are yet reported. Oral sorafenib increases median survival from 6 to 9 months in advanced, unresectable HCC. Several forms of radiation therapy have been used in the treatment of HCC, including external beam and conformal radiation therapy. Radiation hepatitis remains a significant dose-limiting problem. The pure beta emitter 90 yttrium attached to either glass or resin microspheres has been assessed in phase II trials of HCC and has encouraging survival effects with minimal toxicities. Randomized trials have yet to be performed. Vitamin K has been assessed in clinical trials at high dosage for its HCC-inhibitory actions. This idea is based on the characteristic biochemical defect in HCC of elevated plasma levels of immature prothrombin (DCP or PIVKA-2), due to a defect in the activity of prothrombin carboxylase, a vitamin K–dependent enzyme. Two vitamin K randomized controlled trials from Japan show decreased tumor occurrence. Patient participation in clinical trials aimed at assessing new therapies is encouraged. . Chapter 088. Hepatocellular Carcinoma (Part 8) Table 88- 5 Some Randomized Clinical Trials Involving Transhepatic Artery Chemoembolization (TACE) for Hepatocellular Carcinoma