Transarterial chemotherapy alone versus transarterial chemoembolization for hepatocellular carcinoma: A randomized phase III trial

Takuji Okusaka, Hiroshi Kasugai, Yasukazu Shioyama, Katsuaki Tanaka, Masatoshi Kudo, Hiromitsu Saisho, Yukio Osaki, Michio Sata, Shigetoshi Fujiyama, Takashi Kumada, Keiko Sato, Seiichiro Yamamoto, Shiro Hinotsu, Tosiya Sato

Research output: Contribution to journalArticlepeer-review

83 Citations (Scopus)


Background/Aims: Transcatheter arterial chemoembolization (TACE) is a combination of transarterial infusion chemotherapy (TAI) and embolization, and has been widely used to treat patients with hepatocellular carcinoma (HCC). However, since the impact of adding embolization on the survival of patients treated with TAI had never been evaluated in a phase III study, we conducted a multi-center, open-label trial comparing TACE and TAI to assess the effect of adding embolization on survival. Methods: Patients with newly diagnosed unresectable HCC were randomly assigned to either a TACE group or a TAI group. Zinostatin stimalamer was injected into the hepatic artery, together with gelatin sponge in the TACE group and without gelatin sponge in the TAI group. Treatment was repeated when follow-up computed tomography showed the appearance of new lesions in the liver or re-growth of previously treated tumors. Results: Seventy-nine patients were assigned to the TACE group, and 82 were assigned to the TAI group. The two groups were comparable with respect to their baseline characteristics. At the time of the analysis, 51 patients in the TACE group and 58 in the TAI group had died. The median overall survival time was 646 days in the TACE group and 679 days in the TAI group (p = 0.383). Conclusions: The results of this study suggest that treatment intensification by adding embolization did not increase survival over TAI with zinostatin stimalamer alone in patients with HCC.

Original languageEnglish
Pages (from-to)1030-1036
Number of pages7
JournalJournal of Hepatology
Issue number6
Publication statusPublished - Dec 2009
Externally publishedYes


  • Gelatin sponge
  • Lipiodol emulsion
  • Overall survival
  • Survival benefit
  • Zinostatin stimalamer

ASJC Scopus subject areas

  • Hepatology


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