A randomized phase II trial of intra-arterial chemotherapy using SM-11355 (Miriplatin) for hepatocellular carcinoma

Takuji Okusaka, Hiroshi Kasugai, Hiroshi Ishii, Masatoshi Kudo, Michio Sata, Katsuaki Tanaka, Yasukazu Shioyama, Kazuaki Chayama, Hiromitsu Kumada, Masaharu Yoshikawa, Toshihito Seki, Hidetugu Saito, Naoaki Hayashi, Keiko Shiratori, Kiwamu Okita, Isao Sakaida, Masao Honda, Yukio Kusumoto, Takuya Tsutsumi, Kenji Sakata

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30 Citations (Scopus)


Background SM-11355 is a platinum complex developed to treat hepatocellular carcinoma (HCC) via administration into the hepatic artery as a sustained-release suspension in iodized oil. We conducted a multicenter phase II trial in patients with HCC to evaluate the efficacy and safety of SM-11355, using a Zinostatin stimalamer suspension in iodized oil as a reference. Methods Patients with unresectable HCC were randomized 2:1 to receive administration of the SM-11355 or Zinostatin stimalamer suspension into the hepatic artery. A second injection was given 4-12 weeks later. Efficacy was evaluated by CT 3 months after treatment and categorized as therapeutic effect (TE) V to I, where TE V was defined as disappearance or 100% necrosis of all treated tumors. Results A total of 122 patients were evaluated for efficacy and toxicity (SM-11355, n=83; Zinostatin stimalamer, n=39). Baseline characteristics were similar in the two groups. The TE V rates were 26.5% (22/83) and 17.9% (7/39) in the SM-11355 and Zinostatin stimalamer groups, respectively. In the SM-11355 group,the most frequent drug-related adverse events (AEs) of≥grade 3 were elevated AST, elevated ALT, thrombocytopenia, and hyperbilirubinemia. The AEs with the largest difference between the two groups (SM-11355 vs. Zinostatin stimalamer) were hepatic vascular injury (0 vs. 48.4%) and eosinophilia (84.3 vs. 41.0%). The 2-year and 3-year survival rates were 75.9% vs. 70.3% and 58.4% vs. 48.7%, respectively. Conclusions The results suggest that SM-11355 in iodized oil has similar efficacy to Zinostatin stimalamer and that repeated dosing of SM-11355 is possible without hepatic vascular injury in cases of relapse.

Original languageEnglish
Pages (from-to)2015-2025
Number of pages11
JournalInvestigational new drugs
Issue number5
Publication statusPublished - 2012 Oct
Externally publishedYes


  • Iodized oil
  • Liver cancer
  • Parallel study
  • Suspension

ASJC Scopus subject areas

  • Oncology
  • Pharmacology
  • Pharmacology (medical)


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