Phase I clinical study of a novel lipophilic platinum complex (SM-11355) in patients with hepatocellular carcinoma refractory to cisplatin/lipiodol
2003

Phase I Study of SM-11355 for Liver Cancer

Sample size: 11 publication Evidence: low

Author Information

Author(s): Fujiyama S, Shibata J, Maeda S, Tanaka M, Noumaru S, Sato K, Tomita K

Primary Institution: Kumamoto University School of Medicine

Hypothesis

Can the novel lipophilic platinum complex SM-11355 be safely administered to patients with hepatocellular carcinoma who are refractory to cisplatin/lipiodol?

Conclusion

The study found that SM-11355 shows promise for treating hepatocellular carcinoma, with one complete response and one partial response among the patients.

Supporting Evidence

  • One patient achieved a complete response and another a partial response.
  • Adverse effects included nausea, vomiting, and pyrexia, but were generally mild.
  • Patients had a history of cisplatin-lipiodol treatment that was ineffective in many cases.

Takeaway

Doctors tested a new cancer drug called SM-11355 on 11 patients with liver cancer, and it helped some of them feel better.

Methodology

Patients received SM-11355 via intra-arterial infusion, and their responses were evaluated based on tumor size and adverse effects.

Limitations

The study was small and included patients with advanced disease and a history of ineffective treatments.

Participant Demographics

Patients aged 20-75 with recurrent hepatocellular carcinoma, mostly male.

Digital Object Identifier (DOI)

10.1038/sj.bjc.6601318

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