A randomized controlled study of immunochemotherapy with OK-432 after curative surgery for gastric cancer

J Immunother. 2004 Sep-Oct;27(5):394-7. doi: 10.1097/00002371-200409000-00008.


The effect of adjuvant immunochemotherapy including OK-432 (Picibanil) on survival was assessed in patients who underwent curative resection of gastric cancer. Patients enrolled in this randomized controlled study were randomly assigned to group A or group B. Group A patients received 800 mg/d 5'-DFUR (Furtulon) for 2 years from 2 weeks after the operation. Group B patients received OK-432 plus 5'-DFUR by the same regimen as in group A. This study enrolled 288 patients, and 1 patient with malignant lymphoma was excluded. Among the remaining 287 patients, 143 and 144 were allocated to group A and group B, respectively, and their data were included in statistical analysis. The 5-year survival rates for groups A and B were 62.9% and 63.8%, respectively, showing no significant difference (P = 0.7996).

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Antimetabolites, Antineoplastic / therapeutic use
  • Antineoplastic Agents / therapeutic use*
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Chemotherapy, Adjuvant
  • Female
  • Floxuridine / therapeutic use
  • Humans
  • Immunotherapy*
  • Male
  • Middle Aged
  • Picibanil / therapeutic use*
  • Stomach Neoplasms / drug therapy*
  • Stomach Neoplasms / mortality
  • Survival Analysis


  • Antimetabolites, Antineoplastic
  • Antineoplastic Agents
  • Floxuridine
  • Picibanil
  • doxifluridine