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

A Randomized Controlled Study of Immunochemotherapy With OK-432 After Curative Surgery for Gastric Cancer

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Clinical Trial

A Randomized Controlled Study of Immunochemotherapy With OK-432 After Curative Surgery for Gastric Cancer

Yuji Sato et al. J Immunother. .

Abstract

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).

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