Phase II study on safety and efficacy of Yadanzi® (Javanica oil emulsion injection) combined with chemotherapy for patients with gastric cancer.

OBJECTIVE To investigate the efficacy and safety of Yadanzi® (Javanica oil emulsion injection) combined with chemotherapy for treatment of patients with advanced gastric cancer. METHODS From January 2011 to December 2012, we recruited 75 patients with advanced gastric cancer, who received javanica oil emulsion injection together with chemotherapy. After two cycles of treatment, efficacy and safety of the combined therapies were evaluated. RESULTS Overall response rate of 75 patients after treatment was 85.3% (CR+PR+SD). Treatment related side effects were recorded. No treatment related death occurred. CONCLUSIONS Javanica oil emulsion injection combined with chemotherapy could be considered as a safe and effective regimen in treating patients with advanced gastric cancer. Further randomized clinical trials should be conducted to confirm whether the addition of Yadanzi® to chemotheraphy could be associated with reduced toxicity, enhanced tolerability and improved quality of life for patients with advanced gastric cancer.