A 40 Month Double-Blind, Randomized, Placebo-Controlled Trial on the Effect of BCc1 Nanomedicine on Survival of Metastatic and Non-Metastatic Gastric Cancer Patients

Abstract Background: Complementary experiments on nanomedicines as proper candidates for the control and treatment of cancer are widely being conducted nowadays. In the previous study, the effect of BCc1 nanomedicine, which is synthetized based on nanochelating technology, on overall survival (OS) and quality of life of gastric cancer patients was evaluated after 18 months of consumption. The OS of the same patients is reported in this study after 40 months. Methods: A double-blind, randomized, placebo-controlled, parallel, multicenter design was used in this study. 123 metastatic and non-metastatic gastric cancer patients of both genders (between 25 and 85 years old) participated in this experiment to evaluate their OS after consuming BCc1 for 40 months and to identify the adverse events of this nanomedicine. Results: The median OS of metastatic patients was 257 days in the BCc1 group [95% confidence interval (CI): 144. 142-369.858], while it was 161 days in the placebo [95% CI: 118.462-203.538]; hazard ratio (HR): 0.802 [95% CI: 0.483-1.333] (P-Value = 0.395). Similarly, the median OS of non-metastatic patients was 718 days in the BCc1 group [95% CI; 577.706-860.213], while it was 520 days in the placebo [95% CI: 460.280- 580.690]; HR: 0.807 [95% CI: 0.343,1.902] (P-Value = 0.624). There was no evidence of adverse events after 40 months.Conclusion: The OS improvement of metastatic and non-metastatic gastric cancer patients in the previous (18 months of follow-up) and current (40 months of follow-up) studies showed that BCc1 can be used along with base treatments to improve cancer patients’ OS. Trial registration: IRCTID, IRCT2017101935423N1.Registered on 19 October 2017, http://www.irct.ir/ IRCT2017101935423N1.