Abstract
BackgroundCurrently, the main goal of cancer research is to increase longevity of patients suffering malignant cancers. The promising results of BCc1 in vitro and vivo experiments made us look into the effect of BCc1 nanomedicine on patients with cancer in a clinical trial.MethodsThe present investigation was a randomized, double-blind, placebo-controlled, parallel, and multicenter study in which 123 patients (30-to-85-year-old men and women) with metastatic and non-metastatic gastric cancer, in two separate groups of BCc1 nanomedicine or placebo, were selected using a permuted block randomization method. For metastatic and non-metastatic patients, a daily dose of 3000 and 1500 mg was prescribed, respectively. Overall survival (OS) as the primary endpoint and quality of life (measured using QLQ-STO22) and adverse effects as the secondary endpoints were studied.ResultsIn metastatic patients, the median OS was significantly higher in BCc1 nanomedicine (174 days [95% confidence interval (CI) 82.37–265.62]) than in placebo (62 days [95% CI 0–153.42]); hazard ratio (HR): 0.5 [95% CI 0.25–0.98; p = 0.046]. In non-metastatic patients, the median OS was significantly higher in BCc1 nanomedicine (529 days [95% CI 393.245–664.75]) than in placebo (345 days [95% CI 134.85–555.14]); HR: 0.324 [95% CI 0.97–1.07; p = 0.066]. The QLQ-STO22 assessment showed a mean difference improvement of 3.25 and 2.29 (p value > 0.05) in BCc1 nanomedicine and a mean difference deterioration of − 4.42 and − 3 (p-value < 0.05) in placebo with metastatic and non-metastatic patients, respectively. No adverse effects were observed.ConclusionThe findings of this trial has provided evidence for the potential capacity of BCc1 nanomedicine for treatment of cancer.Trial registration IRCTID, IRCT2017101935423N1. Registered on 19 October 2017, http://www.irct.ir/ IRCT2017101935423N1
Highlights
The main goal of cancer research is to increase longevity of patients suffering malignant cancers
BCc1 nanomedicine was designed based on the nanochelating technology for cancer treatment experimented in vitro and vivo studies and the results showed that BCc1 has high potentials to induce therapeutic behavior [8]
According to some data in 2013–2015, almost 0.8% of people will be diagnosed with stomach cancer at some point in their lifetime, so we investigated the effects of this nanomedicine in patients with gastric cancer [2]
Summary
The main goal of cancer research is to increase longevity of patients suffering malignant cancers. The promising results of BCc1 in vitro and vivo experiments made us look into the effect of BCc1 nanomedicine on patients with cancer in a clinical trial. In 2018, 1,735,350 new cancer cases and 609,640 cancer deaths are calculated to happen in the US [2]. Based on the National Cancer Database, in the United States, the overall 5-year (2008– 2014) relative survival rate of patients having stomach cancer was about 31% [2], new stomach cancer cases were 7.2 per 100,000 people per year and the death toll was 3.2 per 100,000 people per year in 2011–2015 [5]. Over half of gastric cancer deaths happen in the first year of diagnosis in Iran and another 30% during the second year of diagnosis. The results show lower survival rates in Iran [7]
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