A randomized, double-blind, placebo-controlled investigation of BCc1 nanomedicine effect on survival and quality of life in metastatic and non-metastatic gastric cancer patients

Abstract

Background Currently, 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. Methods The 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. Results In 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. Conclusion The 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 Electronic supplementary material The online version of this article (10.1186/s12951-019-0484-0) contains supplementary material, which is available to authorized users.

Transgelins: Cytoskeletal Associated Proteins Implicated in the Metastasis of Colorectal Cancer

“…CRC is generally asymptomatic until it reaches an advanced stage, and more than 25% of CRC patients have lymph node or even distant metastasis at initial diagnosis (stage IV) ( Tauriello et al, 2017 ; Sterpetti et al, 2020 ). Metastasis is the main cause of death in patients with CRC ( Van Cutsem et al, 2018 ; Hafizi et al, 2019 ), among which liver and lung metastasis account for approximately 60 and 30% of these deaths, respectively ( Wang et al, 2018 ; Li et al, 2019 ; Kasprzak and Adamek, 2020 ). CRC metastasis is a multihit, multistage process, but there is a lack of effective treatments for CRC metastasis ( Wei et al, 2019 ); therefore, the identification of molecular biomarkers associated with CRC metastasis is critical for the subsequent treatment of CRC and extending patient survival.…”

<p>BCc1 Nanomedicine Therapeutic Effects in Streptozotocin and High-Fat Diet Induced Diabetic Kidney Disease</p>

“…[14][15][16][17] In the previous studies, anti-neoplastic effects of BCc1 nanomedicine with iron-chelating property were demonstrated in several experiments. 19,20,47 In the present study, this nanomedicine was tested in animal model of DKD to evaluate its impacts on various biochemical and histopathological parameters of this disease.…”

“…19 In addition, in a randomized, double-blind, placebocontrolled study, overall survival and quality of life in gastric cancer patients were significantly improved by BCc1. 20 One important feature of BCc1 is its iron-chelating property. 19 In light of this fact and based on the demonstrated role of iron metabolism changes in chronic diseases, especially in DKD, and the effects of iron chelators in chronic diseases, in the present study, the effects of BCc1 on pathological events in DKD using the experimental model of kidney disease induced by streptozotocin and a high-fat diet were assessed.…”

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

“…Recent progress in the elds of materials and nanotechnology has resulted in signi cant improvements in the design of nanomedicines [1]. Nanomedicines are now considered signi cantly helpful in the successful delivery of therapeutic chemicals to tumor sites in cancer patients [2][3][4]. The current advances in nanomedicines have led to their broader application in clinical trials.…”