Author:
Hafizi Maryam,Kalanaky Somayeh,moaiery Hassan,Khayamzadeh Maryam,Noorian Sajad,Kaveh Vahid,Gharib Behrooz,Foudazi Hossein,Razavi Mohsen,Jenabian Arash,Salimi Saeid,Sereshki Mohammad Mahdi Adib,Mirzaei Hamid Reza,Zarghi Afshin,Fakharzadeh Saideh,Nazaran Mohammad Hassan,Akbari Mohammad Esmaeil
Abstract
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
Publisher
Springer Science and Business Media LLC
Subject
Pharmaceutical Science,Applied Microbiology and Biotechnology,Biomedical Engineering,Molecular Medicine,Medicine (miscellaneous),Bioengineering
Reference43 articles.
1. Cancer - World Health Organization. http://www.who.int/news-room/fact-sheets/detail/cancer.
2. American Cancer Society. https://www.cancer.org/cancer/acs-medical-content-and-news-staff.html).
3. Gu Y, et al. LncRNAs: emerging biomarkers in gastric cancer. Future Oncol. 2015;11(17):2427–41.
4. Xu W, Yang Z, Lu N. Molecular targeted therapy for the treatment of gastric cancer. J Exp Clin Cancer Res. 2016;35:1.
5. https://seer.cancer.gov/statfacts/html/stomach.html.
Cited by
18 articles.
订阅此论文施引文献
订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献