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Gefitinib and Berberine in the First-line Treatment of Lung Adenocarcinoma With EGFR Mutation — Geber  

Lung Adenocarcinoma Clinical Trial

Official title:
An Open-label Phase II Trial of Gefitinib and Berberine in Patients With Advanced Non-small Cell Lung Cancer and Activating EGFR Mutations

Clinical Trial Summary

Rationale:

Advanced non-small-cell lung cancer (NSCLC) patients harboring epidermal growth factor receptor (EGFR) mutations (del19 or L858R) show an impressive progression-free survival between 9 and 11 months when treated with gefitinib. Combination of gefitinib and berberine could improve efficacy in lung cancer with EGFR mutation in vivo and vitro. The investigators hypothesize that progression-free survival could be improved by combination of gefitinib and berberine.

Clinical Trial Description

Strong lipogenic activity and high expression of sterol regulatory element-binding protein 1 (SREBP-1) were found in gefitinib-resistance NSCLC cells. Berberine, an effective suppressor of SREBP1 and lipogenesis regulated through ROS/AMPK pathway, selectively inhibited the growth of gefitinib-resistance NSCLC cells but not that of normal cells. It effectively caused mitochondrial dysfunction, activated reactive oxygen species (ROS)/AMPK pathway and finally suppressed cellular lipogenesis and cell proliferation. Addition of ROS blocker, AMPK inhibitor and palmitic acid significantly reduced the effect of Berberine. In in vivo study, treatment of Berberine led to significant inhibition of mouse tumor xenograft growth. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03486496
Study type Interventional
Source Fujian Cancer Hospital
Contact Gen Lin, Dr.
Phone 00861-591-83660063
Email lingen197505@163.com
Status Not yet recruiting
Phase Phase 2
Start date June 5, 2018
Completion date February 1, 2020
View Details
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