On July 2, 2017, the 8th Steering Committee of the AXEPT trial took place at Sun Yat-sen Cancer Center (SYSUCC). The AXEPT trial is an investigator-initiated, large-scale, multinational, randomized, Phase III clinical trial involving a total of 98 centers, comparing the efficacy and safety of capecitabine plus irinotecan (XELIRI), versus 5-FU/LV plus irinotecan as a second-line treatment for metastatic colorectal cancer. Principal Investigators Prof. Rui-Hua Xu (China), Prof. Kei Muro (Japan), and Prof. Tae Won Kim (South Korea), and associates, attended the meeting. The meeting was chaired by Prof. Junichi Sakamoto from the NPO Epidemiological and Clinical Research Information Network (ECRIN).
Prof. Sakamoto reported on the current status of the trial, and proposed an action plan. It was followed by in-depth discussions about scientific practice, patient inclusion criteria, future schedules, presentation and publication targets and prospects. Prof. Sakamoto also shared a detailed report of the centers involved in the study. The results indicated that overall the research data from all three participating countries is of high quality.
Left to right: Prof. Tae Won Kim, Prof. Ruihua Xu, Prof. Junichi Sakamoto and Prof. Kei Muro
Prof. Rui-Hua Xu concluded the meeting with these words: “Due to the lack of funding from industries, investigator-initiated trials are generally difficult to conduct and manage, particularly in China. Thanks to the comprehensive arrangement and management by the ECRIN center, the AXEPT trial has been successfully carried out. Chinese investigators should draw on the successful experiences of clinical trials abroad, improve data-monitoring and trial-management systems, guarantee authenticity, scientific integrity, the practicability of clinical trials, and ultimately bring Chinese investigator-initiated trials up to an international standard.”
Reported by Dr. Zi-Xian Wang from the Department of Medical Oncology, Sun Yat-Sen University Cancer Center