The Launch Meeting of Clinical Research on Huaier Granule in the Treatment of Non-small Cell Lung Cancer Held in Ning

On the morning of April 2, 2017, a randomized, double-blind, placebo parallel-controlled, multi-center clinical trial of Huaier Granules for the prevention of recurrence and metastasis of stage II-Ш a non-small cell lung cancer after adjuvant chemotherapy and the simultaneous registration of patients without adjuvant chemotherapy after surgery The start-up study was successfully held in Shangri-La Hotel, Nanjing. This is another major scientific research project implemented by Qidong Gaitianli Pharmaceutical Co., Ltd. after the multi-center project of liver cancer. It is jointly organized by the first affiliated Hospital of Anhui Medical University, the bidding unit Qidong Gaitianli Pharmaceutical Co., Ltd., the contract research organization Beijing Qihuang Drug Clinical Research Center, the statistical unit Tongji Medical College of Huazhong University of Science and Technology, Hangzhou Ikoff Technology Co., Ltd., the data management and test product management provider, and Beijing Zero Krypton Technology Co., Ltd., a follow-up support unit. Researchers from 24 clinical research units across the country attended the meeting.

The meeting was presided over by Sun Guoping, president of the First Affiliated Hospital of Anhui Medical University, the main researcher, and introduced the overall goal and significance of clinical research on Huaier Granule in the treatment of non-small cell lung cancer. Primary lung cancer is one of the most common malignant tumors, and the incidence and mortality of lung cancer are on the rise in the world, especially in developing countries. In China, due to various factors, the incidence and mortality of lung cancer has been ranked first in all malignant tumors. Lung cancer first surgery, radical surgery is still the only possible cure of the treatment, but many patients at the time of diagnosis has been advanced, lost the opportunity of surgery, the need for chemotherapy. Huaier Granule has been on the market for many years and has been widely used in tumor clinic. It has a positive therapeutic effect in its treatment, which can significantly improve the quality of life of patients and enhance cellular immune function, thereby improving the therapeutic effect.

Lu Zhengxin, deputy general manager of Qidong Gaitianli Pharmaceutical Co., Ltd., introduced the advantages of Huaier granules, including effectiveness, safety, quality stability and the latest research results. We expect satisfactory results from high-quality lung cancer clinical trials.

Director Du Yingying of the First Affiliated Hospital of Anhui Medical University introduced the research scheme, technical route and the links that need attention in the research. Professor Yin Ping, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, made an exchange presentation on statistical design and central stochastic system. Hou Meijia, Project Manager of Beijing Qihuang Company, elaborated on GCP requirements, project management and overall plan for international registered clinical studies. The manager of Hangzhou Ikov Company, Jin Yiqun, briefly described the EDC system. Manager Liu Fang of Beijing Zero Krypton Company explained the telephone follow-up system used in the subject. In order to ensure the high quality and high specifications of the project, an independent data safety monitoring committee and an independent film reading committee have been established, and they have been registered on the clinicaltrials.gov website. I believe that with these strong multi-party technical support, the research quality of lung cancer topics will definitely be guaranteed.

I wish the lung cancer project a smooth progress and complete success.