Chlorogenic acid (CHA) is a class 1 innovative small molecular natural drug, developed by Sichuan Jiuzhang Biological Science and Technology Co., Ltd. The mechanism of broad-spectrum antitumor activity is immunoregulation. After received the clinical trial approval issued by CFDA, Jiuzhang Biotech successfully finished the phase I clinical studies of CHA for injection in advanced GBM patients, focus on safety, PK, and preliminary efficacy evaluation.~The results of phase I data showed that CHA had good safety, the main adverse effect was induration, no other serious adverse effects. PK exhibited that CHA had a rapid metabolism character (t1/2 = 1-1.5 h). In addition, there were no accumulative side effects for long-term use. To the investigators' surprise, the preliminary efficacy evaluation was amazing, there were 1 case CR and 1 case PR. The median OS of grade IV GBM patients was 21.4 months in effective dose group, which was much better than that of the historical reported data.The purpose of phase II/III study: Determining the Overall Survival（OS）of Chlorogenic acid for injection comparing to in the advanced Glioblastoma Patients through study completion（an average of 18 months）after the first dose of chlorogenic acid for injection and Lomustine .
The purpose of phase II/III study: Determining the Overall Survival（OS）of Chlorogenic acid for injection comparing to in the advanced Glioblastoma Patients through study completion（an average of 18 months）after the first dose of chlorogenic acid for injection and Lomustine.