Garcinia Acid Iia Clinical Summary Report

Objective:main aim:To observe cancer patients tolerability and safety profiles of gambogic acid intravenously by the different administration methods and explore the best one.Secondary aim:To initially observe objective effect in treatment of advanced cancer,in order to provide the candidate tumors for the PhaseⅡb clinical trial.Methods:A multicenter,open,random, no-controlled-trial,which divided into 2 groups,namely daily administration group(A 45mg/m~2 with Qd? repeat every 2 weeks) and daily alternative administration group(B 45mg/m~2 with Qd? repeat every 2 weeks),a cycle up to 14 days.The Evaluation of efficacy and safety of gambogic acid intravenously were made after 2 cycles.Results:The total 50 cases were enrolled,24 from A group and 26 from B group.The main side effects include injection site infusion reactions,gastrointestinal reaction and all were involved inⅠ—ⅡGrade.No severe side effect was found in both groups.In the course of studying,there was no significant difference between before and after administration in vital signs,liver function,renal function,blood routine examination and electrocardiograph.The whole incidence rate of the side effect was 40%,42.86%and 60.87%respectively in A and B group.The proportionⅡGrade of the total,A and B group was 52.27%,42.86%,60.87%.The total 47 of 50 cases were eligible for final analysis,the response were PR3,SD29,PD 15,included PR3,SD 14,PD4 from A group and SD16,PD7 from B group.The clinical remission rate was 6.38%,14.29%and 0%in group A and B, respectively.The clinical beneficial rate was 68.03%,76.19%and 61.54%in group A and B,respectively.The PR was 2 lung cancer cases,1 colon cancer case.In addition to,PR was performed in one renal cell carcinoma case which had accepted 6 cycles of extended access program by daily administration. Conclusion:Gambogic acid intravenously is a new antineoplastic drug with slight side effect and strong tolerability profile,which seemed promising in treatment advanced cancer and was worth further studying.Compared with degree and incidence rate of the side effect,A group was better than B group. Therefore,we recommended the administration method for PhaseⅡb clinical trial should be daily administration(45mg/m~2 with Qd? repeat every 2 weeks). Lung cancer,colon cancer case and renal cell carcinoma were proposed to study in PhaseⅡb clinical.