|Table of Contents|

Endoscopic treatment with sustained-release cisplatin for implant of advanced esophageal cancer：A phase Ⅱa clinical trail

Journal Of Modern Oncology[ISSN:1672-4992/CN:61-1415/R]

Issue:
2017 01
Page:
51-56
Research Field:
Publishing date:

Info

Title:
Endoscopic treatment with sustained-release cisplatin for implant of advanced esophageal cancer：A phase Ⅱa clinical trail
Author(s):
Wang Yizhuo1; Zhang Weiqi2; Yao Liping1; Xie Huahong1; Xu Jianjian3; Zhang Yujie1; Zhang Hongbo1
1.Xijing Hospital of Digestive Disease，Fourth Military Medical University，Shaanxi Xi'an 710032，China；2.Xijing Hospital of Radiology Department，Fourth Military Medical University，Shaanxi Xi'an 710032，China；3.Hefei University of Technology Institute of Medical Engineering,Anhui Hefei 230000，China.
Keywords:
esophageal cancer; implant; sustained-release cisplatin
PACS:
R735.1
DOI:
10.3969/j.issn.1672-4992.2017.01.014
Abstract:
Objective：To observe the safety and efficacy of sustained-release cisplatin for implant in the treatment of advanced esophageal cancer，and explore the suitable dose of its clinical application.Methods：The present study was a prospective，multicenter and single-arm phaseⅡa clinical trial，and 24 to 32 patients were planned to be enrolled.Department of gastroenterology in Xijing hospital was one of the sub-centers，15 patients were included.In the 15 patients，2 cases were administrated with 60mg dose，4 with 80mg，and 9 with 100mg.Blood biochemistry，liver and kidney function were examined respectively before implant，1 week and 4 weeks after implant，and drug related adverse reactions were observed.Endoscopy，CT and esophageal barium meal examination were conducted before enrolled.Review above items at the fourth week，and judge the recent curative effect by reference to WHO solid tumor curative effect evaluation standard.Results：13 cases of 15 patients completed all the trial processes and their tolerance and adverse reactions could be evaluated.There were no adverse reactions with III to IV degree.The occurred symptomatic adverse events were less than II degree.62.5% patients of 100mg dose group had gotten chest pain.The results of 10 cases with evaluable tumor volume showed that DCR(disease control rate）was 90%(9/10).Based on the efficacy，adverse reactions and complications results，we would suggest a drug clinical trials unit as 20mg dose implantation per 1cm for a lever in future phase III clinical trial.Conclusion：Implanting sustained-release cisplatin particles guided by endoscopy on the edge and in the esophageal tumor of advanced esophageal cancer，brought distinct curative effect and showed better clinical tolerance.For esophageal cancer patients with dysphagia，who were not suitable for operation，obstruction symptoms could be relieved through the present treatment.

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Last Update: 2016-12-01