40
Participants
Start Date
November 30, 2012
Primary Completion Date
November 30, 2014
Study Completion Date
December 31, 2015
Nimotuzumab
single dose of nimotuzumab (100、200、400、600mg), with 3 weeks observation;Set 4 dose groups for Nimotuzumab, namely 100,200,400,600mg. Each group administered once a week for 6 weeks;600mg, administered once every 2 weeks for 8 weeks.
irinotecan
"Single-dose PK:1 week after nimotuzumb administration, irinotecan (CPT-11) will be given at a dose of 180 mg/m2 once every 2 weeks, 2 weeks a cycle.~Bioweekly fixed dose PK:Nimotuzumab combined with irinotecan (180mg/m2), administering once every 2 weeks and considering 2 weeks as a period. If chemotherapy and Nimotuzumab are administered in the same day, chemotherapy should be infused after Nimotuzumab for at least 1h"
Cancer Institute & Hospital, Chinese Academy of Medical Sciences, Beijing
Lead Sponsor
Biotech Pharmaceutical Co., Ltd.
OTHER