The purpose of this study is to evaluate the efficacy and safety of recombinant anti-EGFR Monoclonal antibody(SCT200)in patients with wild-type RAS and BRAF mCRC treated with fluorouracil, oxaliplatin and irinotecan after failure of standard therapy
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
110
Experimental: recombinant anti-EGFR monoclonal antibody(SCT200) Recombinant Anti-EGFR Monoclonal Antibody(SCT200). Initially, SCT200 6.0mg/kg will be administered at day 1 every week for a maximum of 6 cycles. After 6 cycles SCT200 8.0mg/kg will be administered at day 2 every weeks until disease progression.
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Objective response rate
The achievement of either a partial response (PR) or complete response (CR), according to RECIST 1.1 criteria
Time frame: 1 year
Objective response rate - left side
The achievement of either a partial response (PR) or complete response (CR), left side mCRC patients treated by SCT200. according to RECIST 1.1 criteria
Time frame: 1 year
Best of response
Number of patients in each response category(CR, PR, SD, PD), according to RECIST 1.1 criteria
Time frame: 1 year
Duration of response
Defined as the time from the date that the response criteria are first met to the date that progressive disease (PD) is objectively documented or death, whichever occurs first.
Time frame: 1 year
Disease control rate
The achievement of any a stableresponse(SD), partial response (PR) or complete response (CR), according to RECIST 1.1 criteria
Time frame: 1 year
Time to response
Defined as the time from first dose of SCT200 to documentation of a response.according to RECIST 1.1 criteria
Time frame: 1 year
Progression free survival
Defined as time from first dose of SCT200 until first documentation of Progression or death, whichever comes first, according to RECIST 1.1 criteria
Time frame: 1 year
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Cancer hospital Chinese academy of medical sciences
Beijing, Beijing Municipality, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
The Sixth Affiliated Hospital Of Sun Yat-sen University
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital.
Zhengzhou, Henan, China
Hunan Cancer Hospital
Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
...and 11 more locations
Overall survival
Defined as the time from first dose of SCT200 until death.
Time frame: 1 year