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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04835142
Other study ID # KL140-?-02-CTP
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date February 24, 2021
Est. completion date April 30, 2023

Study information

Verified date March 2021
Source Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Contact Jianming Xu, Professor
Phone 13910866712
Email jmxu2003@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Compare the objective remission rate of A140 and Erbitux combined with mfolfox6 regimen in the first-line treatment of Ras wild-type metastatic colorectal cancer for 12 weeks


Description:

In this study, a multicenter, randomized, double-blind, controlled trial design was used to compare the efficacy and safety of A140 or Erbitux combined with mfolfox6 regimen in the first-line treatment of Ras wild-type metastatic colorectal cancer patients Objective to compare the 12 week objective response rate (ORR) of A140 and ebitur combined with mfolfox6 regimen in the first-line treatment of Ras wild-type metastatic colorectal cancer.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Double blind control period A140
experiment arm: Drug A140:400 mg/m2(D1,iv),250 mg/m2(qw,iv) Drug Oxaliplatin 85 mg/m2(D1,iv), Drug Calcium Folinate 400 mg/m2(D1,iv) Drug 5-FU 400 mg/m2(D1,iv),2400 mg/m2 (48±4h) control arm: Drug Erbitux:400 mg/m2(D1,iv),250 mg/m2(qw,iv) Drug Oxaliplatin 85 mg/m2(D1,iv) Drug Calcium Folinate 400 mg/m2(D1,iv) Drug 5-FU 400 mg/m2(D1,iv),2400 mg/m2 (48±4h)
Open single period A140
Drug A140:400 mg/m2(D1,iv),250 mg/m2(qw,iv) Drug Oxaliplatin 85 mg/m2(D1,iv), Drug Calcium Folinate 400 mg/m2(D1,iv) Drug 5-FU 400 mg/m2(D1,iv),2400 mg/m2 (48±4h)

Locations

Country Name City State
China 307 Hospital of PLA Beijing Beijing
China 307 Hospital of PLA Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary ORR The objective tumor response rate (ORR) of colorectal cancer patients at 12 weeks based on the evaluation of the independent imaging evaluation committee, and confirmed at least 4 weeks later 16 Weeks
Secondary ORR 1)Based on the researcher's assessment of the objective tumor response rate (ORR) of patients with colorectal cancer after 12 weeks of medication, and confirmed at least 4 weeks later 16 Weeks
Secondary Progression-free survival (PFS) 2)PFS within 1 year after medication based on the evaluation by the independent imaging evaluation committee and the investigator PFS-1 year
Secondary Overall survival (OS) 2) OS within 1 year after medication based on the evaluation by the independent imaging evaluation committee and the investigator OS-1year
Secondary Progression-free survival (PFS) 3)Based on the researcher's assessment of PFS after 1 year of medication PFS-1 year after the last patient's first dose
Secondary Overall survival (OS) 3)Based on the researcher's assessment of OS after 1 year of medication OS-1 year after the last patient's first dose
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