Status:
UNKNOWN
Plasma Biomarker for Aflibercept in Advanced Colorectal Cancer
Lead Sponsor:
Yonsei University
Conditions:
Recurrent or Metastatic Colorectal Cancer
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
Based on the pervious data, aflibercept in combination with FOLFIRI is one of the effective 2nd line treatment option in advanced colorectal cancer. In this study, we prospectively assess the efficacy...
Detailed Description
This is a prospective, multicenter, open-label, single arm study. Patients will be considered "on study" upon signing the written informed consent form (ICF). The study consists of a baseline period, ...
Eligibility Criteria
Inclusion
- Patient is an adult, ≥ 19 years old at the time of informed consent
- Patient has histologically confirmed advanced adenocarcinoma of colon or rectum
- Patients who were failed in only one treatment with target agent (anti-EGFR Ab or anti-VEGF Ab) combined with FOLFOX
- At least one measurable disease, as defined by RECIST version 1.1
- ECOG PS of 0 to 2.
- Life expectancy ≥ 3 months.
- Acceptable hematologic status (without growth factor support or transfusion dependency):
- ANC ≧ 1.5 x 109/L,
- Platelet count ≧100 x 109/L
- Hemoglobin ≧9.0 g/dL.
- Acceptable liver function:
- Bilirubin ≤ 1.0 x upper limit of normal(ULN)
- AST, ALT ≤ 2.5 x ULN or ≤ 5.0 x ULN in case of liver metastasis
- Serum creatinine ≤ 1.0 x UNL
- Patients who understand study protocol and signed informed consents.
Exclusion
- Previous therapy with other VEGFR inhibitors (other than bevacizumab) or irinotecan
- Patients who have serious underlying co-morbidities which could cause end-organ dysfunction, interfere with the conduct of the study, or that would pose an unacceptable risk to the subject in this study. in the opinion of the Investigator
- Contraindications to the use of FOLFIRI or aflibercept
- Female patients who are pregnant or breast feeding, or male/female patients of reproductive potential who are not willing to employ effective birth control
- Patients who are unable to read the study consent
Key Trial Info
Start Date :
April 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT04810585
Start Date
April 20 2020
End Date
October 1 2025
Last Update
March 23 2021
Active Locations (1)
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1
Yonsei University
Seoul, South Korea