Efficacy exploration of 2nd line in advanced colorectal cancer
- Conditions
- Neoplasms
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 153
1) Patient is an adult, = 19 years old at the time of informed consent
2) Patient has histologically confirmed advanced adenocarcinoma of colon or rectum
3) Patients who were failed in only one treatment with target agent (anti-EGFR Ab or anti-VEGF Ab) combined with FOLFOX
4) At least one measurable disease, as defined by RECIST version 1.1
5) ECOG PS of 0 to 2.
6) Life expectancy = 3 months.
7) Acceptable hematologic status (without growth factor support or transfusion dependency):
a. ANC ?1.5 x 109/L,
b. Platelet count ?100 x 109/L
c. Hemoglobin ?9.0 g/dL.
8) Acceptable liver function:
a. Bilirubin = 1.0 x upper limit of normal(ULN)
b. AST, ALT = 2.5 x ULN or = 5.0 x ULN in case of liver metastasis
9) Serum creatinine = 1.0 x UNL
10) Patients who understand study protocol and signed informed consents.
1) Previous therapy with other VEGFR inhibitors (other than bevacizumab) or irinotecan
2) 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
3) Contraindications to the use of FOLFIRI or aflibercept
4) Female patients who are pregnant or breast feeding, or male/female patients of reproductive potential who are not willing to employ effective birth control
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Profression free survival
- Secondary Outcome Measures
Name Time Method Overall survival (OS);objective response rate (ORR);safety profile;biomarker study