KCT0004757Recruiting未知
Efficacy and Biomarker exploration of 2nd line Aflibercept in combination with FOLFIRI in advanced colorectal cancer
Yonsei University Health System, Severance Hospital0 sites153 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Enrollment
- 153
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional Study
Eligibility Criteria
- Ages
- 19?(Year) to 100?(Year) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Investigators
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