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Clinical Trials/KCT0004757
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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