Plasma Biomarker for Aflibercept in Advanced Colorectal Cancer

• Status: Recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: All

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 of 2nd line aflibercept in combination with FOLFIRI in advanced colorectal cancer in terms of progression-free survival. We further assess the efficacy according to the type of 1st line treatment. plasma biomarker study (HGF, VEGF-A, VEGF-D, IFN-γ, Angiopoietin-2, sICAM-1, sVCAM-1, TIMP-1, PIGF (HS), IL-6 (HS), IL-8 (HS), sNeuropilin-1, Thrombospondin-2 , Osteopontin , sVEGFR1, sVEGFR2, sVEGFR3) , overall survival (OS)OS, objective response rate (ORR), and safety are also assessed as the 2ndary objectives.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Treatments: Aflibercept

Criteria

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):

1. ANC ≧ 1.5 x 109/L,

2. Platelet count ≧100 x 109/L

3. Hemoglobin ≧9.0 g/dL.

8. Acceptable liver function:

1. Bilirubin ≤ 1.0 x upper limit of normal(ULN)

2. 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

5. Patients who are unable to read the study consent