Plasma Biomarker for Aflibercept in Advanced Colorectal Cancer

Launched by YONSEI UNIVERSITY · Mar 18, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called aflibercept when combined with another treatment known as FOLFIRI for patients with advanced colorectal cancer, which is cancer that has either returned or spread to other parts of the body. The goal is to see how well this combination works in helping patients live longer without their cancer getting worse. Researchers will also look at different blood markers to understand how the treatment impacts the patients' health and survival.

To participate in this study, you need to be at least 19 years old and have a confirmed diagnosis of advanced colon or rectal cancer. You should have previously received one type of treatment but not more, and you should have measurable cancer that doctors can track. Participants can expect to undergo regular check-ups and tests to monitor their health during the trial. It's important to note that some patients may not be eligible, such as those with certain health issues or those who have received specific other cancer treatments before. If you think you might qualify and are interested, please discuss it with your doctor.

Gender

ALL

Eligibility 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