Using plasma biomarkers to assess aflibercept treatment in advanced colorectal cancer

Efficacy and Biomarker Exploration of 2nd Line Aflibercept in Combination With FOLFIRI in Advanced Colorectal Cancer

This study is testing if the combination of aflibercept and FOLFIRI can help people with advanced colorectal cancer live longer and feel better after their previous treatments.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 153 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Yonsei University (Academic / other)
• Drugs / interventions: bevacizumab
• Locations: 1 site (Seoul)
• Trial ID: NCT04810585 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of aflibercept combined with FOLFIRI as a second-line treatment for patients with advanced colorectal cancer. It is a prospective, multicenter, open-label, single-arm study that will assess progression-free survival and overall survival, along with various plasma biomarkers. Patients will undergo treatment cycles every two weeks, with imaging to monitor tumor response every six weeks. The study aims to gather data on safety and efficacy based on prior treatment types.

Who should consider this trial

Good fit: Ideal candidates are adults aged 19 and older with histologically confirmed advanced adenocarcinoma of the colon or rectum who have failed only one prior treatment.

Not a fit: Patients who have previously received therapy with other VEGFR inhibitors or irinotecan may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with advanced colorectal cancer who have not responded to first-line therapies.

How similar studies have performed: Other studies have shown promising results with similar treatment approaches, indicating potential for success in this study.

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

Where this trial is running

Seoul

• Yonsei University — Seoul, Korea, Republic of (Recruiting)

Study contacts

• Principal investigator: Joong Bae Ahn, MD, PhD — Severance Hospital
• Study coordinator: Joong Bae Ahn, MD, PhD

Conditions Recurrent or Metastatic Colorectal Cancer