NCT04810585

Plasma Biomarker for Aflibercept in Advanced Colorectal Cancer

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 153 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, multicenter, open-label, single arm study. Patients will be considered "on study" upon signing the written informed consent form (ICF). The study consists of a baseline period, followed by a treatment period, consisting of 14-day treatment cycles, which will end by a 30-day Follow-up visit, which in turn, will be followed by a post-treatment follow-up period. Patients will be evaluated for PFS then be followed on study until death or until cut-off date for final analysis of OS has been reached, whichever comes first. During the 21-day baseline period, all baseline procedures will have to be performed within defined timelines, including review of eligibility criteria During the treatment period, the study treatment, aflibercept combined with FOLFIRI will be administered every 2 weeks unless a definitive treatment discontinuation criterion is met. Cycle lengths may be extended in case of unresolved toxicity. Imaging to document tumor response and progressive disease will take place every 6 weeks and will continue to be done during the follow-up period in case of early study treatment discontinuation (i.e. prior to documented progression). Once disease progression is documented, patients will be followed every 2 months for survival status and collection of data regarding further anticancer therapy, until death or until the study cutoff date, whichever comes first. The patients will be followed for safety for a minimum of 30 days following the last administration of the study treatment (30-day Follow-up visit). Beyond this date, all study drug related AEs and all SAEs should be followed until resolution/stabilization. Study drug-related AEs brought to the attention of the investigator at any time after the 30-day Follow-up visit should be recorded in the case report form (CRF).

Conditions

• Recurrent or Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Aflibercept + FOLFIRI	Day 1. Aflibercept + FOLFIRI * aflibercept(Zaltrap): 4 mg/kg IV infusion for over 1hr (Do not administer as an IV push or bolus) * Folinic acid: 400 mg/m2 IV infusion for over 2 hours * Irinotecan: 150 mg/m2 IV infusion for over 1 hours * 5-FU: 400 mg/m2 IV bolus injection for over 5 minute * 5-FU: 2400 mg/m2 IV continuous infusion for 46 hours every 2 weeks until progression disease or death or unacceptable toxicity

Timeline

• Start date: 2020-04-20
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2021-03-23
• Last updated: 2021-03-23

Locations

1 site across 1 country: South Korea