drugset / Trial / NCT04810585

Plasma Biomarker for Aflibercept in Advanced Colorectal Cancer

NCT04810585

Phase 4 Unknown 153 enrolled Yonsei University
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2020-04-20
Primary completion
2025-10
Completion
2025-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Aflibercept Protein / enzyme biologic 4 mg/kg Intravenous
Background Irinotecan Small molecule 150 mg/m2 Intravenous
Background Leucovorin Small molecule 400 mg/m2 Intravenous
Background fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications