Plasma Biomarker for Aflibercept in Advanced Colorectal Cancer

Sponsor
Yonsei University
Study ID
NCT04810585
Phase
PHASE4
Status
Unknown

Conditions

  • Recurrent or Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aflibercept + FOLFIRI — DRUG
    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

Study Details

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.

Key Dates

Start date
Apr 20, 2020
Status verified
Mar 2021
Primary completion
Oct 31, 2025
Completion
Oct 31, 2025

Study Design

Enrollment
153 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment

Primary Outcome Measure

Progression free survival [ Time Frame: up to 5years ]

Central Contacts