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Plasma Biomarker for Aflibercept in Advanced Colorectal Cancer

NCT04810585 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2021-03-23

No results posted yet for this study

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.

Conditions

  • Recurrent or Metastatic Colorectal Cancer

Interventions

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

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Principal Investigators

  • Joong Bae Ahn, MD, PhD · Severance Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-20
Primary Completion
2025-10-31
Completion
2025-10-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04810585 on ClinicalTrials.gov