A Comparison of mXELIRI Regimen and FOLFIRI Combined Bevacizumab Regimen as First-line Chemotherapy Regimen for Metastatic Colorectal Cancer

NCT04247984 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2022-03-11

No results posted yet for this study

Summary

This is a Phase II, multicenter,randomized, two arms, open-labeled, controlled clinical trial. This trial was conducted to evaluate the efficacy and safety of bevacizumab (Avastin®) plus mXELIRI compared with bevacizumab (Avastin®) plus FOLFIRI as first-line treatment in patients with metastatic colorectal cancer (mCRC).

Conditions

Interventions

BIOLOGICAL

Bevacizumab

5 mg/kg intravenously administered on day 1 of a 2-week cycle.

DRUG

Capecitabine

2000mg/m2/day oral on day 1 to day 10 of a 2-week cycle.

DRUG

Irinotecan

180 mg/m2 intravenously administered on day 1 of a 2-week cycle.

DRUG

5-FU

400 mg/m2 intravenous bolus on day 1 and 2400 mg/m2 continuous infusion over 44 hours of a 2-week cycle.

DRUG

CF

300 mg/m2 intravenously administered on day 1 of a 2-week cycle.

DRUG

Irinotecan

150 mg/m2 intravenously administered on day 1 of a 2-week cycle.

Sponsors & Collaborators

  • Beijing Hospital

    collaborator OTHER_GOV
  • Henan Cancer Hospital

    collaborator OTHER_GOV
  • Liaoning Cancer Hospital & Institute

    collaborator OTHER
  • Jiangsu Cancer Institute & Hospital

    collaborator OTHER
  • Chinese Academy of Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2021-04-01
Completion
2022-01-31

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT04247984 on ClinicalTrials.gov