The Efficacy of Bevacizumab Combined With m-FOLFOXIRI in Borderline Resectable Colorectal Liver Metastases

Sponsor
National Cheng-Kung University Hospital
Study ID
NCT03711240
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — DRUG
    5mg/kg iv day 1 every 2 weeks
  • Oxaliplatin — DRUG
    85mg/m2 2-hour iv infusion, day 1 every 2 weeks
  • Irinotecan — DRUG
    150mg/m2 1.5-hour iv infusion, day 1 every 2 weeks
  • Leucovorin — DRUG
    200mg/m2 2-hour iv infusion, day 1 every 2 weeks
  • 5-FU — DRUG
    2400mg/m2 46-hour continuous iv infusion, day 1 every 2 weeks

Study Details

This single-arm study will evaluate the resection rate of liver metastases in patients with metastatic colorectal cancer and borderline unresectable liver metastases receiving treatment with bevacizumab in combination with modified-FOLFOXIRI as first line treatment. Patients will receive bevacizumab (5 mg/kg) plus modified-FOLFOXIRI (irinotecan 150 mg/m2, oxaliplatin 85 mg/m2, leucovorin 200 mg/m2, and fluorouracil 2400 mg/m2 as a 46-h continuous infusion) every 14 days as neoadjuvant chemotherapy regimen. This study treatment will continue until surgery, disease progression, unacceptable toxicity, or patient refusal.

Key Dates

Start date
Jan 8, 2019
Status verified
Mar 2019
Primary completion
Oct 30, 2020
Completion
Oct 30, 2020

Study Design

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

Arms

  • Experimental: bevacizumab+mFOLFOXIRI

Primary Outcome Measure

Resection rate of liver metastases [ Time Frame: 6 months ]

Central Contacts

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