Treatment With Hepatic Arterial Infusion of Oxaliplatin in Combination With Systemic FOLFIRI Chemotherapy and Bevacuzimab in Patients With Liver-only Colorectal Liver Metastases (CRLM): Conversion to Complete Resection in Patients With Initially Inoperable Liver-only CRLM.

Sponsor
Rabin Medical Center
Study ID
NCT04003792
Phase
PHASE2
Status
Unknown

Conditions

  • Liver Metastasis Colon Cancer

Eligibility Criteria

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

Interventions

  • oxaliplatin — DRUG
    intra-arterial oxaliplatin administration
  • FOLFIRI Protocol — DRUG
    systemic FOLFIRI chemotherapy
  • Bevacizumab — DRUG
    systemic bevacuzimab therapy

Study Details

A few studies have documented that some patients can be down-staged from an initially inoperable state to a potentially resectable state. Five-year survival in initially inoperable patients that ultimately come to a complete resection appears to be similar to patients who are resected at first presentation. The investigators goal is to assess the rate of conversion to complete resection in patients with initially inoperable liver-only metastases due to colorectal cancer after treatment with HAI of oxaliplatin with FOLFIRI and bevacuzimab systemic treatment.

Key Dates

First listed
Jul 1, 2019
Start date
Jan 1, 2020
Status verified
Oct 2020
Primary completion
Jan 31, 2022
Completion
Jan 31, 2022

Study Design

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

Arms

  • Experimental: single arm prospective trial

Primary Outcome Measure

conversion rate to complete resection in patients with initially inoperable liver-only metastases due to colorectal cancer after treatment with HAI of oxaliplatin with FOLFIRI and bevacuzimab systemic treatment. [ Time Frame: 2 years ]

Central Contacts

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