Overview

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 Ino

Status:
Recruiting
Trial end date:
2022-01-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Rabin Medical Center
Treatments:
Bevacizumab
Oxaliplatin
Criteria
Subject Inclusion Criteria:

- Histologically confirmed colorectal adenocarcinoma metastatic to the liver.

- The patient must have inoperable liver metastases as agreed upon by any two
hepatobiliary surgeons and the assigned radiologist.

- A patient may have had prior chemotherapy or be previously untreated.

- ECOG PS <2

Subject Exclusion Criteria:

- Prior radiation, hepatic thermo ablation or resection (other than biopsy) to the
liver.

- Patient may not have received prior treatment with hepatic artery infusion (HAI).

- Extrahepatic metastases

- Female patients who are pregnant or lactating