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.
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About
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.
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Inclusion and exclusion 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
49 participants in 1 patient group
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Central trial contact
Eran Sadot, MD
Data sourced from clinicaltrials.gov
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