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.

Phase 2

• Conditions: Liver Metastasis Colon Cancer
• Interventions: Drug: oxaliplatin; Drug: FOLFIRI Protocol; Drug: Bevacizumab

• Registration Number: NCT04003792
• Lead Sponsor: Rabin Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-27
• Study First Submitted QC: 2019-06-28
• Study First Posted: 2019-07-01
• Study Start: 2020-01-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-16
• Last Update Posted: 2020-10-20
• Primary Completion: 2022-01
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm prospective trial	oxaliplatin	-
single arm prospective trial	FOLFIRI Protocol	-
single arm prospective trial	Bevacizumab	-

Primary Outcome Measures

Name	Time	Method
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.	2 years

Trial Locations

Locations (1)

Rabin Medical Center; 🇮🇱 Petach Tikva, Israel