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.

Liver Metastasis Colon Cancer Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04003792
• Other study ID #: 0275-19-RMC
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2020
• Est. completion date: January 2022

Study information

• Verified date: October 2020
• Source: Rabin Medical Center
• Contact: Eran Sadot, MD
• Phone: +972-3-9376201
• Email: eransadot[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 49
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Metastasis Colon Cancer
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

Drug:
• oxaliplatin
intra-arterial oxaliplatin administration
• FOLFIRI Protocol
systemic FOLFIRI chemotherapy
• Bevacizumab
systemic bevacuzimab therapy

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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