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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.

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.

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04003792
Enrollment
49
Registered
2019-07-01
Start date
2020-01-01
Completion date
2022-01-31
Last updated
2020-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Metastasis Colon Cancer

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.

Interventions

DRUGoxaliplatin

intra-arterial oxaliplatin administration

systemic FOLFIRI chemotherapy

DRUGBevacizumab

systemic bevacuzimab therapy

Sponsors

Rabin Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
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

Countries

Israel

Contacts

Primary ContactEran Sadot, MD
eransadot@gmail.com+972-3-9376201

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026