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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cetuximab, Leucovorin, Oxaliplatin, and Fluorouracil With or Without Bevacizumab in Treating Patients With Resectable Liver Metastases From Colorectal Cancer

NCT00438737

Colorectal Cancer Metastatic Cancer

UNKNOWN PHASE2

Hepatic Arterial Infusion With FOLFOX Alone or in Combination With IV Chemotherapy in Colon Cancer With Liver Metastasis

NCT02345746

Metastatic Colorectal Cancer

WITHDRAWN PHASE2

The Efficacy of Bevacizumab Combined With m-FOLFOXIRI in Borderline Resectable Colorectal Liver Metastases

NCT03711240

Colorectal Cancer

UNKNOWN PHASE2

Combination Chemotherapy and Bevacizumab as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer

NCT00719797

Colorectal Cancer

COMPLETED PHASE3

Adjuvant Hepatic Arterial Infusion and Combination Chemotherapy in Treating Patients With Resectable Hepatic Metastases From Colorectal Cancer

NCT00059930

Metastatic Cancer Colorectal Cancer

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Metastasis Colon Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

single arm prospective trial

Group Type EXPERIMENTAL

oxaliplatin

Intervention Type DRUG

intra-arterial oxaliplatin administration

FOLFIRI Protocol

Intervention Type DRUG

systemic FOLFIRI chemotherapy

Bevacizumab

Intervention Type DRUG

systemic bevacuzimab therapy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

oxaliplatin

intra-arterial oxaliplatin administration

Intervention Type DRUG

FOLFIRI Protocol

systemic FOLFIRI chemotherapy

Intervention Type DRUG

Bevacizumab

systemic bevacuzimab therapy

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No