RecruitingPhase 3NCT02102789

A Study of Systemic Chemotherapy With/Without HAI in Patients With Initially Unresectable Colorectal Liver Metastasis

Systemic Chemotherapy With or Without Hepatic Arterial Infusion With Floxuridine in Patients With Initially Unresectable Colorectal Liver Metastasis: A Prospective, Randomised, Controlled Study


Sponsor

Yuhong Li

Enrollment

142 participants

Start Date

Mar 1, 2014

Study Type

INTERVENTIONAL

Conditions

Summary

The primary objective of this study is to determine whether systemic chemotherapy combined with hepatic arterial infusion with floxuridine and dexamethasone can increase the complete resection rate (R0) and improve the overall survival in patients with initially unresectable colorectal liver metastasis.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether adding a specialized treatment directly to the liver's blood supply (called Hepatic Arterial Infusion, or HAI) — in addition to standard chemotherapy given through the bloodstream — can help shrink liver tumors caused by colorectal cancer that have spread to the liver and cannot currently be removed with surgery. **You may be eligible if...** - You are 18 to 70 years old - You have colorectal cancer that has spread to the liver only (no spread to other organs) - A team of doctors has confirmed the liver tumors cannot currently be surgically removed - You have not previously received any treatment for the liver metastases - Your blood counts, liver, and kidney function are at acceptable levels **You may NOT be eligible if...** - The cancer has spread outside the liver - You have severe circulation problems, fluid build-up in the abdomen (ascites), or clotting disorders - You have uncontrolled high blood pressure or serious heart, lung, kidney, or gastrointestinal problems - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGmFOLFOX6

Patients will receive mFOLFOX6 every 28 days: Oxaliplatin 85 mg/m2 IV over 3 hours on Day 1, 15; Leucovorin (l-LV) 200mg/m2 IV over 2 hours on Day 1, 15; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion on Day 1, 15.

DRUGHAI

Patients will receive HAI every 28 days: 0.12 mg/kg/day floxuridine (FUDR) and 25 mg dexamethasone in normal saline to a total volume of 300 ml will be administered through the HAI pump. This will be repeated on Day 1 of each 28 day cycle. FUDR administration will be a 14-day continuous infusion using the HAI pump.


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT02102789


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