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

PHASE3RecruitingINTERVENTIONAL
Enrollment

142

Participants

Timeline

Start Date

March 31, 2014

Primary Completion Date

August 31, 2024

Study Completion Date

December 31, 2024

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

mFOLFOX6

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.

DRUG

HAI

"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."

Trial Locations (1)

510060

RECRUITING

Sun Yat-sen University Cancer Center, Guangzhou

All Listed Sponsors
lead

Yuhong Li

OTHER