NCT04430985

FOLFOX + Immunotherapy With Intrahepatic Oxaliplatin for Patients With Metastatic Colorectal Cancer

FOLFOX + Immunotherapy With Intrahepatic Administration of Oxaliplatin for Patients With Multiple Non-resectable Liver Metastasis From Colorectal Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Dorte Nielsen · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

In this trial chemotherapy regimen FOLFOX with intrahepatic administration of oxaliplatin is combined with immunotherapy (nivolumab and ipilimumab) for the group of patients with multiple liver metastasis from colorectal cancer. Investigators hope to increase the disease-free survival after 3 years from 10 % to 30%.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Oxaliplatin	Day 1 in cycle 1-4: 100 mg/m2 intrahepatic administration Day 1 in cycle 5-8: oxaliplatin 85 mg/m2 i.v.
DRUG	5-Fluorouracil	Day 1 each cycle: 400 mg/m2 i.v. bolus, 2400 mg/m2 i.v.over 46 hrs
DRUG	Leucovorin	Day 1 each cycle: 400 mg/m2 i.v.
DRUG	Nivolumab	Day 3 in cycle 3 to 8: 3 mg/kg i.v.
DEVICE	Ipilimumab	Day 3 in cycle 3 and 6: 1 mg/kg i.v.

Timeline

• Start date: 2020-09-30
• Primary completion: 2021-09-06
• Completion: 2021-09-06
• First posted: 2020-06-16
• Last updated: 2021-10-27

Locations

1 site across 1 country: Denmark