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%.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Day 1 in cycle 1-4: 100 mg/m2 intrahepatic administration Day 1 in cycle 5-8: oxaliplatin 85 mg/m2 i.v.
Day 1 each cycle: 400 mg/m2 i.v. bolus, 2400 mg/m2 i.v.over 46 hrs
Day 1 each cycle: 400 mg/m2 i.v.
Herlev University Hospital, Department of Oncology
Herlev, Denmark
Disease-free Survival at 3 years
Proportion of patients without signs of disease 3 years after treatment start
Time frame: 3 years from start of treatment within the trial
Patients becoming eligible for resection of liver metastasis
Number of patients with reduction of tumor burden to an extent that they become eligible for resection/radio frequency ablation of liver metastasis
Time frame: Evaluation of resectability after 8 cycles (each cycle is 14 days) of treatment (i.e after 16 weeks)
Objective response rate
Proportion of patients with complete or partial response according to RECIST v1.1
Time frame: Evaluation by CT-scan after 8 cycles (each cycle is 14 days) of treatment (i.e after 16 weeks)
Progression free survival
Time from start of treatment to progression of disease or death
Time frame: Evaluation by CT-scan after 8 cycles of treatment each cycle is 14 days) and every 3 months thereafter until progression (max 3 years)
Overall survival
Time from start of treatment to death
Time frame: Survival follow-up is planned for at least 3 years from treatment start
Safety and tolerability of the treatment
Incidence of treatment related Adverse Events
Time frame: During the 16 weeks of treatment and 100 days thereafter (up to 31 weeks)
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Day 3 in cycle 3 to 8: 3 mg/kg i.v.
Day 3 in cycle 3 and 6: 1 mg/kg i.v.