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

Sponsor
Dorte Nielsen
Study ID
NCT04430985
Phase
PHASE2
Status
Withdrawn

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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%.

Key Dates

Start date
Sep 30, 2020
Status verified
Oct 2021
Primary completion
Sep 6, 2021
Completion
Sep 6, 2021

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: FOLFOX + Immunotherapy
    8 cycles of FOLFOX every 2 weeks with intrahepatic administration of oxaliplatin in cycles 1-4, thereafter (cycles 5-8) oxaliplatin i given i.v.; starting from cycle 3 this is combined with i.v. administration of nivolumab (cycle 3-8) and ipilimumab (cycle 3 + 6) Immunotherapy: Starting from cycle 3: Nivolumab 3 mg/kg i.v. on day 3 (every 2nd week, total of 6 administrations), Ipilimumab 1 mg/kg i.v. on day 3 (every 6th week, total of 2 administrations)

Primary Outcome Measure

Disease-free Survival at 3 years [ Time Frame: 3 years from start of treatment within the trial ]

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