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

NCT04430985 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2021-10-27

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Danish Cancer Society

    collaborator OTHER

  • Dorte Nielsen

    lead OTHER

Principal Investigators

  • Ole Larsen, MD, PhD · Herlev Hospital, Department of Oncology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-30
Primary Completion
2021-09-06
Completion
2021-09-06

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04430985 on ClinicalTrials.gov