Study on mFOLFIRINOX and Liver-Directed Chemotherapy for Unremovable Liver-Dominant Intrahepatic Cholangiocarcinoma

Sponsor: OHSU Knight Cancer Institute

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04251715

Provider View

This clinical trial is testing a combination of chemotherapy treatments, including mFOLFIRINOX and liver-directed floxuridine-dexamethasone, to see if they can effectively treat liver-dominant intrahepatic cholangiocarcinoma that cannot be removed by surgery.

Patient Parameters

Program Overview

The study aims to evaluate the safety and effectiveness of a treatment plan for patients with liver-dominant intrahepatic cholangiocarcinoma (ICC) that cannot be surgically removed. The treatment involves starting with a chemotherapy regimen called mFOLFIRINOX, followed by a targeted liver treatment using floxuridine and dexamethasone delivered directly to the liver through a special pump. This approach aims to control the cancer while minimizing side effects.

Description

This study is designed to test a two-part treatment plan for patients with liver-dominant intrahepatic cholangiocarcinoma (ICC) that cannot be removed by surgery. The first part involves a chemotherapy regimen called mFOLFIRINOX, which includes drugs like oxaliplatin, irinotecan, fluorouracil, and folinic acid. This is given every two weeks for eight weeks. After this initial treatment, patients will be evaluated to see if the cancer is under control.

If the cancer is stable, patients will move to the second part of the treatment, which involves a procedure to place a pump that delivers chemotherapy directly to the liver. This liver-directed treatment uses floxuridine and dexamethasone, along with another chemotherapy regimen called mFOLFIRI. Patients will receive this treatment and be monitored through imaging tests to assess how well the cancer is responding.

The study will also look at the safety of the treatment, how well patients tolerate it, and its impact on their quality of life. Researchers will collect information on tumor response, survival rates, and any complications that arise during the treatment process. Participants will complete quality of life questionnaires at various points during the study to help assess the treatment's impact on their well-being.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with intrahepatic cholangiocarcinoma (ICC) that cannot be surgically removed.
  • Cancer must be primarily in the liver and not cover more than 70% of the liver.
  • Limited spread of cancer outside the liver is allowed, such as to nearby lymph nodes or lungs.
  • Cancer must be measurable by imaging tests.
  • Patients should not have received prior treatment for ICC, but those who have had certain chemotherapy treatments may be eligible.
  • Must be in good overall health with an ECOG performance status of 0 or 1.
  • Must have adequate blood cell counts and organ function.
  • Women and men must agree to use effective contraception during the study.
  • Must be able to understand and sign informed consent and comply with study visits.

Exclusion Criteria

  • Extensive spread of cancer outside the liver or to the peritoneum.
  • Previous treatment with floxuridine, oxaliplatin, or irinotecan.
  • Previous liver-directed chemotherapy.
  • Allergic reactions to implanted devices.
  • Body size too small for the pump.
  • Certain liver conditions like sclerosing cholangitis or hepatic encephalopathy.
  • Evidence of portal hypertension or high liver pressures.
  • History of multiple abdominal surgeries.
  • Active infections or current bile duct blockages.
  • Abnormal liver artery anatomy.
  • Severe nerve damage or allergies to contrast dye.
  • Uncontrolled bleeding disorders.
  • Pregnant or breastfeeding women.
  • History of other cancers within the last 5 years, except for certain low-risk cancers.
  • Life expectancy of 12 weeks or less.
  • Inability to comply with study procedures or follow-up.
  • Emotional or psychiatric issues that prevent participation.
  • For the second treatment phase, evidence of cancer spread outside the liver.

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