Study on Nivolumab, Fluorouracil, and Interferon Alpha 2B for Treating Unremovable Fibrolamellar Liver Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT04380545

Provider View

This clinical trial is testing a combination of drugs, including nivolumab, fluorouracil, and interferon alpha 2b, to see if they can effectively treat fibrolamellar liver cancer that cannot be removed by surgery.

Patient Parameters

Program Overview

This study is exploring whether a combination of drugs—nivolumab, fluorouracil, and interferon alpha 2b—can help treat fibrolamellar liver cancer that cannot be surgically removed. Nivolumab is an immunotherapy drug that may help the immune system attack cancer cells. Fluorouracil is a chemotherapy drug that stops cancer cells from growing and spreading. Interferon alpha 2b may boost the immune system to fight cancer. The study aims to see if this combination works better than using fluorouracil and interferon alpha 2b alone.

Description

The main goal of this study is to check the safety and how well patients tolerate the combination of nivolumab, fluorouracil (5-FU), and interferon alpha 2b for treating fibrolamellar liver cancer that cannot be removed by surgery. The study will also look at how effective this treatment is in stopping the cancer from growing or spreading.

Patients will receive fluorouracil continuously through an IV on specific days and interferon alpha 2b through injections under the skin. This treatment cycle repeats every 28 days for two cycles unless the cancer worsens or side effects become too severe. Starting from the third cycle, patients will also receive nivolumab through an IV. This treatment can continue for up to two years if it remains effective and tolerable.

After finishing the treatment, patients will have follow-up visits 30 days later and then every 12 weeks for up to six years to monitor their health and any long-term effects.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate, and if under 18, must also give assent.
  • Must have confirmed fibrolamellar liver cancer that cannot be removed by surgery.
  • Must have measurable cancer that can be tracked using scans.
  • Must be in good overall health with a performance status score of 1 or less.
  • Must not have advanced liver cirrhosis.
  • Must have adequate blood cell counts and organ function as determined by specific tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after the study.
  • Men must agree to use contraception during and after the study if they have partners who can become pregnant.
  • Must not be breastfeeding.

Exclusion Criteria

  • Have another type of cancer that has not been disease-free for at least two years.
  • Have had a major surgery or injury that has not healed well within six weeks before starting the study.
  • Have autoimmune diseases like Crohn's disease or lupus.
  • Have a history of HIV or AIDS.
  • Have any medical condition that could make the study treatment unsafe.
  • Have a history of certain digestive issues or brain conditions.
  • Have had a heart attack or severe heart problems within the last year.
  • Have received live vaccines within a month before starting the study.
  • Have active hepatitis B or C infections.
  • Have a history of bleeding disorders or recent blood clots.
  • Are pregnant or breastfeeding.
  • Have had a liver transplant.
  • Are taking high doses of steroids or other immune-suppressing drugs.
  • Cannot comply with the study schedule and requirements.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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