Nivolumab, Fluorouracil, and Interferon Alpha 2B for the Treatment of Unresectable Fibrolamellar Cancer

This phase I/II trial studies the side effects and how well nivolumab, fluorouracil, and interferon alpha 2b work for the treatment of fibrolamellar cancer (liver cell cancer) that cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from sprea

Trial Details

NCT ID
NCT04380545
Phase
PHASE1 / PHASE2
Sponsor
M.D. Anderson Cancer Center
Status
RECRUITING
Cancer Type
Hepatocellular Carcinoma (HCC) Liver Cancer
Interventions
  • Fluorouracil
  • Nivolumab
  • Recombinant Interferon Alpha 2b-like Protein
Locations (sample)
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

  • Patients, or their legal guardian, must give written informed consent prior to initiation of therapy, and patients under age 18 must give assent in…
  • Patients with histologically confirmed FLHCC (or with documentation of original biopsy for diagnosis is acceptable if tumor tissue is unavailable).…
  • Patient must have measurable disease defined as a lesion that can be accurately measured in at least one dimension (longest diameter to be recorded…
  • Eastern Cooperative Oncology Group performance status (ECOG PS =\< 1), or for patients under age 18 Karnofsky performance status of \>= 70

For full eligibility, visit ClinicalTrials.gov.

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