Trial snapshot
- Formal name: A Phase I/II Study of Nivolumab Plus 5-Fluorouracil Plus Interferon-α2b for Unresectable Fibrolamellar Hepatocellular Carcinoma
- Trial type: Specifically designed for fibrolamellar carcinoma
- Phase: Phase I/II
- Recruitment status: Active, recruiting
- Eligible ages: 12 years and older
- Locations: Houston, TX (M.D. Anderson Cancer Center)
- ClinicalTrials.gov ID: NCT04380545
Overview
This phase I/II trial, launched in early 2020, studies the side effects and how well the combination of nivolumab, fluorouracil, and interferon alpha-2b works for the treatment of fibrolamellar carcinoma (FLC) that cannot be removed by surgery. Immunotherapy with checkpoint inhibitors, 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. Treatment with a combination of nivolumab, fluorouracil, and interferon alpha-2b may work better in treating unresectable fibrolamellar cancer compared to treatment with fluorouracil and interferon alpha-2b alone. This clinical trial stages the drug administration and includes the analysis of “before and after” patient biopsies (samples of tumor tissue) to better understand how the drug combination may affect patients’ immune responses to FLC.
Trial details:
Enrollment in this trial is open to FLC patients 12 years old and older. The study’s principal investigator is Dr. Sunyoung Lee at University of Texas M.D. Anderson Cancer Center. Dr. Ahmed Kaseb at M.D. Anderson Cancer Center is the co-investigator. Additional details can be found at: https://www.clinicaltrials.gov/study/NCT04380545.
Dr. Ahmed Kaseb, an investigator for this study, discusses the design, eligibility criteria and rationale for this trial in the video below:
Please visit clinicaltrials.gov for a comprehensive list of active trials.
The Fibrolamellar Cancer Foundation does not provide medical advice. We provide website users with information to help them better understand their health conditions and current approaches towards diagnosis, treatment and supportive care. Always seek the advice of your physician or other qualified healthcare provider.