OncoMatch/Clinical Trials/NCT04380545
Nivolumab, Fluorouracil, and Interferon Alpha 2B for the Treatment of Unresectable Fibrolamellar Cancer
Is NCT04380545 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Nivolumab and Recombinant Interferon Alpha 2b-like Protein for stage iii hepatocellular carcinoma ajcc v8.
Treatment: Fluorouracil · Nivolumab · Recombinant Interferon Alpha 2b-like Protein — 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 spreading. Interferon alpha 2b may help stimulate the immune system to fight cancer. Giving nivolumab, fluorouracil, and interferon alpha 2b may work better in treating unresectable fibrolamellar cancer compared to fluorouracil and interferon alpha 2b alone.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Disease stage
Required: Stage III, IIIA, IIIB, IV, IVA, IVB (AJCC v8)
Unresectable Fibrolamellar Carcinoma; measurable disease defined as a lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) and measures >= 15 mm with conventional techniques or >= 10 mm with more sensitive techniques such as MRI or spiral CT scan
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1 therapy
Exception: for FLHCC treatment
Patients must not have received prior anticancer therapy with anti-PD-1 for FLHCC treatment
Cannot have received: systemic therapy
Exception: concomitant therapy for FLHCC
Patients receiving any concomitant systemic therapy for FLHCC are excluded
Lab requirements
Blood counts
ANC >= 1,000 /mm^3; Platelets >= 100,000 /mm^3; Hemoglobin > 9.0 g/dL (may be transfused or receive epoetin alfa to maintain or exceed this level)
Kidney function
Serum creatinine <= 1.5x ULN or estimated creatinine clearance > 40 mL/min
Liver function
Total bilirubin <= 1.5 mg/dL; AST and/or ALT <= 5x institutional ULN; No advanced cirrhosis, with Child-Pugh A
No advanced cirrhosis, with Child-Pugh A; ANC >= 1,000 /mm^3; Platelets >= 100,000 /mm^3; Hemoglobin > 9.0 g/dL; Total bilirubin <= 1.5 mg/dL; Serum creatinine <= 1.5x ULN or estimated creatinine clearance > 40 mL/min; AST and/or ALT <= 5x institutional ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
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