Actively Recruiting
Nivolumab, Fluorouracil, and Interferon Alpha 2B for the Treatment of Unresectable Fibrolamellar Cancer
Led by M.D. Anderson Cancer Center · Updated on 2026-03-06
15
Participants Needed
1
Research Sites
371 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Nivolumab, Fluorouracil, and Interferon Alpha 2B for the Treatment of Unresectable Fibrolamellar Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients or their legal guardians must provide written informed consent; patients under 18 must give assent
- Histologically confirmed unresectable fibrolamellar hepatocellular carcinoma
- Measurable disease with lesion size ≥15 mm by conventional imaging or ≥10 mm by sensitive imaging
- Eastern Cooperative Oncology Group performance status ≤1, or Karnofsky performance status ≥70 if under 18
- No advanced cirrhosis; Child-Pugh class A
- Adequate blood counts and organ function within 14 days before first dose
- Women of childbearing potential must have negative pregnancy test within 24 hours of treatment start
- Women must not be breastfeeding
- Agree to use effective contraception during and after treatment as specified
- Men sexually active with women of childbearing potential must agree to contraception as specified
- Azoospermic males and women not heterosexually active are exempt from contraception but women must undergo pregnancy testing
You will not qualify if you...
- Any other malignancy within past 2 years except non-melanoma skin cancer or in situ carcinoma
- Organ transplant recipients
- Major surgery, open biopsy, or significant injury with poorly healed wounds within 6 weeks before first dose
- History of autoimmune diseases including inflammatory bowel disease, rheumatoid arthritis, lupus, or vasculitis
- Known HIV infection or AIDS
- Medical conditions that could complicate treatment or interpretation of side effects
- History of acute diverticulitis, abdominal fistula, bowel perforation, abscess, obstruction, or carcinomatosis
- Primary brain tumors (except meningiomas), brain metastases, leptomeningeal disease, uncontrolled seizures, or recent stroke
- Serious heart or vascular diseases including recent heart attack, unstable angina, uncontrolled hypertension, or heart failure
- History of coagulopathy, bleeding disorders, or thrombosis within past year
- Serious non-healing wounds, ulcers, or fractures
- Pregnant or lactating women
- Prior liver transplantation
- Cirrhosis with severe liver dysfunction (Child-Pugh B or C)
- Prior anti-PD-1 therapy for fibrolamellar hepatocellular carcinoma
- Receiving other systemic therapy for fibrolamellar hepatocellular carcinoma
- Scheduled to receive another experimental drug during study
- Need for ongoing anticoagulation except aspirin; surgical prophylaxis allowed
- Require total parenteral nutrition
- Use of high dose steroids or strong immune suppressants except for certain side effects
- Unable to comply with study visit schedule
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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