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Anti-metabolites
Immunotherapy + Chemotherapy for Liver Cancer
Phase 1 & 2
Waitlist Available
Led By Sunyoung Lee
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with histologically confirmed FLHCC (or with documentation of original biopsy for diagnosis is acceptable if tumor tissue is unavailable). The determination of resectability status will ultimately lie in the clinical judgment of the surgical oncologist and medical oncologist involved in the care of the patient. The definition of resectability is as follows: hepatectomy can achieve a negative margin while preserving more than 30% of the total estimated liver volume, sparing two contiguous hepatic segments, and maintaining vascular inflow, vascular outflow, and biliary drainage. Patients with extrahepatic disease are defined as having unresectable disease
Eastern Cooperative Oncology Group performance status (ECOG PS =< 1), or for patients under age 18 Karnofsky performance status of >= 70
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights
Study Summary
This trial is testing a combination of immunotherapy and chemotherapy to treat patients with unresectable fibrolamellar cancer.
Who is the study for?
This trial is for patients with a specific liver cancer called unresectable fibrolamellar carcinoma. Eligible participants must have measurable disease, be in good physical condition (ECOG PS <=1 or Karnofsky >=70), and have proper organ function. They should not be pregnant, breastfeeding, or planning to conceive, and must agree to use contraception. Those with serious health issues like heart disease, uncontrolled hypertension, severe liver dysfunction, or active infections are excluded.Check my eligibility
What is being tested?
The study is testing the effectiveness of combining nivolumab (an immunotherapy drug), fluorouracil (a chemotherapy drug), and interferon alpha 2b (an immune system stimulator) for treating this type of liver cancer that can't be surgically removed. It's a phase I/II trial aiming to see how well these drugs work together compared to using just fluorouracil and interferon alpha 2b.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system attacking normal cells leading to inflammation in various organs, infusion-related reactions from the drugs being administered into the bloodstream, fatigue from treatment-induced exhaustion, digestive problems such as nausea or diarrhea due to chemotherapy impact on stomach lining and blood disorders affecting cell counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Conversion rate to surgery
Overall response rate (ORR)
Progression-free survival (PFS)
Other outcome measures
Tissue and blood immunohistochemistry
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (fluorouracil, interferon alpha 2b, nivolumab)Experimental Treatment3 Interventions
Patients receive fluorouracil IV continuously on days 1-7 and 15-21 and recombinant interferon alpha 2b-like protein SC on days 1, 3, 5, 15, 17, and 19. Treatment repeats every 28 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Beginning in cycle 3, patients receive nivolumab IV over 30 minutes on day 1, fluorouracil IV continuously on days 1-7 and 15-21, and recombinant interferon alpha 2b-like protein interferon alpha 2b SC on days 1, 3, 5, 15, 17, and 19. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluorouracil
2014
Completed Phase 3
~11540
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,721 Previous Clinical Trials
40,965,043 Total Patients Enrolled
2 Trials studying Fibrolamellar Carcinoma
620 Patients Enrolled for Fibrolamellar Carcinoma
M.D. Anderson Cancer CenterLead Sponsor
2,992 Previous Clinical Trials
1,792,640 Total Patients Enrolled
Sunyoung LeePrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received a live or weakened virus vaccine within the past month before starting the study.You have had cancer, except for non-melanoma skin cancer or early stage cancer that has been treated and you have been cancer-free for at least 2 years.You have had a liver transplant in the past.You have a severe wound, ulcer, or bone fracture that has not healed yet.You have had an organ transplant.You are taking strong medications that suppress your immune system, or high doses of steroids. Exceptions may be made if you experience severe side effects or allergic reactions during the trial.You cannot be dependent on total parenteral nutrition.You have a history of autoimmune diseases like rheumatoid arthritis, lupus, or inflammatory bowel disease.You have a medical condition that could make taking the study drug dangerous or difficult to understand any side effects. For example, if you have a condition that causes frequent diarrhea.You have a history of certain conditions that increase the risk of bowel perforation, such as acute diverticulitis, abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, gastrointestinal obstruction, or abdominal cancer spread.You have a type of brain tumor that is not benign, any brain tumors that have spread from other parts of your body, or any neurological conditions that are not well controlled with standard medications. Additionally, you have had a stroke within the past year.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (fluorouracil, interferon alpha 2b, nivolumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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