Study on Cabozantinib Combined with Ipilimumab/Nivolumab and TACE for Liver Cancer

Sponsor: University of California, Irvine

Sponsor score: 40

ClinicalTrials ID:NCT04472767

Provider View

This clinical trial is testing a new treatment combination for liver cancer that cannot be cured with surgery or transplant. It involves using the drugs cabozantinib, ipilimumab, and nivolumab, along with a procedure called transarterial chemoembolization (TACE).

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effectiveness of a new treatment combination for patients with liver cancer (hepatocellular carcinoma) who are not eligible for surgery or transplant. The treatment includes the drugs cabozantinib, ipilimumab, and nivolumab, along with a procedure called transarterial chemoembolization (TACE). This is a phase 2 trial, meaning it is focused on determining how well the treatment works.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with liver cancer (hepatocellular carcinoma).
  • Have at least one tumor that can be treated with TACE.
  • Liver function classified as Child-Pugh A or B7.
  • Not eligible for surgery or liver transplant.
  • Aged 18 years or older.
  • General health status allowing for daily activities (ECOG score of 2 or less).
  • Have at least one measurable tumor that has not been treated or has grown after previous treatment.
  • Adequate blood and organ function, including:
    • White blood cells ≥ 2,000/mcL
    • Neutrophils ≥ 1,000/mcL
    • Platelets ≥ 60,000/mcL
    • Normal bilirubin levels
    • Liver enzymes within specified limits
    • Creatinine <1.5 times the upper limit of normal
    • Hemoglobin ≥ 8 g/dL
    • Serum albumin ≥ 2.8 g/dL
    • Urine protein/creatinine ratio ≤ 1 mg/mg
  • Women and men must agree to use effective birth control during the study and for several months after the last dose of treatment.
  • Life expectancy of more than 3 months.
  • Able to swallow tablets.
  • Able to understand and sign a consent form.

Exclusion Criteria

  • Have had any previous systemic anti-cancer treatment.
  • Have unresolved side effects from previous cancer treatments.
  • Have had any local treatment for liver cancer within the last 3 months.
  • Have certain types of blood clots in the liver.
  • Have cancer that has spread outside the liver.
  • Are taking other experimental drugs.
  • Have allergies to similar drugs used in the study.
  • Are on certain blood thinners that are not allowed.
  • Have uncontrolled health issues, such as:
    • Active infections
    • Heart failure
    • High blood pressure
    • Recent stroke or heart attack
    • Severe digestive issues
  • Have had major surgery recently.
  • Have a history of another cancer within the last 3 years, except for certain skin or prostate cancers.
  • Are pregnant or breastfeeding.
  • Have certain liver conditions or have had liver-directed treatments.
  • Have received a live vaccine recently.
  • Have an immune deficiency or are on long-term steroid treatment.
  • Have severe allergies to the study drugs.
  • Have an active autoimmune disease requiring treatment.
  • Have a history of lung inflammation requiring steroids.
  • Have an active infection needing treatment.
  • Have a history of HIV or tuberculosis.
  • Have any condition that might interfere with the study or is not in the participant's best interest.

Locations

FACILITYZIPCITYSTATE
Chao Family Comprehensive Cancer Center, University of California, Irvine92868OrangeCalifornia

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