Phase 2 Liver Cancer Trial, Recruiting NCT04472767 Sponsor: University of California, Irvine Condition: Liver Cancer
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Phase 2 Liver Cancer Trial, Recruiting

NCT04472767
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with hepatocellular carcinoma (a type of liver cancer) based on tissue testing or imaging scans
  • People who have at least one liver tumour that can be treated with a procedure called TACE (a targeted treatment delivered directly to the tumour through blood vessels)
  • People whose liver function falls within a specific range known as Child-Pugh A or B7 (a scoring system used to assess liver health)
  • People who are not suitable for surgery to remove the tumour or for a liver transplant
  • People aged 18 or older
  • People who are well enough to carry out basic daily activities (based on a standard medical scale called ECOG, with a score of 2 or below)
  • People who have at least one tumour that can be measured on scans — either untreated or one that has grown back after a previous local treatment
  • People whose blood test results show their organs (including liver, kidneys, and bone marrow) are functioning well enough, based on specific laboratory values (confirm with trial site)
  • People who are able to use effective contraception during the trial and for several months after treatment ends, as the study drugs may harm an unborn baby (the required duration varies by drug — confirm with trial site)
  • People with a life expectancy of more than 3 months
  • People who are able to swallow tablets
  • People who are willing and able to read and sign a consent form agreeing to participate

Who may not be able to join:

  • People who have previously received any type of systemic (whole-body) anti-cancer treatment
  • People who still have significant side effects from a previous cancer treatment (other than hair loss), which have not returned to a mild or baseline level
  • People who have had any local liver treatment within the past 3 months
  • People who have a specific type of blood clot in the main vein supplying the liver (called Vp3 or Vp4 portal vein thrombus)
  • People whose cancer has spread outside the liver
  • People who are currently taking part in another clinical trial with an investigational treatment
  • People who have had a serious allergic reaction to nivolumab, cabozantinib, or similar medications used in this study
  • People taking certain blood-thinning medications, including warfarin, dabigatran, rivaroxaban, or clopidogrel (some low-dose or low molecular weight heparin options may be allowed — confirm with trial site)
  • People whose blood clotting test results are above a certain level within 28 days before the first dose (confirm with trial site)
  • People with serious uncontrolled health conditions, including active infection, heart failure, blood pressure that remains too high despite treatment, a stroke or heart attack within the past 6 months, unstable chest pain, irregular heart rhythm, or certain digestive tract problems such as bowel perforation, active ulcers, or inflammation of the bowel
  • People who have had significant bleeding (such as coughing or vomiting blood) within the past 12 weeks
  • People with certain lung lesions or tumours growing into major blood vessels outside the liver
  • People with serious unhealed wounds, uncontrolled thyroid problems, or moderate to severe liver disease (Child-Pugh B or C)
  • People with mental health or personal circumstances that would make it difficult to follow the trial requirements
  • People who have had major surgery within 2 weeks, or minor surgery within 10 days, before the first dose, or who have not fully healed from a previous surgery
  • People who have previously been treated with cabozantinib
  • People whose heart electrical activity (measured by an ECG) shows a specific abnormality called a prolonged QTcF interval above 500 ms within 28 days before the first dose
  • People who have taken a type of cancer medication called a small molecule kinase inhibitor within 2 weeks before the first dose
  • People who have had another primary cancer within the past 3 years, with some exceptions such as certain skin cancers, early-stage prostate cancer, or cervical cancer in an early stage that was treated without systemic therapy
  • People who are pregnant or breastfeeding
  • People who have a specific rare subtype of liver cancer called fibrolamellar HCC
  • People who have received any systemic anti-cancer therapy, including experimental treatments, within 4 weeks before joining the trial
  • People who have had radiation therapy within 2 to 4 weeks before the first dose (the timeframe depends on the type of radiation — confirm with trial site), or treatment with radioactive substances within 6 weeks
  • People who have received a live vaccine within 30 days before the first dose (certain inactivated flu vaccines may be allowed — confirm with trial site)
  • People who have an immune system condition, or who are taking high-dose steroid or immunosuppressant medications within 7 days before the first dose (replacement hormone therapies for certain conditions may be allowed — confirm with trial site)
  • People who have had a severe allergic reaction (Grade 3 or higher) to nivolumab or cabozantinib
  • People who have an active autoimmune disease that has required systemic medical treatment in the past 2 years (hormone replacement therapies for certain conditions are generally not considered systemic treatment — confirm with trial site)
  • People who have a history of lung inflammation (pneumonitis) that required steroid treatment, or who currently have pneumonitis
  • People who have an active infection requiring systemic treatment
  • People with a known history of HIV infection
  • People with a known history of active tuberculosis (TB)
  • People with any other condition, treatment history, or lab result that the treating doctor believes would make trial participation unsafe or unsuitable

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Farshid Dayyani, MD, PhD, Chao Family Comprehensive Cancer Center

Phone: 1-877-827-7883

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
University of California, Irvine
Registry
ClinicalTrials.gov
Start date
7 August 2020
Est. completion
1 October 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Percentage of Participants with Progression-free Survival at 6 Months; Complete Response Rate

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov