Phase 2 Liver Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with hepatoblastoma (HB), hepatocellular neoplasm not otherwise specified (HCN-NOS), or hepatocellular carcinoma (HCC), confirmed by a tissue sample, with a specific protein marker (AFP) above 100 ng/mL in their blood at the time of screening.
• People whose cancer has come back after treatment (relapse), or whose cancer did not respond to standard treatment (refractory).
• People aged 1 to 21 years old.
• People whose immune system markers (a genetic test called HLA typing) show at least one copy of a specific marker called HLA-A2.
• People whose doctor estimates they have a life expectancy of more than 4 months.
• People who have a performance score of 70 or above on the Lansky or Karnofsky scale, meaning they are able to carry out a reasonable level of daily activity (confirm with trial site).
• People who have tumours of a certain minimum size — for the dose-finding stage, at least one tumour 5mm or larger, or two or more tumours 3mm or larger; for the dose-expansion stage, measurable disease by a standard imaging measurement system (confirm with trial site).
• People with a liver function score (Child-Pugh score) of A6 or better, indicating the liver is functioning at an acceptable level.
• People whose organs (such as kidneys, liver, and blood cells) are functioning adequately as assessed by the trial team.

Who may not be able to join:

• People with returning hepatoblastoma where surgery could completely remove the cancer (for example, lung tumours that could be fully removed surgically).
• People with pre-existing serious conditions such as heart failure, uncontrolled lung disease unrelated to cancer, or a psychiatric illness or personal situation that could make it difficult to follow the study requirements.
• People with an active, uncontrolled bacterial, fungal, or viral infection. Note: People living with HIV, hepatitis B, or hepatitis C may still be considered if their infection is being treated and the virus is at a controlled level.
• People with any other known active cancer besides HB, HCN-NOS, or HCC.
• People who are pregnant or breastfeeding.
• People who have received certain cancer treatments — including chemotherapy, radiation, immunotherapy, or immunosuppressive therapy — within specific time windows before key steps in the trial process (confirm exact timeframes with trial site). This also includes people who have recently received high-dose steroid medications or a type of therapy called a T-cell engager (TCE) within certain timeframes.
• People who are currently receiving other experimental treatments, or other biological, chemical, or radiation therapies at the same time as this study.
• People for whom the specific chemotherapy drugs used in this trial (Fludarabine and Cyclophosphamide) are medically unsuitable.
• People with an active autoimmune disease that requires ongoing treatment with immune-suppressing medication.
• People with significantly reduced or blocked blood flow in the main blood vessels of the liver or a major connected vein, where the trial doctor believes this makes participation unsafe.
• People who have previously had an organ transplant.
• People whose cancer affects more than 50% of the liver by volume.

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