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 aged 18 to 75 years.
• People with liver cancer (hepatocellular carcinoma) that has been confirmed by tissue or cell testing, or by imaging scans with mandatory tissue confirmation before joining.
• People whose liver cancer cannot be removed by surgery, has spread, or is at an advanced stage where surgery, transplant, or further local treatments are not possible or have stopped working.
• People whose cancer has gotten worse on at least one prior standard drug treatment, who could not tolerate it, or who were not eligible for it.
• People whose tumor tissue, tested at a central laboratory, shows sufficient levels of two specific proteins called GPC3 and B7-H3 (confirm with trial site for exact thresholds).
• People who have at least one measurable area of cancer that can be tracked on scans according to standard measurement guidelines.
• People who are generally well enough to carry out light activity and care for themselves, as measured by a standard medical scoring system (ECOG score of 0 or 1).
• People whose liver is functioning at an acceptable level, as assessed by a standard liver scoring system (Child-Pugh class A, or a specific stable Child-Pugh B7 score without uncontrolled fluid buildup or recent brain complications).
• People with an estimated life expectancy of at least 12 weeks.
• People whose blood counts, kidney function, liver function, and other organ markers fall within acceptable ranges as defined by the trial (confirm with trial site for specific values).
• People with hepatitis B or a history of hepatitis B exposure must have a very low virus level in the blood and must be on appropriate antiviral medication before the treatment preparation phase begins. Controlled hepatitis C may also be acceptable per trial rules.
• People who are not pregnant, as confirmed by a blood test, and who agree to use effective contraception during the trial (for those who could become pregnant).
• People who are able to understand the trial and sign a consent form.

Who may not be able to join:

• People who have previously received certain types of genetically modified cell therapies (such as CAR-T or similar treatments) within a set time period before joining, or who still have significant side effects from such treatments.
• People with active, uncontrolled infections, including bacterial, viral, or fungal infections, uncontrolled HIV, active hepatitis B or C with high virus levels, or active tuberculosis.
• People with known active cancer that has spread to the brain or the lining of the brain and spine, especially if it requires increasing steroid doses or urgent treatment.
• People who have previously had a liver transplant or any other solid organ transplant, or who currently need ongoing medication to suppress their immune system.
• People with significant fluid buildup in the abdomen requiring frequent draining, a recent episode of significant liver-related brain confusion (hepatic encephalopathy grade 2 or higher within the past 4 weeks), or recent serious bleeding from veins in the digestive tract.
• People whose liver has been very extensively replaced by tumour (for example 70% or more), or who have complete blockage of major blood vessels supplying the liver, in a way the trial doctors judge creates too high a risk.
• People who have had major surgery, local liver treatments, radiation, or systemic cancer treatment too recently before the treatment preparation phase, within timeframes set by the trial protocol.
• People with an active autoimmune disease that requires ongoing immune-suppressing medication, or who are taking high doses of steroid medications on an ongoing basis.
• People with significant heart or lung conditions, such as a recent heart attack, unstable heart rhythm, uncontrolled heart failure, or serious breathing problems, or other serious health conditions that would significantly increase the risks of participating.
• People who are pregnant or breastfeeding.
• People who have another active cancer that is growing or currently requires systemic treatment.
• People with a medical or mental health condition that, in the trial doctor's judgement, could affect their safety, their ability to follow the trial requirements, or the reliability of the trial results.

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