Phase 1 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 liver cancer (hepatocellular carcinoma) confirmed by a tissue or cell sample, but not the fibrolamellar, sarcomatoid, or mixed liver-bile duct cancer types
• People whose liver cancer tumour tests positive for a protein called GPC3, detected through a laboratory staining test
• People whose liver cancer has stopped responding to standard treatments, including at least one immunotherapy drug and one targeted therapy drug
• People who have at least one tumour that can be measured on a scan, according to standard medical measurement guidelines
• People whose liver cancer is classified as stage B or C using the Barcelona liver cancer staging system
• People whose liver function scores at or below 6 on the Child-Pugh scoring system, indicating relatively preserved liver function
• People whose general physical health and ability to carry out daily activities scores at 0 or 1 on the ECOG scale (meaning fully active or able to carry out light work)
• People whose blood counts, liver function, kidney function, and heart function meet specific minimum standards as measured by laboratory tests (confirm with trial site for exact values)
• People aged 18 or older
• People who are able to communicate with the research team, understand the study requirements, and sign a consent form

Who may not be able to join:

• People with active cancer spread to the brain, or brain metastases that were treated less than 4 weeks ago
• People who received an immunotherapy (checkpoint inhibitor) drug within the past 4 weeks
• People who received any experimental drug as part of another trial within the past 4 weeks
• People who received local liver cancer treatments — such as chemoembolisation (TACE), infusion chemotherapy (HAIC), Y-90 radioembolisation, ablation, or targeted radiation — within the past 4 weeks
• People who received other anti-cancer targeted therapies (such as multi-targeted TKIs or anti-VEGF drugs) within the past 3 weeks
• People who received immune-modulating treatments such as interleukins or interferons within the past 2 weeks
• People who received herbal or traditional Chinese medicine for cancer treatment within the past week
• People who previously received an experimental treatment targeting the GPC3 protein, unless their tumour still tests positive for GPC3
• People who have had a liver transplant or a blood stem cell transplant at any point
• People who still have significant side effects (above grade 1) from previous cancer treatments that have not resolved
• People who had major surgery (other than a biopsy) within the past 28 days
• People with poorly controlled high blood pressure (blood pressure at or above 160/90 mmHg)
• People who have had serious heart problems — such as severe heart failure, unstable chest pain, a heart attack, heart bypass surgery, a stent placed, a stroke, or significant heart valve disease — within the past 6 months
• People with a specific heart rhythm measurement (QTcF interval) that is too long — 450 milliseconds or more for men, or 470 milliseconds or more for women
• People who had a serious infection within the past 4 weeks, have signs of an active infection within the past 2 weeks, needed antibiotic treatment within the past 2 weeks, or have an unexplained fever above 38.5°C
• People with hepatitis B who have not been on antiviral treatment for at least 2 weeks, or whose hepatitis B virus levels in the blood remain high (confirm with trial site for exact values)
• People with hepatitis C who have not completed at least 4 weeks of antiviral treatment
• People who are HIV positive
• People who need to take corticosteroid medicines (at a dose equivalent to more than 10 mg of prednisone per day) or other immune-suppressing drugs
• People who have been treated for an autoimmune disease (a condition where the immune system attacks the body) within the past 2 years
• People who have had another type of cancer within the past 2 years, with some exceptions for certain low-risk, fully treated cancers (confirm with trial site)
• People who are pregnant or breastfeeding
• People whom the trial doctor believes, for any other reason, are not suitable for the study

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