Early 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 are aged 18 to 70 years old, of any gender, and are able to agree in writing to take part and follow the trial schedule
• People who have been diagnosed with liver cancer (specifically hepatocellular carcinoma) according to 2024 Chinese guidelines, and whose tumor tests positive for a protein called GPC3 on a lab test of tumor tissue
• People whose liver cancer is at an advanced or intermediate stage (BCLC Stage B or C) that cannot be removed by surgery, has come back, or has spread — including those whose cancer progressed after surgery or local treatment, or who were not suitable for those treatments
• People whose cancer has stopped responding to at least one previous treatment, and who have previously been treated with certain types of medicines known as PD-1/L1 drugs and/or targeted therapy drugs called TKIs
• People whose liver is still functioning at a certain level (Child-Pugh A, or Child-Pugh B with a score of exactly 7), with no history of a condition where the liver causes confusion or brain problems (hepatic encephalopathy)
• People who are generally well enough to carry out light daily activities (measured by a score of 0 or 1 on a standard activity scale called ECOG)
• People who are expected to live for at least 12 weeks
• People who have at least one tumor that can be measured using standard imaging methods (CT or MRI scans)
• People who can provide either a recent tumor tissue sample or a stored tissue sample taken within the last 2 years
• People whose blood counts, liver function, kidney function, and blood clotting results meet specific laboratory levels set by the trial
• People who are able and willing to use effective contraception from the time of signing consent until one year after the last treatment; women who could become pregnant must have a negative pregnancy blood test at the start of the trial

Who may not be able to join:

• People whose cancer has spread to the brain or the lining around the brain
• People who have previously had a bone marrow or organ transplant (including a liver transplant), or who are on a waiting list for one
• People who have had another type of cancer in the past or currently, with some exceptions for certain treated skin cancers, cervical pre-cancers, or prostate cancer that has been fully treated (confirm with trial site)
• People with active hepatitis B at certain virus levels in the blood; people with active hepatitis C; people who test positive for HIV; or people who test positive for syphilis (some hepatitis B cases may still be eligible if antiviral treatment requirements are met — confirm with trial site)
• People who test positive for certain immune markers called HLA antibodies, unless the specific antibodies do not match the treatment product being used (confirm with trial site)
• People who have previously been treated with other cell-based therapies or with any treatment that specifically targeted the GPC3 protein
• People who have received certain cancer treatments too recently before joining — including chemotherapy, targeted therapy drugs, biological treatments, radiation therapy, traditional Chinese herbal medicines with anti-cancer purposes, or local treatments, within timeframes ranging from 14 to 28 days depending on the type (confirm with trial site for specific details)
• People who still have side effects from previous cancer treatment that have not returned to a mild or baseline level, apart from hair loss, mild nerve side effects, or a thyroid condition managed with hormone replacement
• People who have received a live vaccine within 28 days before signing consent, or who would need one during the trial
• People who have had major surgery within 28 days before signing consent, or who would need major surgery during the trial
• People who need ongoing use of steroid medicines (at doses of 10 mg/day of prednisone or equivalent or higher) or other medicines that suppress the immune system, unless used as an inhaler or on the skin
• People who have had an active fungal, bacterial, viral, tuberculosis, or other infection requiring treatment within 14 days before signing consent
• People who have an active or previously diagnosed autoimmune disease that could come back, such as lupus, rheumatoid arthritis, inflammatory bowel disease, psoriasis, or similar conditions
• People who have or have had a lung condition such as interstitial lung disease, a type of lung inflammation, or severely reduced lung function
• People with uncontrolled fluid build-up in the chest or abdomen (such as pleural effusion or ascites) that cannot be managed with drainage or other methods
• People with serious heart or blood vessel problems, including dangerous heart rhythm problems, a significantly prolonged heart electrical signal (QTcF), a recent heart attack, heart failure, stroke, aortic tear, or uncontrolled high blood pressure (confirm with trial site for specific values)
• People with a history of a blood clot in the lungs (pulmonary embolism) or serious leg vein clots that required a filter device or ongoing high-dose blood thinners
• People whose liver tumour takes up more than half the liver, or where the tumour has grown into major blood vessels causing complications such as high pressure in the portal vein system
• People who are already taking part in another interventional clinical trial
• People who are pregnant or breastfeeding
• People who the trial doctor believes have other conditions that would make participation unsafe or difficult

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