Phase 3 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, of any gender
• People who have been diagnosed with primary liver cancer (hepatocellular carcinoma) that is classified as BCLC stage C (an advanced stage)
• People whose liver function is rated as Child-Pugh Grade A or B (these are measures of how well the liver is working)
• People who have not previously received first-line liver cancer drug treatments such as Sorafenib
• People who have at least one tumour that can be measured on a CT or MRI scan, and that has not already been treated with radiation, freezing, or other local procedures
• People with an ECOG performance score of 0 to 2, meaning they are able to carry out at least some daily activities (confirm with trial site)
• People whose doctors expect them to survive for at least 12 weeks
• People whose blood counts and organ function results fall within acceptable ranges, including white blood cell count, platelet count, haemoglobin level, kidney function, liver enzyme levels, and bilirubin levels
• People with hepatitis B or hepatitis C infection who are already receiving antiviral treatment that does not include interferon
• Women of childbearing age who agree to use contraception during the trial and for six months after it ends, who have a negative pregnancy test within 7 days before joining, and who are not breastfeeding; and men who agree to use contraception during the trial and for six months after it ends
• People who are willing to take part voluntarily, sign a consent form, and attend follow-up appointments as required

Who may not be able to join:

• People who have previously received immunotherapy drugs or interferon treatment
• People who have had a severe allergic reaction to monoclonal antibodies, immunotherapy, or chemotherapy drugs
• Women who are pregnant or breastfeeding
• People with a condition that weakens the immune system, whether present from birth or developed later in life
• People with abnormal blood clotting results (INR above 2.0 or PT above 16 seconds), a significant tendency to bleed, or who are currently receiving clot-dissolving or blood-thinning treatments (low-dose aspirin and low-molecular-weight heparin used as a preventive measure may be acceptable — confirm with trial site)
• People who currently have or have previously had another type of cancer, except for certain fully treated skin cancers or early-stage cervical cancer
• People who have an active infection or unexplained fever within the 7 days before joining
• People with clinically significant fluid build-up in the abdomen that requires drainage, uncontrolled fluid around the lungs, or fluid around the heart
• People who have had gastrointestinal bleeding within the 6 months before the trial starts, or who have a clear risk of gastrointestinal bleeding, such as severe varicose veins in the oesophagus or stomach, active ulcers, or persistently positive stool blood tests
• People who have had a hole in the bowel, an abdominal fistula (an abnormal internal connection), or an abscess in the abdomen within the 6 months before the trial starts
• People who have had a blood clot, stroke, mini-stroke, brain bleed, or pulmonary embolism within the 6 months before the trial starts
• People who have had a major blood vessel problem requiring surgery, or serious unhealed wounds, active ulcers, or untreated bone fractures within the 6 months before the trial starts
• People who have cancer that has spread to the brain or spinal cord, either currently or in the past
• People with a history of unresolved substance abuse involving psychiatric medications, those with a mental disorder, or those with brain metastases or a condition called hepatic encephalopathy (brain problems caused by liver disease)
• People whom the trial doctor believes may have other conditions or circumstances — such as serious illness, severe abnormal test results, or significant personal or social factors — that could affect their safety or the reliability of the trial results

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