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 who have voluntarily agreed to take part and have signed a consent form.
• Adults aged 18 or older, of any gender.
• People who have been diagnosed with hepatocellular carcinoma (a type of liver cancer) confirmed by tissue or cell testing, or by clinical diagnosis.
• People whose liver cancer is classified as BCLC stage B or C, and whose cancer is not suitable for curative surgery or local treatments, or whose cancer has come back or progressed after those treatments.
• People who have completed local treatments (such as surgery, radiation, chemoembolization, radiofrequency ablation, or similar procedures) at least 4 weeks before the baseline scan (or at least 2 weeks for palliative radiotherapy).
• People who have not yet received any systemic (whole-body) treatment for their liver cancer.
• People who have at least one tumour that can be measured on a CT or MRI scan according to standard criteria, and that has not previously been treated with radiation or freezing.
• People whose liver function is rated as Child-Pugh Grade A or a better Grade B (score of 7 points or less).
• People with a general health performance score of 0, 1, or 2 on the ECOG scale (confirm with trial site).
• People whose expected survival is at least 12 weeks.
• People whose blood counts, kidney function, liver enzymes, and other key organ measurements fall within the ranges required by the trial (tested within 7 days before starting treatment) — specific thresholds apply, so the trial site can confirm.
• People with active hepatitis B who are already on, or willing to start and continue, antiviral treatment throughout the trial; people with active hepatitis C who are receiving antiviral treatment in line with standard guidelines.
• Women of childbearing potential who have a negative pregnancy test within 7 days before enrolling, are not breastfeeding, and agree to use contraception during the trial and for 6 months afterward; men who agree to use contraception during the trial and for 6 months afterward.

Who may not be able to join:

• People whose liver cancer is a specific less common type, such as cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma, or fibrolamellar carcinoma.
• People who have had another active cancer within the past 5 years, or who currently have another cancer (certain successfully treated skin cancers and other localised cancers that are considered fully resolved may still be eligible — confirm with trial site).
• People who are planning to have, or who have previously had, an organ transplant or a stem cell transplant from a donor.
• People with moderate to severe fluid build-up in the abdomen requiring drainage, or uncontrolled fluid around the lungs or heart.
• People who have had a gastrointestinal bleed in the past 6 months, or who have conditions that put them at high risk of bleeding in the digestive tract, such as serious varicose veins in the oesophagus or stomach, active ulcers, or persistently positive stool blood tests.
• People who have had a hole or abscess in the abdomen, or an abdominal fistula, in the past 6 months.
• People with known inherited or acquired bleeding or clotting disorders.
• People who are currently using, or have used within the 10 days before starting treatment, high-dose aspirin (more than 325 mg/day) or certain other blood-thinning medications such as clopidogrel, ticlopidine, dipyridamole, or cilostazol.
• People who have had a blood clot or stroke event (including mini-stroke, brain bleed, brain infarction, or pulmonary embolism) within the past 6 months.
• People with uncontrolled heart conditions, including heart failure (NYHA class II or above), unstable angina, a heart attack in the past year, significant irregular heart rhythms requiring treatment, or high blood pressure assessed as high risk by a doctor in the context of this trial.
• People with high blood pressure that cannot be well controlled with medication (systolic 140 mmHg or higher, or diastolic 90 mmHg or higher), or a history of hypertensive crises or hypertensive brain injury.
• People who have had a major blood vessel problem (such as an aortic aneurysm or arterial blood clot) within the past 6 months.
• People with serious wounds that are not healing, active ulcers, or untreated bone fractures.
• People who have had major surgery within the 4 weeks before starting treatment, or who are expected to need major surgery during the trial.
• People who are unable to swallow tablets, or who have a condition that affects the absorption of medicines in the digestive system.
• People who have had a bowel obstruction, or signs of one, within the past 6 months.
• People with unexplained gas build-up in the abdomen that is not related to a recent procedure or surgery.
• People who have had cancer spread to the brain or central nervous system, at any time.
• People with a history of hepatic encephalopathy (a condition where liver disease affects brain function).
• People with current or past lung inflammation conditions (such as interstitial lung disease, pulmonary fibrosis, or similar), or active tuberculosis.
• People with active autoimmune diseases, or a history of autoimmune conditions that may return — certain controlled conditions such as hypothyroidism managed with hormone replacement, type 1 diabetes managed with insulin, or resolved childhood asthma may still be eligible (confirm with trial site).
• People who have used immune-suppressing medications or steroid therapy (above a low dose threshold) within 14 days before starting treatment.
• People who have had a serious infection within the 4 weeks before starting treatment, or who have been taking oral or intravenous antibiotics to treat an infection within the 2 weeks before starting (people taking antibiotics for prevention only may still be eligible — confirm with trial site).
• People with a congenital or acquired immune deficiency condition, such as HIV infection.
• People who have both hepatitis B and hepatitis C infections at the same time.
• People who have previously been treated with a PD-1 or PD-L1 immunotherapy, or with the drug apatinib.
• People who have received a live vaccine within 28 days before starting treatment, or who expect to need one during or shortly after the trial.
• People who have taken part in another clinical drug trial within 28 days before starting this one.
• People who, in the judgement of the treating doctor, have other circumstances that could affect the safety or results of the trial, such as alcohol or substance use issues, serious psychiatric conditions, or significant social or family factors affecting safety.

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