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 who are willing and able to give written consent to participate.
• People who have a life expectancy of at least 3 months.
• People who are generally well enough to carry out daily activities with little or no limitation (as measured by a standard medical scale called ECOG, scored 0 or 1).
• People who have been diagnosed with hepatocellular carcinoma (a type of liver cancer), confirmed either by a tissue or cell sample, or by established medical diagnostic guidelines in people with liver scarring (cirrhosis).
• For the Phase Ib part of the trial: people whose liver cancer is at an intermediate or advanced stage (BCLC stage B or C), whose cancer has stopped responding to standard treatments, and who have received no more than two prior anti-cancer treatment courses.
• For the Phase II part of the trial: people whose liver cancer is at an advanced stage (BCLC stage C) and is not suitable for curative or local treatments, or who have intermediate-stage cancer (BCLC stage B) that could not be fully treated by curative or local approaches — and who have not previously received any systemic (whole-body) anti-cancer treatment for this liver cancer.
• People who have at least one area of cancer that can be clearly measured on scans, or a measurable area that has visibly grown after local treatment.
• People whose liver is functioning at a good level, as measured by a standard grading system called Child-Pugh Grade A.
• People whose organs (such as kidneys and bone marrow) are functioning well enough to meet the trial's requirements.
• People who are able to use effective contraception during the trial and for 120 days after the last dose of the study treatment (applies to anyone who could potentially become pregnant or father a child).
• People who are able to follow all study procedures and requirements throughout the trial.

Who may not be able to join:

• People whose liver cancer has certain specific cell types confirmed by testing, such as fibrolamellar, sarcomatoid, or bile duct (cholangiocarcinoma) components.
• People who have had another type of cancer in the past 5 years — though some exceptions may apply for certain skin cancers, superficial bladder cancer, or early-stage cervical or breast cancers that were fully treated locally (confirm with trial site).
• People whose tumour takes up more than 50% of their liver volume, or who have cancer that has spread into major blood vessels near the liver (portal vein or inferior vena cava).
• People whose tumour has grown into important nearby organs or blood vessels in a way that the trial doctor believes would cause a higher risk of serious bleeding.
• People who have cancer that has spread to the brain or spinal cord, or to the lining surrounding the brain and spinal cord.
• People who have fluid build-up around the lungs, heart, or abdomen that is causing symptoms or needs to be drained regularly.
• People who have previously received immunotherapy of any kind, including immune checkpoint inhibitors, immune checkpoint activators, immune cell therapies, or similar treatments that target the immune system's role in fighting cancer.
• People who have had local treatment to the liver within 4 weeks before the first study dose, or palliative radiation to a non-liver area within 2 weeks before the first study dose.
• People who have a history of non-infectious lung inflammation that required steroid treatment, or who currently have certain lung conditions such as interstitial lung disease, dust-related lung disease, drug-induced lung damage, or severely reduced lung function.
• People with a history of serious bleeding problems or blood-clotting disorders.
• People with a previous history of heart muscle inflammation (myocarditis), disease of the heart muscle (cardiomyopathy), or dangerous irregular heart rhythms.
• People who have had a blood clot in an artery or vein, a mini-stroke, a stroke, a severe high blood pressure crisis, or high blood pressure affecting the brain within the 6 months before the first study dose.
• People who are pregnant or breastfeeding.
• People with any other health condition, ongoing treatment, or abnormal test result that the trial doctor believes could interfere with the study results or would make participation unsafe.

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