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 to take part and sign a consent form agreeing to participate.
• Adults aged 18 or older, of any gender.
• People who have been diagnosed with liver cancer (HCC) confirmed by a tissue or cell sample, or with liver cirrhosis meeting specific liver disease guidelines.
• People whose liver cancer is at an intermediate or advanced stage, as defined by recognised liver cancer staging systems, and whose cancer has been assessed as not suitable for surgery or local treatments.
• People who have not previously received systemic treatments for liver cancer (such as chemotherapy, targeted therapy, or immunotherapy); some earlier use of certain targeted drugs is allowed if the last dose was taken at least 90 days before starting the trial.
• People who have at least one measurable tumour that meets specific imaging criteria under standard measurement guidelines (RECIST v1.1).
• People whose liver function is rated as Child-Pugh class A, or class B with a score of 7 or below, and who have no history of a condition called hepatic encephalopathy (a type of brain confusion caused by liver disease).
• People who are reasonably active and able to care for themselves, with a performance score of 0 or 1 on a standard medical scale (ECOG).
• People whose life expectancy is at least 12 weeks.
• People whose heart, kidney, blood, and other major organ functions meet specific blood test requirements, without having needed blood transfusions or certain medical boosters in the 14 days before screening.
• People of childbearing potential who agree to use highly effective contraception during the trial and for at least 6 months after the last dose; women of childbearing potential must also have a negative pregnancy blood test within 7 days before starting and must not be breastfeeding.

Who may not be able to join:

• People who have had major surgery requiring general anaesthesia and more than 24 hours in hospital, a live vaccine, or an experimental drug treatment within the 4 weeks before starting, or palliative radiotherapy to a bone or brain area within 2 weeks before starting.
• People who have been taking ongoing high-dose steroid tablets or other immune-suppressing medicines within 7 days before starting.
• People whose liver tumours make up more than 50% of the total liver volume at the time of screening.
• People whose cancer has grown into the main trunk of the portal vein (a major blood vessel to the liver), blocking more than half of it, as confirmed by CT or MRI scan.
• People who have liver cancer that has spread to the brain or spinal cord.
• People who still have significant side effects (above a mild level) from previous cancer treatments, apart from hair loss or certain nerve-related issues.
• People who have had a serious infection during the screening period, including hospitalisation for infection, bacteria in the bloodstream, severe pneumonia, a course of antibiotic treatment lasting 7 or more days within the 14 days before starting, an unexplained fever of 38.5°C or higher within 7 days before starting, or a very high white blood cell count at baseline.
• People with uncontrolled fluid build-up around the heart, lungs, or abdomen that is causing symptoms or requires drainage treatment.
• People with a severe internal fistula (an abnormal channel between body parts, rated grade 3 or above on a standard medical scale) during the screening period.
• People with severe unhealed wounds, active ulcers, or an untreated bone fracture at the time of screening.
• People with serious heart or cardiovascular disease (confirm with trial site for specific conditions).
• People who have had a digestive tract bleed within the 6 months before starting, or who have signs of a clear bleeding risk, including certain high-risk vein problems in the oesophagus or stomach, active ulcers, or persistently positive stool blood tests after repeat testing and endoscopy.
• People with other bleeding disorders or significant problems with blood clotting.
• People who have had a bowel obstruction within the 6 months before starting, or who currently have symptoms of one, unless it was fully resolved by surgery before starting.
• People with an active autoimmune condition that required systemic medical treatment within the 2 years before starting (routine hormone replacement therapies are generally not considered systemic treatment under these criteria — confirm with trial site).
• People who have had another cancer (other than liver cancer) within the 5 years before starting, or who have a mixed type of liver cancer; some fully cured localised cancers may be exceptions (confirm with trial site).
• People with a history of a lung condition called interstitial lung disease or non-infectious pneumonitis, unless it was caused by radiotherapy to a specific area.
• People with active tuberculosis, or who have received tuberculosis treatment within the year before starting.
• People with certain hepatitis B or C virus infection levels that exceed specified limits, or who have both hepatitis B and C infections at the same time (those with hepatitis B or C within certain limits may still be eligible if they are on or start appropriate antiviral treatment — confirm with trial site).
• People with a known history of HIV infection, a previous organ or stem cell transplant from a donor, or other immune deficiency conditions.
• People with a known severe allergy to any monoclonal antibody medicines.
• People who, in the opinion of the trial doctor, have other factors that could affect the safety of the study or its results, such as serious alcohol or substance use, serious mental health conditions, or significant social or family circumstances affecting their safety.

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