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 willing and able to sign a written consent form before any study procedures begin
• People aged 18 years or older
• People who have been diagnosed with locally advanced, metastatic, or inoperable liver cancer (hepatocellular carcinoma), confirmed either by tissue sample or through established clinical diagnostic guidelines
• People whose liver cancer includes at least one area measuring 3 cm or larger, located at least 1 cm away from sensitive structures such as major blood vessels, bile ducts, the heart lining, diaphragm, gallbladder, stomach, or bowel
• People who are not suitable for local treatments alone, such as liver transplant, tumour ablation, embolisation, radiation, or surgical removal
• People who have not previously received any systemic (whole-body) treatment for advanced or metastatic liver cancer
• People with a general health and activity level rated as fully active or restricted in strenuous activity only (ECOG score of 0 or 1)
• People with measurable tumour areas that can be tracked according to standard imaging criteria
• People with liver function rated as Child-Pugh A or Child-Pugh B7 (a measure of how well the liver is working)
• People with a life expectancy of at least 12 weeks
• People with adequate bone marrow function, meaning blood cell counts meet minimum required levels (confirm specific values with trial site)
• People with adequate kidney function, based on a kidney filtration rate of at least 50 ml/min
• People with adequate liver and pancreatic function, based on blood test results within acceptable ranges (confirm specific values with trial site)
• People with a seizure disorder may be eligible if their seizures are well controlled with medication
• People with a resting systolic blood pressure below 160 mmHg
• People with a partner who could become pregnant must agree to use adequate contraception throughout the study
• People who could become pregnant are eligible if they either cannot become pregnant for medical reasons (such as having had a hysterectomy, removal of both ovaries, tubal ligation, or being post-menopausal for at least one year), or if they have a negative pregnancy blood test at screening and agree to use an approved form of contraception throughout the study and for at least 14 days after the last dose

Who may not be able to join:

• People with cancer that has spread to the brain or spinal cord, unless treatment for this was completed at least 4 weeks before entering the study and the condition has been stable without steroid treatment for at least 4 weeks
• People with severe or uncontrolled serious illness, such as unstable breathing or heart problems including dangerous heart rhythm issues
• People with ongoing side effects from previous cancer treatment rated as moderate or worse (Grade 2 or above), except for hair loss, unless an exception is agreed upon with the study medical team
• People with significant heart problems, including heart failure classified as severe (NYHA Class III or IV), a heart attack or active heart disease within the past year, uncontrolled irregular heart rhythms, or poorly controlled chest pain (angina)
• People who have taken part in another clinical trial involving an experimental treatment within the past 30 days
• People who are pregnant or breastfeeding
• People who have large fluid build-ups in the abdomen or lungs that require draining more than once every 14 days
• People with severe or uncontrollable confusion caused by liver disease (Grade 3–4 hepatic encephalopathy)
• People who have previously received a stem cell transplant or solid organ transplant
• People with a prior history of lung inflammation (pneumonitis) or scarring lung disease (interstitial lung disease)
• People who have received a live vaccine within the past 30 days
• People with an active or previously diagnosed autoimmune or inflammatory condition (such as lupus, rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, or similar conditions), with some exceptions including vitiligo, hair loss, well-controlled underactive thyroid on medication, certain skin conditions not needing systemic treatment, controlled Type 1 diabetes managed with insulin, celiac disease controlled by diet alone, or conditions with no active disease in the last 5 years
• People who have used immunosuppressive medications within 14 days before the first study dose, with some exceptions such as low-dose inhaled, nasal, or topical steroids, very low-dose systemic steroids, or steroids used to prevent allergic reactions to scans
• People with any other condition that, in the treating doctor's opinion, would make participation unsuitable or unsafe

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