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 aged 18 to 75 years old, of any gender
• People who have been diagnosed with primary liver cancer (hepatocellular carcinoma), confirmed by tissue testing or clinical assessment
• People whose liver cancer came back within 3 years after surgery or ablation treatment to remove the original tumour, where imaging scans taken at least 2 months after that treatment showed no remaining tumour, and where the cancer has not spread outside the liver
• People whose general health and ability to carry out daily activities falls within a certain range (ECOG score 0–1 — confirm with trial site what this means for individual circumstances)
• People whose returned liver cancer meets specific size and spread limits: either a single tumour no larger than 5cm, or up to 3 tumours each no larger than 3cm, with no major blood vessel involvement and no spread to lymph nodes or outside the liver
• People with liver function rated as Child-Pugh grade A or B (a measure of how well the liver is working — confirm with trial site)
• People with an expected survival of more than 6 months
• People whose blood, heart, liver, and kidney test results fall within the required ranges, and who have not needed blood transfusions or growth factor treatments in the 2 weeks before joining
• People with high blood pressure whose blood pressure is being successfully controlled with medication
• People with diabetes whose fasting blood sugar is being controlled to 8 mmol/L or below with medication
• People who do not have other serious conditions (such as autoimmune diseases, immune deficiency, or a history of organ transplantation) that would conflict with the trial treatment
• People with no history of other cancers
• Women who could become pregnant must have a negative blood pregnancy test within 7 days before joining, and all participants who could father or carry a child must use appropriate contraception during the trial and for 6 months after it ends
• People who agree to take part and have signed the informed consent form

Who may not be able to join:

• People who have previously received radiotherapy, hormone therapy, or targeted drug therapy for their liver cancer
• People whose imaging scans confirm the cancer has spread to distant parts of the body
• People who have had or currently have another cancer (other than certain treated skin cancers or early-stage cervical cancer that has been cured)
• People known to be allergic to large protein-based medicines or to any ingredient in anti-PD-1 antibody treatments
• People who have a history of active autoimmune disease (such as autoimmune hepatitis, certain lung conditions, eye inflammation, bowel inflammation, or thyroid disorders, among others) — some exceptions may apply (confirm with trial site)
• People who are currently taking immunosuppressant medications or steroid medications at higher than specified doses, or who were doing so within the 2 weeks before joining
• People with significant heart problems that are not well controlled, including moderate-to-severe heart failure, unstable chest pain (angina), a heart attack within the past year, or certain serious heart rhythm problems requiring treatment
• People with abnormal blood clotting test results, a tendency to bleed, or who are currently receiving blood-thinning or clot-dissolving therapy
• People who currently have (within the past 3 months) certain digestive tract conditions such as swollen veins in the oesophagus, active stomach or bowel ulcers, inflammatory bowel disease, or conditions likely to cause bleeding or perforation in the gut
• People who have had significant bleeding (more than 30ml within 3 months), coughing up fresh blood (more than 5ml within 4 weeks), or a stroke or similar event within the past 12 months
• People with evidence of lung scarring, lung inflammation, or significantly reduced lung function
• People with HIV infection or active hepatitis B or C (people who carry hepatitis B at low levels may still be considered if they receive antiviral treatment throughout the trial — confirm with trial site)
• People currently taking part in another clinical trial, or who finished another clinical trial less than one month ago, or who may need other systemic cancer treatments during this trial
• People with a known history of substance abuse, alcohol dependence, or drug misuse
• People whose imaging scans showed tumour recurrence or spread within 2 months of their surgery
• People whom the trial investigators believe should be excluded for other medical, mental health, or safety-related reasons

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