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 give voluntary written consent to participate
• People aged 18 to 75 years, of any gender
• People who have been diagnosed with hepatocellular carcinoma (a type of liver cancer) that has not been treated before — either confirmed through a tissue sample or diagnosed using recognised medical guidelines
• People whose liver cancer has been assessed by the study doctor as suitable for surgery, with the expectation of complete removal of the tumour, enough healthy liver remaining, and good overall liver function
• People who have at least one tumour that can be measured using standard imaging guidelines (called mRECIST)
• People whose tumour burden meets one of these conditions: a single tumour larger than 5 cm; multiple tumours (fewer than 5 in total) where the largest is bigger than 3 cm; or cancer that has grown into nearby smaller branches of the portal vein (a specific blood vessel in the liver), classified as Vp1 or Vp2
• People with a liver function score of 5 or 6 on the Child-Pugh scale (indicating reasonably well-functioning liver)
• People with a general health and activity level rated 0 or 1 on the ECOG scale (meaning fully active or able to carry out light activities)
• People with a life expectancy of at least 3 months
• Women who could become pregnant must have a negative blood pregnancy test within 7 days before starting the study treatment
• Both women and men who could have children must use reliable contraception throughout the study and for 60 days after the last dose of the study treatment
• People with a hepatitis B infection must have their hepatitis B virus levels managed and reduced to an acceptable level before entering the study, and must continue antiviral treatment with regular monitoring throughout the trial
• People with adequate functioning of key organs such as the kidneys, liver, and blood cells (confirm with trial site for specific values)

Who may not be able to join:

• People whose cancer has spread to distant parts of the body (metastasis)
• People whose cancer has grown into larger or main branches of the portal vein, classified as Vp3 or Vp4
• People who have had another type of cancer in the past 5 years, unless they received treatment that may have fully cured it and there is no sign of it returning — though this 5-year rule does not apply to certain skin cancers, superficial bladder cancer, or early-stage cancers that were successfully removed
• People with a history of, or currently living with, a condition where the immune system does not work properly, whether present from birth or developed later in life
• People with active or previously diagnosed autoimmune conditions or ongoing inflammatory disorders — such as autoimmune hepatitis, lupus, inflammatory bowel disease, certain thyroid conditions, or asthma requiring regular medication (though people with vitiligo or childhood asthma that fully resolved and requires no treatment as adults may still be eligible)
• People with a history of severe mental health disorders
• People with conditions that significantly affect how the body processes medications, such as severe vomiting, ongoing diarrhoea, bowel obstruction, or malabsorption
• People who have had major surgery within 4 weeks before enrolling in the trial
• People who have had an organ transplant or stem cell transplant from another person (corneal transplants are an exception)
• People who have received other cancer treatments within 2 weeks, or 5 half-lives of the drug (whichever is longer), before starting the study, or who still have unresolved side effects from previous treatments above a mild level
• People who have used systemic immune-suppressing medications within 2 weeks before enrolling, or who are expected to need them during the study
• People currently taking medications that may affect heart rhythm in a specific way (QTc prolongation or Tdp risk) or that may interfere with how the study drugs are processed by the body
• People with a known or suspected allergy to the study drugs (donafenib or the anti-PD-1 antibody) or to similar types of medications or their ingredients
• People with uncontrolled liver-related complications such as hepatic encephalopathy, hepatorenal syndrome, or significant fluid build-up in the abdomen, chest, or around the heart
• People with active bleeding, blood clotting problems, or who are currently taking blood thinners or clot-dissolving medications
• People who have had gastrointestinal bleeding or significant signs of bleeding risk in the past 6 months, such as active ulcers or severe varicose veins in the oesophagus or stomach
• People who have had a gastrointestinal perforation, abdominal fistula, or abscess in the abdomen within the past 6 months
• People who have had a blood clot event — such as a stroke, mini-stroke, deep vein thrombosis, or pulmonary embolism — within the past 6 months
• People with significant heart conditions, including recent heart attack, severe chest pain, recent heart bypass surgery, significant heart failure, uncontrolled irregular heartbeat requiring a pacemaker, or blood pressure that remains high despite treatment
• People with an active infection at the time of enrolment
• People with other significant medical or laboratory findings that could affect safety assessment, such as uncontrolled diabetes, chronic kidney disease, moderate to severe nerve damage in the hands or feet, or thyroid problems
• People who have received a live attenuated vaccine within 4 weeks before enrolling or during the study
• Women who are pregnant or breastfeeding, or anyone who could have children but is unwilling or unable to use effective contraception
• People with a history of alcohol, drug, or substance misuse in the past 6 months
• People who have taken part in another clinical trial involving an experimental drug or device within 4 weeks before enrolling
• People who are unable to follow the study's treatment schedule or attend required follow-up visits
• People who, in the study doctor's judgement, have any other condition that would make participation unsuitable

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