Phase 1 Liver Cancer Trial, Recruiting

Written by an AI model from the 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 have signed a written consent form approved by the relevant ethics board.
• People aged between 18 and 65 years old at the time of signing the consent form.
• People who weigh between 50 kg and 85 kg.
• People who have been diagnosed with hepatocellular carcinoma (a type of liver cancer) confirmed by tissue testing, where the cancer is at an advanced stage — meaning it cannot be removed by surgery or local treatments, or it has continued to grow after those treatments. A scan-based diagnosis may allow entry into the screening phase, but tissue confirmation is required before full enrolment.
• People who have at least one tumour that can be measured on a scan, assessed within 4 weeks before the first dose, and that has not previously been treated with surgery, radiation, or local therapies.
• People who have not previously received whole-body (systemic) drug treatments for advanced or metastatic liver cancer. Prior treatment given before or after surgery is allowed if the cancer came back 12 or more months after that treatment finished.
• People whose physical functioning is rated at the highest level on a standard scale used by doctors (ECOG score of 0, meaning fully active), assessed within 7 days before the first dose.
• People whose liver function falls within a specific category called Child-Pugh Class A (a measure of how well the liver is working), assessed within 7 days before the first dose.
• People whose heart pumping function is at 50% or above, as measured by a heart ultrasound.
• People whose major organs (such as kidneys, liver, and bone marrow) are functioning within normal ranges before the first dose.
• People with active hepatitis B virus must have a viral load below a certain level within 28 days before enrolment, must have already started hepatitis B treatment, and must be willing to continue that treatment throughout the study. People with active hepatitis C must agree to receive standard antiviral treatment.
• Women who could become pregnant must have a negative pregnancy test at the screening visit and again before the first dose.

Who may not be able to join:

• People whose liver cancer is of a specific rare subtype, including fibrolamellar, sarcomatoid, or mixed liver and bile duct cancer.
• People who have had another active cancer within the past 3 years, unless it was a localised cancer that has been fully treated, such as certain skin cancers, early bladder cancer, or non-invasive cancers of the prostate, cervix, or breast.
• People who have had a liver transplant, any organ transplant, or a bone marrow transplant, or who are scheduled to have one during the study.
• People who have a history of hepatic encephalopathy (a condition where the liver cannot remove toxins, affecting brain function).
• People who have significant fluid build-up in the abdomen (ascites).
• People who have cancer that has grown into certain major blood vessels near the liver or bile ducts, or where the cancer takes up 50% or more of the liver.
• People who have nervous system disorders at the time of screening (confirm with trial site).
• People who have had bleeding from veins in the oesophagus or stomach due to high blood pressure in the liver within the past 6 months, unless an endoscopy has been done to confirm low bleeding risk.
• People who have had a serious bleeding event (above a certain severity level) within the past 3 months, not related to oesophageal or gastric veins.
• People who have had wounds, bone fractures, or ulcers that are at risk of bleeding and have not healed, within 3 months before enrolment.
• People who have had a major operation, open biopsy, or serious injury within 28 days before enrolment, or a minor surgical procedure within 7 days before enrolment.
• People with known active or suspected autoimmune diseases, unless their condition is stable and does not require immune-suppressing medicines.
• People who have taken high-dose steroid medicines or other immune-suppressing treatments within 14 days before the first dose or during the study (low-dose inhaled or skin-applied steroids may be allowed — confirm with trial site).
• People who are actively infected with both hepatitis B and hepatitis C at the same time, or who have hepatitis D alongside hepatitis B.
• People who have a history of being infected with both hepatitis B and hepatitis C.
• People who have HIV infection, or who test positive for HIV at screening.
• People who have an active infection requiring whole-body antibiotic or antiviral treatment within 14 days before screening.
• People who have had uncontrolled heart or cardiovascular conditions within the past 6 months.
• People with known lung conditions such as interstitial lung disease, radiation-related lung damage, or significantly reduced lung function.
• People who have used traditional Chinese herbal medicines with anti-cancer properties within 14 days before enrolment.
• People who have received a live vaccine within 28 days before enrolment (inactivated flu or COVID-19 vaccines are generally allowed).
• People who have previously been treated with certain immune checkpoint or T-cell targeting therapies, including drugs such as CTLA-4 inhibitors, PD-1 inhibitors, or PD-L1/PD-L2 inhibitors.
• People who have had intensive (radical) radiotherapy within 4 weeks before enrolment.
• People who are currently taking certain medicines that may interact with the study drugs, including strong CYP3A4 inducers (such as rifampin or St. John's wort) within 1 week before enrolment, certain blood thinners that require regular INR monitoring (such as warfarin), or high-dose anti-platelet medicines such as high-dose aspirin or clopidogrel.
• People with any other serious or uncontrolled medical condition that, in the doctor's judgement, could affect safety or the trial results.
• People who have had a severe allergic reaction to ipilimumab, nivolumab, any other monoclonal antibody, or any ingredient in the study medicines.
• People with a history of abusing psychotropic substances or illegal drugs, as assessed by the doctor.
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study or within 5 months after the last dose.
• People who are currently in another clinical trial, or who have not waited long enough since finishing a previous trial (at least 4 weeks or 5 half-lives of the previous study drug, whichever is longer).
• People who have any other condition that the treating doctor considers unsuitable for participation.

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