Phase 4 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 have given written consent before any trial-related procedures begin
• People aged between 18 and 75 years (male or female)
• People who are fully active or have only minor restrictions in physical activity (as measured by a standard performance scale called ECOG, with a score of 0 or 1)
• People who have been confirmed by tissue or cell testing to have hepatocellular carcinoma (a type of liver cancer), or whose diagnosis meets specific Chinese clinical guidelines for liver cancer
• People who have not received any treatment for liver cancer before surgery — including chemotherapy, targeted therapy, immunotherapy, radiation, or procedures to the liver — and whose scans show no spread to lymph nodes or distant organs, and who have been assessed as suitable for surgery aimed at removing all cancer
• People who have at least one feature after surgery that raises the risk of cancer returning, such as: a single tumour larger than 5 cm; cancer found in blood vessels (small or large); more than 3 tumour nodules; a higher-grade tumour on pathology testing; a protein called AFP above 400 μg/L in certain cancer stages; a tumour located close to blood vessels in certain cancer stages; or an incomplete tumour capsule in certain cancer stages
• People whose liver function falls within an acceptable range on a scoring system called Child-Pugh (score A or B7)
• People whose life expectancy is more than 3 months
• People who have at least one measurable area of cancer that can be tracked on scans, according to standard measurement rules (RECIST 1.1)
• People whose thyroid hormone levels are within normal range, or who are on thyroid replacement therapy, or who have abnormal thyroid hormone levels but no symptoms (confirm with trial site)
• People whose blood, liver, kidney, and clotting test results meet specific thresholds within 7 days before joining (these tests must be done without recent use of blood products, growth factors, albumin, or corrective treatments in the 14 days before testing)
• Women who could become pregnant must have a negative pregnancy test within 3 days before the first dose
• All participants with any possibility of pregnancy must use effective contraception throughout treatment and for 120 days after the last dose of the study drug (or 180 days after the last chemotherapy dose)

Who may not be able to join:

• People whose liver cancer has been identified as a specific less common type, such as fibrolamellar, sarcomatoid hepatocellular carcinoma, or bile duct cancer
• People who have had another cancer in the past 5 years, with exceptions for certain low-risk skin cancers, superficial bladder cancer, or early-stage cervical or breast cancer
• People with a history of brain complications from liver failure (hepatic encephalopathy) or who have had a liver transplant
• People who have cancer blocking major blood vessels connected to the liver or lower body
• People with active hepatitis B or C infection where the virus levels in the blood are above certain thresholds (people on antiviral treatment who are willing to continue may still be considered — confirm with trial site)
• People with fluid build-up in the chest, abdomen, or around the heart that requires draining
• People who have had bleeding from enlarged veins in the food pipe or stomach (caused by liver pressure) in the past 6 months, or whose scans currently show significant enlarged veins in those areas
• People with a history of serious bleeding problems or blood clotting disorders, or who have had a clinically significant bleed in the past month, or who have been on blood-thinning or anti-clotting medication in the 10 days before the first dose
• People who have had a blood clot event in the past 6 months, such as a heart attack, unstable chest pain, stroke, mini-stroke, blood clot in the lungs, or deep vein thrombosis (some exceptions apply — confirm with trial site)
• People with a history of heart muscle disease, dangerous heart rhythm problems, or heart failure; or who have been hospitalised for heart or vascular problems in the past 12 months; or who have serious unhealed wounds, stomach or bowel complications, or uncontrolled high blood pressure (above 150/90 mmHg)
• People who have had or currently have a lung condition called interstitial lung disease requiring steroid treatment; or inflammatory bowel disease; or an active autoimmune condition requiring systemic treatment in the past 2 years (thyroid hormone replacement, insulin, or similar replacement therapies are not considered systemic treatment)
• People with a weakened immune system, a positive HIV test, or who are currently on long-term systemic steroids or immune-suppressing medications
• People with known active tuberculosis or active syphilis infection
• People who have had a serious infection requiring hospitalisation within the past 4 weeks, or who are currently being treated with antibiotics or antifungals for an active infection (hepatitis B or C antiviral therapy is not included in this restriction)
• People who have previously received systemic chemotherapy or treatment with the drug bevacizumab or a similar drug
• People who have previously received any type of immunotherapy, including checkpoint inhibitor drugs (such as anti-PD-1 or anti-CTLA-4 treatments)
• People who have previously had local liver treatments such as certain catheter-based or radiation-based liver procedures (TACE, TARE, HAIC, or liver radiotherapy)
• People who have used certain anti-tumour traditional Chinese medicines or immune-modulating drugs within the 2 weeks before the first dose
• People who have received a live or weakened (attenuated) vaccine within 30 days before the first dose, or who plan to receive one during the trial (inactivated vaccines are permitted)
• People with a known allergy to any component of the study drugs, or a history of severe allergic reactions to other antibody-based medicines
• People with a known psychiatric illness, or current problems with drug, alcohol, or substance misuse
• Women who are pregnant or breastfeeding
• People with any other condition or situation that the trial doctor believes could interfere with the study or pose additional risk

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