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 have given written consent and are able to attend scheduled visits and follow study procedures
• People aged 18 to 75 years, of any gender
• People diagnosed with liver cancer (hepatocellular carcinoma, or HCC) according to Chinese national guidelines or confirmed by biopsy, with at least one measurable tumour
• People whose liver cancer has spread into the portal vein (a major blood vessel near the liver) in a specific way classified as Cheng's type I, II, or III, and whose main tumour can be surgically removed
• People whose liver is functioning well, as measured by a Child-Pugh score of Class A (a standard liver health rating)
• People who are generally able to carry out daily activities, with a performance score of 0 or 1 on a standard medical scale (ECOG scale)
• People who have not previously received any cancer treatment, including surgery, radiation, chemotherapy, targeted therapy, immunotherapy, or any other cancer-related treatment
• People with hepatitis B virus (HBV) infection who have had their virus levels tested; the trial site will determine whether antiviral treatment is needed before starting the study, and all HBV-positive participants will receive antiviral treatment throughout the study; people with active hepatitis C must also receive antiviral treatment as per medical guidelines
• People who are able to provide a fresh tumour tissue sample and blood samples during the screening period (this requirement may be waived after discussion with the medical team)
• People with an expected survival of at least 12 weeks
• People whose blood counts, liver function, kidney function, and blood clotting levels meet specific laboratory thresholds set by the trial (confirm with trial site for exact values)
• Women who could become pregnant must agree to use effective contraception or abstain from heterosexual intercourse from the time of signing consent until at least 120 days after the last dose, must not be breastfeeding, and must have a negative pregnancy blood test within one week before starting treatment
• Male participants with partners who could become pregnant must agree to use effective contraception or abstain from heterosexual intercourse from the time of signing consent until at least 120 days after the last dose, and must not donate sperm during this period; male participants whose partners are pregnant must use condoms

Who may not be able to join:

• People whose portal vein tumour has spread to the branch on the opposite side of the tumour, or whose cancer has spread to the large vein near the spine (inferior vena cava), to areas outside the liver, or has grown into nearby organs
• People with certain less common types of liver cancer (such as intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed-cell carcinoma, or fibrolamellar carcinoma), or people who have had another cancer in the past 5 years (some fully treated skin or surface cancers may be exceptions — confirm with trial site)
• People who currently have, or have a history of, certain lung conditions such as interstitial lung disease, pulmonary fibrosis, drug-related lung inflammation, or active tuberculosis
• People with active autoimmune diseases (where the immune system attacks the body) or a history of autoimmune conditions that may return; some milder conditions or those well-controlled with treatment may be allowed (confirm with trial site)
• People who have taken immune-suppressing medications or high-dose steroid medications within the 2 weeks before starting the study
• People with an active infection, unexplained fever of 38.5°C or above in the week before the study, abnormally high white blood cell count, or who have taken antibiotic treatment by mouth or intravenously within 2 weeks before starting
• People with a known immune deficiency condition, such as HIV infection
• People who have received a live vaccine within 4 weeks before starting the study, or who are expected to need one during treatment or within 60 days after the last dose
• People who have had significant bleeding episodes within the 6 months before starting, such as stomach or bowel bleeding or bleeding from blood vessel inflammation
• People with known inherited or acquired bleeding or clotting disorders (such as haemophilia), or who are currently taking full-dose blood-thinning or clot-dissolving medications (low-dose preventive aspirin may be allowed)
• People who have had a stroke, mini-stroke (TIA), brain bleed, brain infarction, severe deep vein blood clot, or pulmonary embolism within the 6 months before starting
• People with uncontrolled heart conditions, including moderate-to-severe heart failure, unstable chest pain (angina), a heart attack within the past year, significant heart rhythm problems, or certain abnormal heart electrical readings
• People with poorly controlled high blood pressure (blood pressure of 140/90 mmHg or above despite medication), or a history of hypertensive crisis or brain swelling caused by high blood pressure
• People who have had major blood vessel disease or surgery within the 6 months before starting
• People with severe, non-healing wounds, open sores, or untreated bone fractures
• People who have had major surgery (not counting diagnostic procedures) within 4 weeks before starting
• People who are unable to swallow tablets, or have conditions that affect how the gut absorbs medication
• People who have had a bowel obstruction or related symptoms within the 6 months before starting (some people who had this resolved by surgery may be eligible — confirm with trial site)
• People who have taken certain medications that strongly affect how the body processes drugs (specific CYP3A4/CYP2C19 inducers or inhibitors, such as rifampin or St John's Wort) within 2 weeks before starting
• People with a known allergy to any monoclonal antibody, anti-blood-vessel targeted drugs, or their inactive ingredients
• People who have participated in another drug clinical trial within the 12 weeks before starting

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