Phase 2 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 are willing to take part voluntarily and sign a consent form.
• People who have been diagnosed with hepatocellular carcinoma (a type of liver cancer) either through a tissue/cell sample test or according to recognised clinical guidelines (2024 Edition).
• People who had surgery to fully remove their liver cancer between 4 and 12 weeks before joining the trial.
• People who have fully recovered from that surgery within 4 weeks before joining.
• People whose cancer has certain features that raise the risk of it coming back after surgery, such as: more than one tumour, a tumour larger than 5 cm, poorly formed cancer cells, a surgical margin of 1 cm or less, cancer that has grown into blood vessels, spread to lymph nodes, or ongoing abnormal blood marker levels (confirm with trial site).
• People whose liver is functioning at a certain level, measured by a scoring system called Child-Pugh, rated A or B (up to 7 points), checked within 7 days before joining.
• People who are reasonably active in daily life, based on a standard activity scale (ECOG score of 0 or 1), checked within 7 days before joining.
• People who have not previously received any systemic (whole-body) treatment for their liver cancer.
• People expected to live for at least 12 weeks.
• People whose major organs (blood, liver, kidneys) are working well enough to meet specific laboratory test requirements checked within 7 days before joining (confirm exact values with trial site).
• People with hepatitis B who are willing to take antiviral medication throughout the study and have regular monitoring; people with hepatitis C who are already receiving appropriate antiviral treatment with liver function within an acceptable range.
• Women who are able to become pregnant must agree to use contraception from signing the consent form until at least 90 days after the last dose of study treatment, must have a negative pregnancy blood test within 7 days before starting treatment, and must not be breastfeeding.

Who may not be able to join:

• People with certain other types of liver or bile duct cancers, or who have had another active cancer within the past 5 years (not including treated skin basal cell carcinoma or cervical carcinoma in situ).
• People whose cancer has spread to organs outside the liver in a way that cannot be controlled, such as the lungs or brain.
• People who have previously had certain local liver treatments, such as chemotherapy delivered directly to the liver's blood supply (TACE, HAIC), or similar procedures.
• People who have had, or are planning to have, an organ transplant or bone marrow transplant from a donor.
• People who currently have, or have a history of, lung inflammation conditions such as interstitial lung disease, pulmonary fibrosis, or active tuberculosis, or whose chest scan shows signs of active pneumonia or severely reduced lung function.
• People with an active autoimmune disease (where the body's immune system attacks itself) or a history of one that may come back — with some exceptions, such as certain skin conditions, controlled type 1 diabetes managed with insulin, or childhood asthma that resolved without treatment (confirm with trial site).
• People with high blood pressure that cannot be brought under control with medication (consistently at or above 140/90 mmHg), or who have previously had a hypertensive crisis or hypertensive encephalopathy.
• People with moderate to severe fluid build-up in the abdomen requiring draining, a Child-Pugh liver score above 7, or uncontrolled fluid around the lungs or heart.
• People with significant heart problems, including: heart failure at a certain level, unstable chest pain, a heart attack within the past year, serious heart rhythm problems, or an abnormal heart electrical reading (QTc above 480ms).
• People who have had a spontaneous rupture (sudden burst) of a liver tumour in the past.
• People with a history of hepatic encephalopathy (a condition where the liver cannot properly remove toxins, affecting the brain).
• People with known immune system deficiencies, whether from birth or acquired (such as HIV infection).
• People who have had a blood clot, stroke, or pulmonary embolism (blood clot in the lungs) within the 6 months before starting treatment.
• People with a history of gastrointestinal bleeding or a clear risk of bleeding in the digestive system within the past 6 months, including significant varicose veins in the oesophagus or stomach, active ulcers, or persistently positive stool blood tests (confirm with trial site).
• People who have had an abdominal fistula, bowel perforation, or abdominal abscess within the 6 months before starting treatment.
• People with severe, unhealed, or open wounds, active ulcers, or untreated broken bones.
• People with known bleeding or clotting disorders (such as haemophilia), or those currently using full-dose blood-thinning or clot-dissolving medications within 10 days before starting treatment (low-dose aspirin or preventive low-molecular-weight heparin is allowed).
• People who have had a major blood vessel problem, such as an aortic aneurysm or arterial blood clot, within the 6 months before starting treatment.
• People who had a serious infection within 4 weeks before starting treatment, or who have taken antibiotic tablets or injections for treatment purposes within 2 weeks before starting (preventive antibiotic use may be allowed — confirm with trial site).
• People with a known allergy or serious sensitivity to the study drugs (Adebrelimab or Apatinib) or to similar types of medicines.
• People who have used immune-suppressing medications or steroid treatments above a certain dose within 14 days before starting the study.
• People who received a live vaccine within 28 days before starting treatment, or who are expected to need one during treatment or within 60 days after the last dose of Adebrelimab.
• People who have taken part in another experimental drug trial within 28 days or 5 half-lives of that drug (whichever is longer) before starting this study.
• People who, in the judgment of the research team, have other factors that could affect the study results or their safety, such as serious alcohol or substance use, significant mental health conditions, or family and social circumstances that may place them at risk.

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