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 aged 18 to 75 years (any gender) who are willing and able to give written consent before any trial procedures begin, or whose legal representative is able to do so on their behalf.
• People whose liver cancer (hepatocellular carcinoma, or HCC) was confirmed by a pathologist after surgery, and whose tumour had burst and bled, as shown by imaging before or during the operation. For cases where the rupture was only discovered during surgery, a history of abdominal pain in the two weeks before surgery is also required.
• People whose cancer is classified as CNLC Stage I or II (an early-to-intermediate staging system used in China for liver cancer).
• People who have had curative surgery to remove the tumour, where the surgeon washed out the abdomen with at least 5,000 mL of distilled water or saline during the operation, where lab tests confirmed the removed tissue had clear (cancer-free) margins, and where imaging done 4–8 weeks after surgery confirmed no remaining signs of cancer.
• People with a good general physical functioning level, rated 0 or 1 on the ECOG scale (meaning fully active or able to carry out light activities).
• People whose liver is functioning well enough to score a Child-Pugh grade A, with a score of 6 or below (a measure of liver health).
• People with a life expectancy of at least 12 months.
• People whose blood test results, taken within 3 days before the first dose, meet all of the following: sufficient levels of neutrophils (infection-fighting white blood cells), platelets (clotting cells), and haemoglobin (a measure of red blood cells); adequate levels of a blood protein called albumin; bilirubin (a waste product processed by the liver) within acceptable limits; liver enzyme levels (ALT and AST) within acceptable limits; kidney function within acceptable limits; blood clotting time within acceptable limits; and urine protein levels below a certain threshold (confirm with trial site for exact values).
• People with hepatitis B (HBV) infection whose virus levels in the blood are below a certain threshold, or who have already received at least one week of approved antiviral treatment that has significantly reduced virus levels. All people with hepatitis B would need to continue antiviral treatment throughout the trial. People with active hepatitis C (HCV) would need to be on antiviral treatment as directed by current medical guidelines.
• Women who could become pregnant must have a negative pregnancy test before the first dose. Women who could become pregnant, and men whose partners could become pregnant, must agree to use effective contraception during the trial and for 6 months after the last dose.

Who may not be able to join:

• People whose cancer type, confirmed by a pathologist, is something other than hepatocellular carcinoma — for example, bile duct cancer (cholangiocarcinoma) or a mixed liver-bile duct cancer.
• People who received chemotherapy drugs washed into the abdomen during surgery.
• People whose liver function is rated Child-Pugh class B or C (indicating more significant liver impairment).
• People with a physical functioning score above 1 on the ECOG scale (meaning those who are significantly limited in daily activities).
• People whose post-surgery imaging shows that cancer has spread outside the liver, or that cancer remains or has come back.
• People who have previously received systemic cancer treatments such as targeted therapy, immunotherapy, or experimental drugs, or local treatments such as TACE (a procedure that delivers treatment directly to liver tumours). Note: a procedure to stop bleeding before surgery (TAE for haemostasis) is allowed. People who received TACE after surgery are also excluded.
• People with moderate or severe fluid build-up in the abdomen (ascites) that requires draining, or a Child-Pugh ascites score above 2. Also excluded are people with uncontrolled or significant fluid around the lungs or heart.
• People with current or past lung inflammation (interstitial lung disease or ILD) that required steroid treatment, or other lung conditions such as pulmonary fibrosis, certain types of pneumonia, dust-related lung disease, or drug-related lung damage. Also excluded are people with signs of active pneumonia on a pre-trial chest scan, severely reduced lung function, or active tuberculosis.
• People with an active autoimmune disease (where the immune system attacks the body), or a history of autoimmune conditions that could come back — such as autoimmune hepatitis, immune-related lung, eye, bowel, or kidney inflammation, or thyroid conditions. Some exceptions apply, such as people with skin conditions like vitiligo or psoriasis not needing systemic treatment, well-controlled type 1 diabetes managed with insulin, or childhood asthma fully resolved in adulthood. People with asthma still needing bronchodilator medication are excluded (confirm with trial site for specific conditions).
• People who have taken immune-suppressing medications or high-dose steroids (above the equivalent of 10 mg/day of prednisone) within 2 weeks before starting the trial. Lower-dose inhaled, topical, or replacement steroids may be acceptable in the absence of active autoimmune disease (confirm with trial site).
• People who have had gastrointestinal bleeding (bleeding in the stomach or bowel) in the 6 months before treatment, or who have a known high risk of such bleeding — for example, from severe enlarged veins in the oesophagus or stomach, active peptic ulcers, or persistently abnormal stool blood tests. People with a history of a hole in the gut wall, an abnormal connection between organs (fistula), or an abdominal abscess within 6 months before the trial are also excluded.
• People with known or inherited bleeding or clotting disorders such as haemophilia, or those currently taking full-dose blood-thinning or clot-dissolving medications (low-dose preventive aspirin use may be acceptable — confirm with trial site).
• People who have had a blood clot, stroke, mini-stroke (TIA), brain bleed, or pulmonary embolism (clot in the lungs) within the 6 months before treatment.
• People with significant or poorly controlled heart conditions, including: moderate-to-severe heart failure; weak heart pumping function; unstable chest pain (angina); a heart attack within the past year; significant irregular heart rhythms requiring treatment; or an abnormal heart electrical reading (QTc interval above certain thresholds — confirm with trial site).
• People with high blood pressure that is not well controlled by medication (blood pressure of 140/90 mmHg or higher, based on at least two readings), or a history of a hypertensive crisis or hypertensive encephalopathy (a serious sudden rise in blood pressure affecting the brain).
• People who have had a major blood vessel problem within the 6 months before treatment, such as an aortic aneurysm needing surgery or a recent arterial blood clot in a limb.
• People with serious wounds that are not healing, active skin ulcers, or bone fractures that have not healed.
• People who are unable to swallow tablets, or who have a condition that significantly affects how the gut absorbs medicines.
• People who have had a serious infection within 4 weeks before treatment, or who have been on antibiotic treatment in the 14 days before joining the trial (preventive antibiotic use may be acceptable — confirm with trial site). Also excluded are people with an unexplained fever of 38.5°C or above, or an abnormally high white blood cell count in the 7 days before the trial.
• People known to have a weakened immune system, whether from birth or due to a condition such as HIV infection.
• People who have received a live vaccine within 28 days before treatment, or who are expected to need one during the trial.
• People with any other condition that, in the trial doctor's judgement, could affect the safety of the person or the reliability of the trial results — including significant alcohol or substance use, serious psychiatric conditions, or difficult personal or family circumstances.

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