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 been diagnosed with liver cancer (hepatocellular carcinoma) confirmed by laboratory analysis of tissue or cell samples, and who are planned for treatment at Emory University's Winship Cancer Institute or Grady Cancer Center.
• People whose cancer can be measured on imaging scans according to a standard medical measurement system called RECIST 1.1.
• People aged 18 or older.
• People who are reasonably physically active and able to care for themselves — rated at a certain level on a standard scale doctors use to measure overall health and activity (ECOG performance status of 2 or below, or Karnofsky score of 60% or above) (confirm with trial site).
• People whose recent blood test results meet minimum levels for platelets, haemoglobin, neutrophils (a type of white blood cell), and albumin (a blood protein), all tested within 28 days before starting the trial (confirm with trial site for specific values).
• People whose blood test shows a total bilirubin level below a certain threshold, tested within 28 days before starting the trial (confirm with trial site).
• People whose kidneys are functioning at an adequate level, measured by a blood test within 28 days before starting the trial (confirm with trial site).
• Women who could become pregnant must have a negative pregnancy test before starting the trial.
• Women who could become pregnant, and men participating in the trial, must agree to use reliable contraception (such as hormonal methods, barrier methods, or abstinence) before, during, and for three months after the trial ends — and must inform their treating doctor immediately if pregnancy occurs or is suspected during this time.
• People who have finished all previous cancer treatments (including radiation therapy, tumour ablation, chemoembolisation, or other liver-directed treatments) at least four weeks before starting the trial.
• People with a known heart condition or history of treatment with heart-affecting medicines who are assessed and found to be at a lower risk level on the New York Heart Association heart function scale (Class IIB or better).
• People who are expected to live for more than 12 weeks, as assessed by the investigator.
• People who are willing and able to attend scheduled visits, take study medication as planned, complete required blood tests, and follow all study procedures and restrictions — including mandatory blood sample collection.
• People who have read and signed an informed consent form showing they understand the nature of their illness, the experimental nature of the treatment, and the procedures, risks, and potential benefits involved.

Who may not be able to join:

• People with moderate-to-severe liver dysfunction, indicated by a Child-Pugh score of 7B or above (confirm with trial site).
• People with a history of blood clots in arteries or veins, or a history of bleeding in the digestive system. (People with a blood clot in the portal vein — a vein leading to the liver — may still be considered if their oncologist does not feel blood-thinning medication is needed for it.)
• People currently taking blood-thinning medicines such as warfarin, heparin products, or direct-acting anticoagulants (DOACs).
• People who have a history of peptic ulcer disease (stomach ulcers that did not bleed) and who have been taking a proton pump inhibitor (a type of stomach-protecting medicine) for fewer than 30 days before their screening visit.
• People who have received immune checkpoint inhibitor (immunotherapy) treatment within the six months before entering the trial, or who are still experiencing significant side effects (above a certain severity level) from previous liver-directed treatments given more than four weeks earlier.
• People who are currently taking part in another clinical trial or using another experimental treatment within 28 days before the first dose of the study medication.
• People with a known allergy to medicines that are chemically or biologically similar to the drugs being used in this trial.
• People for whom immune checkpoint inhibitor therapy is medically unsuitable, as determined by the investigator.
• People with serious uncontrolled health conditions, including active infection, uncontrolled heart failure, unstable chest pain, irregular heart rhythm, or mental health or social circumstances that would make it difficult to follow the study requirements.
• People who have had a serious heart or blood vessel event (such as a heart attack, arterial blood clot, or stroke-related blood clot) within three months before starting the trial; who have chest pain requiring treatment; who have symptomatic blood vessel disease in the limbs; who have severe heart failure (New York Heart Association Class 3 or 4); or who have high blood pressure that remains uncontrolled despite medication.
• People who have heart conditions that significantly raise the risk of complications with anti-inflammatory medicines (such as unstable chest pain, uncontrolled heart failure, or a recent digestive bleed), making the use of this class of drug unsuitable. (People taking a low dose of aspirin — under 325mg per day — may still be considered.)
• People currently taking other non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or naproxen.

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