Phase 2 Oesophageal 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 a confirmed diagnosis of Barrett's oesophagus (a condition affecting the lining of the food pipe), with no abnormal cell changes, uncertain cell changes, or low-level abnormal cell changes, covering at least 2 cm of the food pipe.
• People whose tissue samples show a sufficient amount of the specific type of cell changes associated with Barrett's oesophagus (at least 50% in at least one sample).
• People who have been taking proton pump inhibitor (acid-reducing) medication for at least 28 days before joining.
• People aged 18 or older.
• People who are generally well enough to carry out normal daily activities with little or no difficulty (confirm with trial site for exact fitness level required).
• People whose blood test results fall within acceptable ranges for red blood cells, white blood cells, and platelets (confirm with trial site for exact values).
• People whose kidney function test results are within an acceptable range (confirm with trial site).
• People whose liver function test results — including liver enzymes and bilirubin — are within acceptable ranges (confirm with trial site).
• People who are willing and able to use reliable contraception (such as hormonal methods, barrier methods, or abstinence) before, during, and for at least 6 months after the study treatment, because the effects of the study drug on an unborn baby are not yet known.
• People who are able to understand the study procedures and risks, and who are willing to sign a consent form. Non-English speakers may also be eligible, even if they cannot complete some quality-of-life questionnaires.
• People who are willing to have an HIV test if one has not been done in the past 6 months.
• People who are willing to have hepatitis B and C tests if these have not been done in the past 6 months.
• People who are willing to keep alcohol intake moderate (no more than 1 drink per day for women, no more than 2 drinks per day for men).
• People who have had no signs of active or returning invasive cancer for at least 6 months before screening, and who are at least 6 months past any previous cancer treatment.

Who may not be able to join:

• People who have previously had ablative treatments (procedures that destroy tissue, such as radiofrequency ablation, cryotherapy, or argon plasma coagulation) in the affected area of the food pipe.
• People who have previously used the study drug (obeticholic acid / OCA).
• People who have a history of, or currently have, high-grade abnormal cell changes or cancer found on a previous scope examination of the food pipe.
• People who have a skin condition that causes severe itching.
• People with active or known chronic liver disease, including cirrhosis, a particular type of liver inflammation with scarring (NASH with fibrosis or cirrhosis), primary sclerosing cholangitis, or a bile duct condition called biliary atresia.
• People with acute gallbladder inflammation (a condition causing pain in the upper right abdomen, fever, and elevated white blood cell count).
• People with a history of pancreas inflammation or pancreas problems.
• People whose liver ultrasound results show a combination of fat in the liver and a stiffness reading above a certain level (confirm with trial site for exact threshold).
• People with high cholesterol or high blood fats that are not well managed with medication or diet.
• People with severe, ongoing, or uncontrolled conditions affecting the kidneys, urinary system, liver, blood, hormone system, heart, blood vessels, lungs, joints, nervous system, mental health, or metabolism.
• People who have a known allergy or intolerance to the study drug or similar substances.
• People with any serious or unstable medical or psychiatric condition that could affect their safety or ability to participate fully.
• People with uncontrolled illness, including active infection, heart failure, unstable chest pain, irregular heartbeat, or mental health or personal circumstances that would make it difficult to follow study requirements.
• People with active, untreated hepatitis C or hepatitis B infection.
• People living with HIV may not be able to join unless certain conditions are met, including a sufficiently high immune cell count, an undetectable level of virus in the blood, and being on appropriate HIV treatment without known interactions with the study drug (confirm with trial site).
• People currently taking certain medications — including some cholesterol-binding drugs, specific muscle relaxants, blood thinners (such as warfarin), certain psychiatric medications, asthma medications, or drugs that can affect the liver — may not be able to join unless they are willing and able to stop these medications at least a set number of days before starting the study (confirm with trial site for the full list and required timeframes).
• People who are pregnant, breastfeeding, or who are capable of becoming pregnant but are unwilling to use reliable contraception.
• People who are currently taking part in another clinical trial involving an investigational treatment.

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