Phase 2 Pulmonary Hypertension 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 informed consent to participate in the study
• Adults between 18 and 75 years of age (male or female)
• People whose cancer has been confirmed by laboratory testing (tissue or cell sample) to be intrahepatic cholangiocarcinoma (ICC), a type of bile duct cancer that starts inside the liver
• People whose cancer cannot be removed by surgery, or whose cancer has come back or progressed after previous surgery or local treatment
• People who have not had any systemic (whole-body) treatment for advanced ICC — with an exception for those whose cancer returned more than 6 months after completing chemotherapy given after a complete surgical removal; any local treatments (such as surgery, radiation, or procedures targeting the liver) must have been finished at least 4 weeks before the study's baseline scans, and any side effects from those treatments must have largely resolved
• People who have at least one measurable area of cancer that meets specific size requirements on imaging scans
• People whose liver function is rated as "Child-Pugh Grade A," meaning the liver is still functioning reasonably well (confirm with trial site)
• People with a performance status score of 0 or 1 on the ECOG scale, meaning they are either fully active or have only minor limitations in physical activity (confirm with trial site)
• People with a life expectancy of at least 12 weeks
• People whose heart, lungs, liver, kidneys, blood, and bone marrow are functioning adequately, and who do not have an immune deficiency condition
• People with an active hepatitis B infection, provided their hepatitis B virus levels are below a specified threshold and they are willing to take antiviral medication throughout the study
• Women who could become pregnant must agree to use reliable contraception or abstain from heterosexual intercourse from the time of signing consent until at least 120 days after the last dose of study medication, and must have a negative pregnancy blood test within 7 days before starting treatment; women who are currently breastfeeding are not eligible
• Men with female partners who could become pregnant must agree to use reliable contraception or abstain from heterosexual intercourse from signing consent until at least 120 days after the last dose, and must agree not to donate sperm during this time; men whose partners are already pregnant must use a condom

Who may not be able to join:

• People whose liver cancer has been identified as a different type, such as hepatocellular carcinoma, combined hepatocellular and bile duct cancer, sarcomatoid hepatocellular carcinoma, or fibrolamellar carcinoma
• People who have had, or currently have, another active cancer within the past 5 years — though some fully treated, localised cancers (such as certain skin cancers, early-stage bladder cancer, or cancer in situ of the cervix, prostate, or breast) may still be eligible
• People who have had, or are planning to have, an organ transplant or bone marrow transplant from a donor
• People who have taken part in another clinical trial and received an experimental treatment within 28 days before starting this study
• People who have previously been treated with certain immune-based cancer therapies known as immune checkpoint inhibitors (such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 drugs)
• People with significant fluid build-up in the abdomen causing symptoms that require draining, or uncontrolled fluid around the lungs or heart
• People who have had gastrointestinal (digestive tract) bleeding in the past 6 months, or who are at clear risk of such bleeding
• People who have had an abnormal opening (fistula), perforation, or abscess in the abdominal area within the past 6 months
• People with a known bleeding or clotting disorder (such as haemophilia), or who are currently taking full-dose blood-thinning or clot-dissolving medications (low-dose preventive use of aspirin or low-molecular-weight heparin may be allowed)
• People currently taking high-dose aspirin (above 325 mg per day) or certain other blood-thinning medications such as clopidogrel or dipyridamole within 10 days before starting the study
• People who have had a blood clot, stroke, mini-stroke (TIA), or pulmonary embolism within the past 6 months
• People with heart conditions or symptoms that are not well controlled
• People with high blood pressure that cannot be adequately controlled with medication, or who have previously had a hypertensive crisis or hypertensive encephalopathy (a serious complication of very high blood pressure)
• People who have had major blood vessel surgery or a serious vascular event within the past 6 months, or who have wounds, ulcers, or fractures that have not healed; people who have had major surgery within 4 weeks before starting the study, or who have major surgery planned during the study period
• People with unexplained air in the abdominal cavity (not explained by a recent procedure or surgery)
• People with cancer that has spread to the brain or central nervous system, or cancer that is affecting major blood vessels or airways in specific ways described in the criteria
• People with a history of brain dysfunction caused by liver disease (hepatic encephalopathy); people with current or past lung inflammation conditions (such as interstitial lung disease or pulmonary fibrosis) that required steroid treatment; people with active tuberculosis
• People with an active autoimmune disease, or a history of autoimmune disease that may return — though some conditions may still be eligible (confirm with trial site), such as controlled type 1 diabetes, stable skin conditions not requiring systemic treatment, or childhood asthma that fully resolved
• People who have taken immune-suppressing medications, or systemic steroids at doses above a specified level, within 14 days before starting the study
• People with a known allergy or serious sensitivity to any ingredient in the study drugs
• People who have had a severe infection within 4 weeks before starting the study, including infections requiring hospitalisation; people who have taken antibiotic treatment by mouth or intravenously within 2 weeks before starting (preventive antibiotic use may be allowed — confirm with trial site)
• People with a known immune deficiency condition, such as HIV infection
• People with both hepatitis B and hepatitis C infections at the same time
• People who have received a live (attenuated) vaccine within 28 days before starting the study, or who are expected to need one during the study or within 60 days after the last dose of the study drug Adebrelimab
• People with other significant health, mental health, social, or lifestyle factors that the study doctors believe could affect their safety or the reliability of the study results

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