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 have been diagnosed with intrahepatic cholangiocarcinoma (a type of bile duct cancer that starts inside the liver), confirmed by a tissue or cell sample, and whose cancer appears removable by surgery based on imaging scans.
• People whose cancer can be measured on a scan or physical exam, with at least one area of cancer measuring 1 cm or larger.
• People who a specialist liver and bile duct surgeon has determined are fit enough to safely have surgery.
• People whose cancer is considered "high-risk" based on at least one of the following: the tumour is larger than 5 cm; there are multiple tumour spots or satellite tumours within the same part of the liver; the cancer has grown into nearby blood vessels; nearby lymph nodes are suspected or confirmed to contain cancer; or a blood marker called CA 19-9 is above 200 U/mL.
• People who have not previously received any treatment for this cancer.
• People aged 18 or older (children are not eligible because safety data for this age group is not yet available).
• People who weigh more than 30 kg.
• People who are generally able to carry out everyday activities, with little or no limitation (confirm with trial site for exact fitness level required).
• People whose blood test results meet minimum levels for white blood cells, red blood cells, neutrophils (infection-fighting cells), and platelets (confirm with trial site for specific values).
• People with little or no nerve damage symptoms.
• People whose blood tests show the liver and kidneys are functioning adequately (confirm with trial site for specific values).
• Women who are post-menopausal, or pre-menopausal women who have a negative pregnancy test before starting the trial.
• People with a life expectancy of at least 12 weeks.
• People living with HIV who are on effective treatment and whose virus levels are undetectable within the past 6 months.
• People with a history of hepatitis B who are on appropriate treatment and whose virus levels are undetectable.
• People with a history of hepatitis C who have been successfully treated and cured, or who are currently being treated and have undetectable virus levels.
• People who previously had brain metastases (cancer spread to the brain) that were treated, as long as follow-up scans show no sign of the cancer growing back in the brain.
• People who have had or currently have another type of cancer, as long as that cancer or its treatment is unlikely to interfere with this trial (the trial team would review and approve these situations individually).
• People with a history of heart disease or prior treatment with heart-affecting medicines, provided their heart function meets a certain minimum level as assessed by a doctor (confirm with trial site for exact classification required).
• People who are able to understand the study and are willing to sign a consent form (a legal representative may sign on someone's behalf if needed).

Who may not be able to join:

• People who have not yet recovered from significant side effects of a previous treatment.
• People who have had a major surgical procedure within the 14 days before starting the trial medication (minor procedures such as placement of a bile duct stent are generally acceptable).
• People who have used immune-suppressing medications within the 14 days before starting the trial medication, with some exceptions such as low-dose steroid creams, nasal sprays, inhalers, or very low-dose oral steroids.
• People who have received a live vaccine within the 30 days before starting the trial medication.
• People who are currently participating in another clinical trial involving an experimental treatment.
• People who have had a serious allergic reaction to durvalumab, gemcitabine, cisplatin, or similar medicines used in this trial.
• People with other serious uncontrolled illnesses or conditions that would make participation unsafe.
• People who are pregnant or breastfeeding, as the trial medicines may harm an unborn baby or infant. All participants of childbearing potential and their partners are required to use effective contraception throughout the trial and for 6 months after the last dose of durvalumab.
• People with active or previously documented autoimmune or inflammatory conditions (such as lupus, Crohn's disease, rheumatoid arthritis, and similar conditions), with some exceptions including stable thyroid conditions managed with medication, vitiligo, hair loss conditions, mild skin conditions not requiring systemic treatment, coeliac disease managed by diet alone, or conditions that have not been active in the past 5 years (the last group would require discussion with the study doctor).
• People with an active infection such as tuberculosis, active hepatitis B, or active hepatitis C.
• People who have previously received an organ transplant from another person.
• People who have another cancer whose history or treatment could affect the safety or results of this trial.

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