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 either hepatocellular carcinoma (a type of liver cancer) or biliary tract cancer (cancer of the bile ducts or gallbladder), confirmed through a tissue sample or by accepted medical diagnostic standards.
• People whose cancer has spread or cannot be removed with surgery, or whose cancer has come back or continued to grow after surgery or local treatments.
• People whose cancer has stopped responding to, or has grown back after, a previous immunotherapy treatment that targeted PD-1 or PD-L1 proteins.
• People who have had previous local treatments (such as surgery, radiation, or ablation) at least 2 weeks before starting the study, where the tumour being measured has grown by at least 25% since that treatment or was not treated by it.
• People aged 18 or older.
• People with liver cancer (Cohort A only) whose liver is still functioning at a certain level, known as Child-Pugh Score A or B7 (confirm with trial site).
• People who are generally well enough to carry out everyday activities, rated 0 or 1 on a standard medical scale called the ECOG Performance Score.
• People whose blood counts and organ function (including kidneys, liver, and bone marrow) meet the minimum levels required by the trial, without needing recent blood transfusions or growth factor support.
• People who are able and willing to use highly effective contraception for the required period before, during, and for 120 days after the trial treatment — this applies to all men and to women who could become pregnant.
• Women who could become pregnant must have a negative pregnancy blood test at the screening stage.
• People with liver cancer related to hepatitis B (HBV) who are already on antiviral treatment, or people with hepatitis C (HCV) infection whether treated or untreated, or people with liver cancer not related to a viral infection.
• People who have received a COVID-19 vaccine (vector, protein subunit, or nucleic acid type).
• People who are able to understand the study and are willing to sign a consent form and follow the study requirements.
• For people in the liver cancer group (Cohort A) who do not have a clinical diagnosis confirmed by AASLD criteria, a stored tumour tissue sample taken within the last 4 years must be available (confirm with trial site).

Who may not be able to join:

• People who have previously had a liver transplant.
• People known to be HIV positive.
• People who have received a live vaccine within 28 days before starting the study drug.
• People who have had major surgery or a serious physical injury within 28 days before starting the study drug (note: a tumour biopsy or insertion of a central line does not count as major surgery).
• People with certain serious underlying health conditions, including lung disease (such as non-infectious pneumonitis or interstitial lung disease), a serious active infection requiring intravenous treatment, significant heart disease, a history of a solid organ transplant (other than liver, which is covered separately), or conditions that make it difficult to monitor side effects.
• People who are allergic to the contrast dye used in scans and cannot be given pre-medication to manage that allergy.
• People with an active autoimmune disease, or a history of an autoimmune disease that required systemic treatment (such as immune-suppressing medications or steroids) in the past 2 years — with some exceptions such as vitiligo or childhood asthma that has fully resolved.
• People with a known history of active tuberculosis.
• People who need regular systemic steroid treatment at doses above the equivalent of 10mg of prednisone per day, or other immune-suppressing medications, within 14 days before starting the study.
• People who previously stopped an immunotherapy (checkpoint inhibitor) treatment because of a serious immune-related side effect rated Grade 2 (serious type) or Grade 3 or higher.
• People who have had a severe allergic reaction (Grade 3 or higher) to monoclonal antibody treatments.
• People who have had another cancer in the past 2 years that required systemic treatment — with some exceptions for certain easily treated skin cancers or early-stage cancers that appear to have been fully treated.
• People who are in prison or are involuntarily held in a facility.
• People with active or worsening brain metastases (cancer that has spread to the brain), including those with carcinomatous meningitis, or those whose brain lesions need immediate treatment.
• People who are pregnant or breastfeeding.
• People with known psychiatric conditions or substance use disorders that would make it difficult to participate in the trial.
• People with significant dementia or other mental conditions that would prevent them from being able to give informed consent.
• People who have taken another experimental drug within 28 days or 5 half-lives (whichever is longer) before starting this study.
• People with a known allergy to recombinant proteins or to any ingredient in the study drugs.
• People with a type of liver cancer called fibrolamellar HCC.

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