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 are able and willing to give written consent to participate.
• Adults aged 18 or older, of any sex.
• People who are relatively well and able to carry out daily activities, based on a standard cancer performance scale (ECOG score of 0 or 1).
• People in Cohort 2: those with confirmed advanced, metastatic, or inoperable liver cancer (HCC) whose disease has continued to grow after at least two standard treatment regimens approved by the FDA, including immunotherapy or anti-blood-vessel-growth therapy as first treatment, and at least one other approved drug as second treatment.
• People in Cohort 3: those with confirmed advanced, metastatic, or inoperable bile duct cancer (ICC) whose disease has continued to grow after chemotherapy as the first treatment. Those with a specific gene change called IDH1 must have received a targeted therapy for that mutation, and those with a specific tumour marker called MSI-H must have received a type of immunotherapy.
• People in Cohorts 1 and 4: those who meet the criteria for either Cohort 2 or Cohort 3 above.
• People in Cohorts 1 and 2: those whose liver is functioning at a level classed as Child-Pugh A or B (a standard measure of liver health).
• People who have at least one tumour that can be measured using standard imaging guidelines (RECIST 1.1).
• People who have at least one tumour that can be injected directly — measuring at least 15mm at its longest point — including deeper tumours in the liver or abdomen that a doctor judges can be safely injected using imaging guidance.

Who may not be able to join:

• People who have taken part in another clinical trial of an experimental treatment within the last 4 weeks before starting this trial (individual cases may be reviewed).
• People whose tumours to be injected are located near mucous membranes, airways, major blood vessels, or the spinal cord, where swelling or tissue breakdown could cause serious problems.
• People with a primary brain or spinal cord cancer (such as glioma), or whose cancer is currently active and growing in the brain or nervous system. People who have had brain metastases that were treated may be considered if there is no sign of progression for at least 4 weeks after brain-directed treatment, confirmed by imaging, and they have been off steroids for at least 2 weeks before starting (confirm with trial site).
• People who have had major surgery within 14 days before starting the trial.
• People who have had a serious infection within 28 days before screening, or who were treated with antibiotics within 14 days before signing the consent form.
• People with a life-threatening illness unrelated to their cancer.
• People with an active herpes infection.
• People who have taken antiviral medicines within 14 days before starting the trial.
• People with uncontrolled heart failure.
• People who have tested positive for HIV or syphilis.
• People with an active hepatitis B or hepatitis C infection that is currently being treated with antiviral medication, if the treating doctor determines this could interfere with the trial treatment.
• People who have used the antiviral drugs ganciclovir or acyclovir within 14 days before starting the trial.
• People who have needed immune-suppressing medications — including corticosteroids at doses above the equivalent of 10mg of prednisone per day — within 14 days before starting. Low-dose steroids (up to 10mg prednisone equivalent) used for breathing or skin conditions, or as hormone replacement, may be acceptable if there is no active autoimmune disease (confirm with trial site).
• People who have been on blood-thinning (anticoagulant) medications within 14 days before starting, or whose blood clotting level (INR) is above 1.5 times the upper limit of the normal range.
• People whose tumour to be injected has previously been treated with radiation therapy, unless imaging shows the tumour has continued to grow since that treatment was completed.

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