Phase 1 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 diagnosed with advanced primary liver cancer (specifically hepatocellular carcinoma, intrahepatic cholangiocarcinoma, or a combined type) where standard treatments have stopped working, were not tolerated, or no standard treatment exists. Note: in the second part of the trial, only people with advanced hepatocellular carcinoma will be enrolled.
• People who have tumour lesions in the liver and/or spread to other parts of the body that can be reached by injection using ultrasound guidance, and where the largest measurement of the injectable tumour is greater than 1.5 cm.
• People with a good general level of physical functioning, rated 0 or 1 on a standard performance scale (meaning fully active or able to carry out light activity).
• People with a life expectancy of at least 3 months.
• People whose blood, liver, kidney, and clotting function results meet specific minimum levels required by the trial (confirm with trial site for exact values).
• People who either test negative for the hepatitis B virus in their blood, or if positive, are receiving appropriate hepatitis B treatment in line with current guidelines.
• People of childbearing potential (male or female) who agree to use reliable contraception during the study and for at least 90 days after the last dose; women of childbearing potential must have a negative blood pregnancy test within 7 days of joining.
• People who have signed a written consent form agreeing to take part.

Who may not be able to join:

• People who have received chemotherapy, radiation, biological therapy, hormone therapy, targeted therapy, or immunotherapy within 4 weeks before the start of the study treatment (or within 2 weeks, or 5 half-lives — whichever is longer — for certain oral or small-molecule drugs).
• People who have had a liver artery procedure called TACE within 4 weeks before the start of study treatment.
• People who have taken part in another clinical trial involving an experimental treatment within 4 weeks before the start of study treatment.
• People who have had major surgery (not including needle biopsy) or a serious injury within 4 weeks before the start of study treatment.
• People who have received high-dose steroid medications or other immune-suppressing drugs within 14 days before the start of study treatment.
• People who still have side effects (grade 1 or higher) from previous cancer treatments, unless the trial doctor considers those effects to pose no safety risk (for example, hair loss).
• People whose cancer has spread to the brain or the lining around the brain or spinal cord.
• People who test negative for the herpes simplex virus (HSV) antibodies, meaning they have never been exposed to the virus (confirm with trial site).
• People who have had a recent flare-up of herpes simplex virus with symptoms such as cold sores, eye herpes, skin herpes, or genital herpes.
• People with other active infections that are not under control.
• People with a known history of immune deficiency or who test positive for HIV.
• People with a history of serious heart conditions, including certain irregular heart rhythms, a prolonged QTc interval on a heart tracing, a recent heart attack, heart failure, stroke, or other serious heart events within the past 6 months, significantly reduced heart pumping function, or uncontrolled high blood pressure.
• People with active or recurring autoimmune diseases (such as lupus, rheumatoid arthritis, or vasculitis); people with stable autoimmune thyroid disease may still be considered eligible (confirm with trial site).
• People who previously had serious immune-related side effects from immunotherapy (such as immune-related lung inflammation or heart muscle inflammation) that the trial doctor believes could affect safety.
• People with a known dependence on alcohol or drugs.
• People with mental health disorders or who are unlikely to be able to follow the study requirements.
• Women who are pregnant or breastfeeding.
• People with other serious unrelated health conditions that, in the trial doctor's opinion, would make participation unsafe.

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