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 aged 18 years or older.
• People with liver cancer (hepatocellular carcinoma, or HCC) confirmed by tissue testing and/or medical imaging (this applies to Group 2 of the study).
• People with a type of bile duct cancer found inside the liver (intrahepatic cholangiocarcinoma, or iCCA) confirmed by tissue testing (this applies to Group 3 of the study).
• People whose cancer cannot be surgically removed.
• People whose cancer can be measured or assessed on scans.
• People whose tumours can be treated with high-dose targeted radiation (EBRT) without causing unacceptable harm to surrounding healthy tissue.
• People whose tumours can be reached using an ultrasound-guided injection approach.
• People who have no signs of cancer spread outside the liver (excluding a specific type of blood clot called tumour thrombus), confirmed by CT or MRI scan.
• People who are considered a good candidate for standard high-dose targeted radiation therapy by the treating doctor.
• People who are generally well and able to carry out daily activities with little to no restriction (assessed using a standard medical scale called ECOG performance status 0 or 1).
• People in the HCC group (Group 2) whose recent blood and urine test results meet specific minimum levels for blood cell counts, liver function, kidney function, and clotting (tests must be done within 15 days before joining).
• People in the iCCA group (Group 3) whose recent blood test results meet specific minimum levels for blood cell counts, liver function, kidney function, and clotting (tests must be done within 15 days before joining).
• People who are able and willing to sign a written consent form.
• People who are willing to return to the enrolling site for follow-up visits during the active monitoring phase of the study.
• People who are willing to provide blood and tissue samples for research purposes.

Who may not be able to join:

• People who are pregnant or currently breastfeeding.
• People who are capable of becoming pregnant and are not willing to use highly effective contraception during heterosexual intercourse throughout the study and for 5 months after the last dose of study treatment.
• People with serious other health conditions that, in the treating doctor's judgement, would make participation unsafe or interfere with properly assessing the treatment.
• People with a weakened immune system, or people known to be HIV positive — though people living with HIV who are stable on anti-HIV medication, have an adequate immune cell count (CD4+ T cells ≥ 200/uL), and have an undetectable viral load may still be considered eligible (confirm with trial site).
• People with uncontrolled ongoing illness, including active infections requiring treatment, a serious infection within the past 4 weeks, significant heart disease, or mental health or social circumstances (such as substance use) that would make it difficult to follow the study requirements.
• People currently receiving another experimental treatment for their cancer.
• People who have had another active cancer within the past year that the treating doctor believes could interfere with this trial's treatment or results.
• People who have had major surgery within the past 4 weeks (except for diagnostic procedures or surgical preparation for radiation), or who are expected to need major surgery during the study.
• People with a history of severe allergic reactions to the pneumococcal vaccine or any of its ingredients, including diphtheria toxoid.
• People with an active or past autoimmune disease or immune system deficiency (such as lupus, rheumatoid arthritis, multiple sclerosis, Crohn's disease, and others) — though some exceptions apply for certain well-controlled conditions such as hypothyroidism, type 1 diabetes, and mild skin conditions (confirm with trial site).
• People who require blood-thinning medication that cannot be safely stopped before the injection procedure.
• People who have taken corticosteroid medications (including oral, injected, or inhaled forms) within the past 2 weeks — though some exceptions apply for low-dose or short-term use in specific circumstances (confirm with trial site).
• People who have had a heart attack within the past 6 months, or who have heart failure requiring ongoing treatment for life-threatening heart rhythm problems.
• People with moderate or severe liver scarring (cirrhosis) rated as Child-Pugh class B or C.
• People who have previously received immune-based therapies such as checkpoint inhibitors (for example, treatments targeting PD-1, PD-L1, or CTLA-4), or prior dendritic cell therapy.
• People who have previously had radiation treatment to the liver, including a type called radioembolisation.
• People in the HCC group (Group 2) with the most advanced stage of liver cancer by a specific staging system (BCLC stage D).
• People in the HCC group (Group 2) with untreated high-risk swollen veins in the oesophagus or stomach (gastroesophageal varices).
• People with active tuberculosis.
• People who have been treated with antibiotic tablets or infusions within the past 2 weeks — though people taking preventive (prophylactic) antibiotics may still be eligible (confirm with trial site).
• People who have previously had a bone marrow transplant or received a donated organ.
• People who have received a live vaccine within the past 4 weeks.

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