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 diagnosed with hepatocellular carcinoma (liver cancer) that cannot be removed by surgery, classified as intermediate-stage (BCLC stage B, or Child-Pugh class A or B with large or multiple tumours, and no spread to blood vessels or outside the liver), who have completed a TACE procedure (a targeted liver treatment) within 4 weeks before the study starts.
• People who have recovered from the TACE procedure and its side effects, with liver enzyme and bilirubin levels back to normal or back to their levels before the procedure.
• People with a physical fitness/activity level rated as reasonably functional (ECOG performance status below 2, meaning able to carry out light activity) (confirm with trial site).
• People with adequate blood counts, including sufficient white blood cells, red blood cells, and platelets, as measured by a blood test.
• People with adequate kidney function, as shown by a kidney filtering rate above a certain level on a blood test.
• Women who could become pregnant must have a negative pregnancy test at the screening stage.
• People who agree to use an approved form of contraception from the time of signing the consent form, throughout the study, and for at least 4 weeks after finishing or leaving the study — this applies to women who could become pregnant, and to men whose female partner could become pregnant.
• People aged 20 years or older.
• People with an expected life expectancy of at least 6 months at the time of screening.
• People who are able to understand and sign a written consent form agreeing to take part.

Who may not be able to join:

• People whose liver disease is rated as Child-Pugh B8 or B9, indicating more advanced liver function decline.
• People who have received other cancer treatments — including surgery, radiotherapy, immunotherapy, or chemotherapy (other than as part of TACE) — within 4 weeks before the screening visit.
• People who have taken part in another clinical trial and received an experimental treatment within 4 weeks before the screening visit.
• People who have not yet fully recovered from the side effects of a previous experimental treatment or other cancer therapy.
• People with known cancer that has spread to the brain or the membranes around the brain or spinal cord, unless it has been treated and has been well controlled for at least 3 months.
• People with a history of another cancer, except for certain previously treated, non-invasive cancers such as early-stage cervical cancer, early-stage breast cancer (DCIS), or basal cell or squamous cell skin cancer.
• People with a history of heart attack, uncontrolled heart problems, unstable abnormal heart rhythms, or symptomatic peripheral arterial vascular disease.
• People who have tested positive for HIV.
• People with an active, uncontrolled infection (bacterial, viral, or fungal) that requires medical treatment.
• People with poor liver function, as shown by high bilirubin levels, very advanced liver disease (Child-Pugh Class C), severe blood clotting problems that cannot be corrected, or active confusion caused by liver failure.
• People with a known allergy to biological medicines or protein-based substances similar to the study drug (PTX-9908 Injection).
• Women who are pregnant or currently breastfeeding.
• People with another medical condition or situation that, in the opinion of the medical team running the trial, could interfere with the study or pose an unacceptable health risk.
• People who are unwilling or unable to follow the study procedures for any reason.
• People with a notably prolonged heart electrical interval (QTc interval above 480 milliseconds on a heart trace/ECG), which can indicate a heart rhythm risk (confirm with trial site).
• People with a history of additional risk factors for a specific serious heart rhythm problem called torsades de pointes — for example, heart failure, low potassium levels, or a family history of Long QT Syndrome.
• People currently taking other medications known to prolong the QT/QTc heart interval.

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