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 who have signed a written consent form agreeing to participate in the study.
• People who are 18 years of age or older at the time of joining the study.
• People who have been diagnosed with liver cancer (hepatocellular carcinoma) that cannot be surgically removed or has spread to other parts of the body, confirmed through a tissue or cell sample.
• People whose liver cancer has gotten worse or who could not tolerate one previous round of systemic (whole-body) treatment for advanced liver cancer.
• People who did not respond to, or could not tolerate, a previous treatment such as oxaliplatin-based chemotherapy, targeted therapies like sorafenib or lenvatinib, or immunotherapy drugs that target PD-1 or PD-L1.
• People who have at least one area of cancer that can be measured on a CT or MRI scan, according to standard measurement guidelines (RECIST criteria).
• People whose general physical condition is rated 0, 1, or 2 on the ECOG performance scale, meaning they are able to carry out at least some daily activities (confirm with trial site if unsure how this applies).
• People who are expected to live for at least 12 weeks.
• People whose blood counts, liver function, and kidney function meet specific levels set by the trial — including adequate white blood cells, platelets, liver enzymes, kidney function markers, and protein levels (confirm with trial site for exact values).
• Women who could become pregnant must have a negative pregnancy test (urine or blood) within 7 days before starting the trial.
• People who are willing and able to follow all the trial requirements, including attending scheduled visits, undergoing treatment, using contraception as required, and completing follow-up appointments.

Who may not be able to join:

• People with a history of heart disease, or who have had a clinically significant gastrointestinal (digestive tract) bleed within the past 4 weeks.
• People who have had a blood clot or stroke — including mini-strokes (transient ischaemic attacks), deep vein thrombosis, or a blood clot in the lungs — within the 6 months before starting the trial (with one specific exception relating to a type of portal vein clot — confirm with trial site).
• People who have previously had a treatment called cryoablation (freezing of tumour tissue).
• People who have had radiofrequency ablation (RFA) or tumour removal surgery less than 4 weeks before the planned trial start date.
• People who have had radiotherapy less than 4 weeks before the planned trial start date.
• People who have had major surgery within 4 weeks before the planned trial start, or who have not yet fully recovered from major surgery.
• People who have a second type of cancer, unless it is a well-treated form of skin cancer or very early-stage cervical cancer.
• People with a weakened immune system, including those who are known to be HIV-positive.
• People who have taken part in another clinical trial with an experimental treatment in the last 30 days before joining (or longer, depending on the previous trial drug — confirm with trial site).
• People with certain other health conditions or complications that the trial doctor believes could interfere with the study, including:
  • A history of interstitial lung disease (scarring or inflammation of the lungs).
  • Being infected with both Hepatitis B and Hepatitis C at the same time.
  • Known acute or chronic pancreatitis (inflammation of the pancreas).
  • Active tuberculosis.
  • Any other active serious infection (viral, fungal, or bacterial) currently needing treatment with systemic (whole-body) medication.
  • A history of receiving a transplanted organ or tissue from another person.
  • A diagnosis of immune system deficiency, or currently receiving steroid tablets or other immune-suppressing medications within 7 days before the first dose of the study drug Tislelizumab.
  • An active autoimmune disease (where the immune system attacks the body) that has required treatment within the past 3 months, or a history of a severe autoimmune condition — though some milder conditions such as vitiligo, stable low thyroid function, type 1 diabetes, or resolved childhood asthma may be exceptions (confirm with trial site).
  • Having received a live vaccine within 30 days before starting Tislelizumab, or during the trial.
  • A history or current signs of cancer that has spread to the brain or central nervous system — though people who have completed local treatment, have no symptoms, and have not needed steroids for 6 weeks before starting may be exceptions (confirm with trial site).
• People taking medications known to interfere with the drugs being used in this trial.
• People currently receiving any other effective cancer treatment not specified in the trial protocol.
• People who have received any other experimental treatment within 28 days of joining the study.
• Women who are pregnant or breastfeeding, or people of reproductive age (male or female) who are not using an effective form of contraception (less than 1% failure rate per year). Acceptable methods include implants, injectable contraceptives, combined oral contraceptives, hormonal intrauterine devices, sexual abstinence, or a partner who has had a vasectomy. Women who could become pregnant must have a negative blood pregnancy test at the screening stage.
• People with a significant history of not following medical instructions, or who are unable to give reliable informed consent.

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