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 are able to understand the study and are willing to give their consent and follow the study rules and procedures.
• People who are 18 years of age or older at the time of giving consent.
• People who have been diagnosed with liver cancer (HCC) that has spread or cannot be surgically removed, confirmed either through a tissue sample or specific imaging results. People without liver scarring (cirrhosis) must have tissue confirmation.
• People in Groups A and B who are willing to provide a fresh tumour tissue sample before joining the study, taken after their cancer got worse on a previous treatment. People in Group C do not need a biopsy.
• People who have measurable areas of cancer according to standard measurement guidelines (RECIST v1.1). People who had previous local treatments may still be eligible if the area being measured was not treated locally, or if it has since grown back according to those same guidelines.
• People who are able to swallow tablets.
• People whose general physical health and ability to carry out daily activities is rated as 0 or 1 on a standard medical scale (ECOG), meaning they are fully active or have only minor limitations.
• People whose blood and organ function test results at screening meet all of the following levels (confirm with trial site for exact values):
  • Enough white blood cells (neutrophils) without needing growth factor support.
  • Enough lymphocytes (another type of immune cell).
  • Enough platelets without needing a transfusion.
  • Haemoglobin at an adequate level (transfusions are allowed to reach this level).
  • Adequate protein (albumin) levels in the blood.
  • Liver enzyme levels within acceptable limits.
  • Bilirubin (a liver waste product) within acceptable limits.
  • Adequate kidney function, measured by a calculation or a 24-hour urine test.
• People whose blood clotting test results are within acceptable limits, except for those already on blood-thinning medication.
• People whose liver disease is rated as Child-Pugh class A or B7 (a measure of liver function) within 7 days before joining.
• Women who could become pregnant must have a negative pregnancy test at screening, must not be breastfeeding, and must agree to use a highly effective form of contraception during the study and for at least 30 days after the last dose.
• Men must agree to use a condom for at least 30 days after the last dose (even if vasectomised), must not donate sperm for 30 days after the last dose, and — unless surgically sterile — must use two forms of contraception with a female partner who could become pregnant for at least 30 days after the last dose.

Group A only:

• People in Group A must have had their cancer get measurably worse during or after up to three previous systemic (whole-body) cancer treatments.

Group B only:

• People in Group B must have had their cancer get measurably worse during or after at least two treatment cycles of a first-line immunotherapy drug (anti-PD-1 or anti-PD-L1), used alone or in combination, and must not have had more than one prior line of systemic treatment.
• People in Group B must agree to use contraception as described above for at least 4 months after the last dose of pembrolizumab.

Group C only:

• People in Group C must not have previously received any systemic (whole-body) treatment for their advanced or unresectable liver cancer.
• People in Group C must have had a stomach and upper digestive tract examination (gastroduodenoscopy) within 6 months before starting bevacizumab therapy.
• People in Group C must agree to use contraception as described above for at least 5 months after the last dose of atezolizumab and at least 6 months after the last dose of bevacizumab.

Who may not be able to join:

• People who are pregnant or breastfeeding.
• People whose liver cancer is of a specific rare type, including fibrolamellar HCC, sarcomatoid HCC, or a mixed type involving the bile ducts.
• People with a history of cancer that has spread to the lining around the brain and spinal cord (leptomeningeal disease).
• People who have previously received a specific type of drug called a STAT inhibitor for their current cancer.
• People who have received standard cancer treatments (such as chemotherapy, immunotherapy, or other anti-cancer therapies) within 28 days (or 5 half-lives, whichever is shorter) before the first day of treatment in this study — or within 6 weeks for certain specific drugs.
• People who have received any experimental treatment within 28 days (or 5 half-lives, whichever is shorter) before the first day of treatment.
• People who have had extensive radiation to the bone marrow, or a bone marrow or stem cell transplant within the past 5 years.
• People who are currently taking herbal supplements such as St. John's wort, ginseng, ginkgo biloba, or similar products. These must be stopped at least 7 days before the first dose.
• People who have not fully recovered from COVID-19 for at least 2 weeks before the start of treatment.
• People who are still experiencing significant side effects from a previous cancer treatment (hair loss is an exception), unless those effects have returned to baseline or are very mild.
• People who have had major surgery within 3 weeks before starting treatment, or who have not recovered from major surgical side effects.
• People with serious heart problems, including unstable chest pain, severe heart failure, a heart attack in the past 12 months, certain heart rhythm problems, an abnormal heart electrical reading (QTc prolongation above specified limits), a pacemaker, a known inherited heart condition, or poor heart pumping function on a scan.
• People who regularly need drainage procedures for fluid build-up around the lungs, heart, or abdomen (once a month or more often). People with a permanent drain in place are allowed.
• People who have had a stroke or brain blood vessel event in the past 2 years.
• People with a history of confusion or brain impairment caused by liver disease (hepatic encephalopathy).
• People with uncontrolled or symptomatic high calcium levels in the blood.
• People with a significant bleeding disorder or blood clotting problem (when not on prescribed blood thinners).
• People who have had a severe allergic reaction to drugs chemically similar to the study drug TTI-101.
• People with active cancer spread to the brain, unless the brain disease has been stable on imaging for at least 1 month, with no brain swelling and no need for steroids or anti-seizure medication.
• People who have difficulty swallowing pills, a condition affecting the gut's ability to absorb medication, or other chronic gut conditions that could interfere with taking or absorbing the study drug.
• People with a known history of HIV infection.
• People with chronic hepatitis B infection, unless their virus levels are below a set limit and they are on stable antiviral treatment. People with both hepatitis B and hepatitis C are excluded unless hepatitis C is no longer detectable.
• People who have had another cancer within the past 3 years, except for certain low-risk cancers with a very low chance of spreading or causing death (such as early-stage cervical, skin, prostate, or uterine cancers — confirm with trial site).
• People with other serious uncontrolled medical conditions that the trial doctor considers would make participation unsafe, such as chronic pancreatitis, active uncontrolled infections (including COVID-19), or sepsis.
• People who are unable to understand or follow the study instructions.

Group B only (additional exclusions):

• People who stopped their previous anti-PD-1 or anti-PD-L1 immunotherapy for any reason other than their cancer getting worse.

Group C only (additional exclusions):

• People with poorly controlled high blood pressure (systolic 150 mmHg or higher and/or diastolic 100 mmHg or higher), based on multiple readings across at least two separate sessions.
• People who have previously received systemic chemotherapy for their advanced or unresectable liver cancer. However, people who received chemotherapy before or after surgery (neo-adjuvant or adjuvant) may be eligible if it was completed at least 6 months before the first study dose.
• People with untreated or incompletely treated swollen veins in the oesophagus or stomach (varices) that are at high risk of bleeding, or who have had a bleeding event from these veins in the 6 months before starting treatment.
• People with protein levels in their urine of 2+ or higher on a urine test at screening, unless a 24-hour urine collection shows less than 1 gram of protein.
• People who have taken high-dose aspirin (more than 325 mg per day) or certain blood-thinning drugs (such as clopidogrel or dipyridamole) within 10 days before the first study dose.
• People on full-dose blood-thinning medication (oral or injected) within 10 days before the start of treatment. Low-dose preventive blood thinners may be allowed (confirm with trial site).
• People who have had a core biopsy or minor surgical procedure (other than placing a vascular access device) within 3 days before the first dose of bevacizumab.
• People with a history of a hole (perforation) in the stomach or intestines, or signs of free air in the abdomen not explained by a recent procedure.
• People whose cancer has spread to involve major airways or large blood vessels (involvement of certain liver veins does not automatically exclude someone — confirm with trial site).
• People who have experienced, within the 6 months before joining, a serious blood clot in an artery (such as a heart attack, stroke, or mini-stroke), heart failure, coughing up blood, or a blood clot in the lungs.
• People who have experienced an abnormal passage (fistula) between organs or tissues.

Groups B and C only (additional exclusions):

• People who have received a live or weakened (attenuated) vaccine within 4 weeks before starting treatment, or who expect to need one during pembrolizumab treatment or within 5 months after the last dose.
• People with an active or past immune system disorder (such as lupus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, or similar conditions). Some exceptions apply for well-controlled thyroid disease, Type 1 diabetes, or mild skin conditions — confirm with trial site.
• People with a history of certain lung scarring or inflammatory lung conditions, or signs of active lung inflammation on a CT scan at screening.
• People who have taken immune-suppressing medications (such as steroids, methotrexate, or similar drugs) within 2 weeks before starting treatment. Low-dose steroids or short-course steroids for contrast allergy may be allowed (confirm with trial site).
• People with active tuberculosis.
• People who have had a serious infection within 4 weeks before starting treatment, including hospitalisation for infection, bacteria in the bloodstream, or severe pneumonia.
• People who have taken antibiotic treatment (by mouth or by drip) within 2 weeks before starting treatment. People taking preventive antibiotics may still be eligible (confirm with trial site).
• People who have previously had a transplant of donor stem cells or a solid organ (such as a kidney or liver).
• People with a history of a severe allergic (anaphylactic) reaction to certain types of antibody-based drugs (chimeric or humanised antibodies or fusion proteins).

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