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 or older who have been diagnosed with liver cancer (hepatocellular carcinoma), confirmed either by a tissue sample or through established clinical guidelines.
• People whose liver cancer is advanced, has spread to other parts of the body, or cannot be surgically removed, and for whom curative treatment is not possible.
• People whose liver cancer got worse while receiving a specific first-line treatment combining atezolizumab and bevacizumab — this trial is for second-line patients only.
• People who have signed a consent form within 28 days before being randomly assigned to a treatment group.
• People who are willing to return to the enrolling institution for follow-up visits during the active treatment and monitoring phase.
• 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 whose liver function falls within a specific category called Child-Pugh class A (a measure of how well the liver is working).
• People who have had their hepatitis B and C status tested and documented, and — if hepatitis B is active — whose virus levels are below a set threshold, who have been on hepatitis B treatment for at least 14 days before joining, and who are willing to continue that treatment throughout the study.
• People who have at least one measurable tumour that has not been treated locally, or where a previously locally treated tumour has since grown again in a measurable way.
• People willing to provide blood samples for research purposes.
• People willing to provide tissue samples for research purposes (this applies only to the first 10 patients per treatment group at Mayo Clinic Rochester and Mayo Clinic Arizona).
• People who consent to sharing stored tumour tissue if it is available — those without stored tissue are not excluded.
• People whose recent blood test results (taken within 28 days before joining) meet specific levels for white blood cells, platelets, haemoglobin, liver enzymes, bilirubin, albumin, kidney function, and blood clotting (confirm exact thresholds with the trial site).
• People who have had a negative pregnancy test within 14 days before joining (required for women who could become pregnant).
• People who have recovered from significant side effects of previous treatments, down to a mild or no-symptom level, before joining — hair loss and mild nerve tingling in hands or feet are exceptions.
• People who agree to use two forms of approved contraception during the study and for at least 5 months after the last dose of study medication; people whose partners could become pregnant must also use condoms during and for 5 months after treatment, even if they have had a vasectomy.
• People who are able to swallow and take oral (by mouth) medications.

Who may not be able to join:

• People diagnosed with specific rare subtypes of liver cancer, including fibrolamellar carcinoma, sarcomatoid carcinoma, or mixed hepatocellular cholangiocarcinoma.
• People who have previously received a multi-kinase inhibitor medicine (such as cabozantinib, lenvatinib, sorafenib, or regorafenib) for advanced liver cancer — note that use of these medicines as an early preventive treatment or as part of a local procedure, completed at least 6 months before joining, may be allowed (confirm with trial site).
• People who have had major surgery within 4 weeks, or minor surgery within 7 days, before joining, or who have unresolved complications from a recent surgery.
• People who have received any anti-cancer treatment within 2 weeks before joining.
• People who have received radiation therapy within 4 weeks (or 1 week for palliative bone or pain-related radiation), or certain radioactive treatments within 6 weeks, before joining.
• People who have received another experimental treatment within 28 days before joining.
• People with known cancer that has spread to the brain or to the lining surrounding the brain and spinal cord.
• People with a known combined infection of both hepatitis B and hepatitis C.
• People with an active or past autoimmune disease or immune deficiency condition — though some exceptions apply, including well-controlled thyroid conditions on hormone replacement, well-controlled type 1 diabetes on insulin, and mild stable skin conditions such as eczema, psoriasis, or vitiligo that meet specific requirements (confirm with trial site).
• People with a history of certain lung conditions, including idiopathic pulmonary fibrosis, organising pneumonia, drug-induced lung inflammation, or unexplained lung inflammation — or those who show signs of active lung inflammation on a recent chest scan.
• People with any other serious illness, abnormal test result, or condition that could make the study drugs unsafe for them or make it difficult to interpret results.
• People who have received a live vaccine within 4 weeks before joining, or who expect to need one during atezolizumab treatment or within 5 months of the last dose.
• People with a history of severe allergic reactions to certain types of laboratory-produced antibody treatments.
• People with a known allergy to components of the atezolizumab medication or to products made using a specific cell manufacturing process (Chinese hamster ovary cells).
• People with untreated or incompletely treated enlarged veins in the oesophagus or stomach that are bleeding or at high risk of bleeding — those who have had adequate treatment with no recurrent bleeding requiring transfusion or hospitalisation for more than 28 days before joining may be eligible (confirm with trial site).
• People who have received immune-stimulating medicines (such as interferon or interleukin-2) within 4 weeks or 5 drug half-lives before joining, whichever is longer.
• People who have previously received certain immune checkpoint therapies (such as anti-CTLA-4, anti-PD-1, or anti-PD-L1 treatments) — prior treatment with atezolizumab specifically is permitted.
• People who have taken systemic immune-suppressing medicines (such as corticosteroids, methotrexate, or similar drugs) within 2 weeks before joining, or who expect to need them during the study — some exceptions apply for short-term, low-dose, or specific types of corticosteroid use (confirm with trial site).
• People assigned to receive cabozantinib who have taken strong medicines that significantly interact with a liver enzyme called CYP3A4 within 14 days before joining — including rifampin or St. John's Wort (confirm full list with trial site).
• People with active tuberculosis.
• People with serious uncontrolled heart conditions, including heart failure, unstable chest pain, certain heart rhythm problems, uncontrolled high blood pressure, a recent stroke or heart attack within the past 3 months, or a blood clot within the past 3 months (some exceptions may apply — confirm with trial site).
• People with an active bacterial infection requiring treatment through the bloodstream — those on preventive antibiotics may be eligible.
• People with HIV infection, unless they have no signs of a weakened immune system and are on anti-retroviral therapy (confirm with trial site).
• People who have previously had a bone marrow or organ transplant from another person.
• People with uncontrolled fluid build-up around the lungs, heart, or abdomen that requires draining more than once a month — those with a permanent drainage catheter in place may be eligible.
• People with uncontrolled high calcium levels in the blood.
• People with uncontrolled cancer-related pain — those on a stable pain medication regimen at the time of joining may be eligible (confirm with trial site).
• People who have had another cancer within the past 5 years, with some exceptions such as certain treated skin cancers, early-stage cervical, prostate, breast, or uterine cancers (confirm with trial site).
• People who are pregnant, breastfeeding, or planning to become pregnant during treatment or within 5 months after the last dose of study medication.
• People who have had uncontrolled episodes of liver-related confusion (hepatic encephalopathy) within 6 weeks before joining — those with mild episodes (grade 2 or below) who are on appropriate supportive treatment may be eligible (confirm with trial site).

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