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:

• Adults aged 18 or older with a body weight above 30 kg.
• People with a life expectancy of at least 12 weeks.
• People who have been diagnosed with hepatocellular carcinoma (a type of liver cancer), confirmed either by tissue biopsy or by standard clinical criteria in people with liver scarring (cirrhosis).
• People who have not previously received any systemic (whole-body) treatment for this liver cancer.
• People whose liver cancer cannot be surgically removed and is not suitable for local targeted treatments, or who have already completed a local targeted treatment at least 28 days before the study's baseline scan.
• People whose liver cancer is classified at a specific stage (BCLC stage B, not suitable for local treatment, or stage C).
• People whose liver function falls within a specific acceptable range based on standard scoring (Child-Pugh class A, or class B with a score of 7 due to low albumin levels only).
• People with a good general activity level, able to carry out daily activities with minimal or no limitations (ECOG score of 0 or 1).
• People who have at least one measurable tumour site that has not previously been treated with radiation, measuring at least 10 mm (or 15 mm for lymph nodes), visible on CT or MRI scan.
• People with an active hepatitis B virus (HBV) infection, provided they are already receiving antiviral treatment that has shown signs of controlling the virus before joining the trial.
• People who test positive for certain hepatitis B markers but have undetectable virus levels in the blood — these participants would be monitored regularly throughout the trial, and antiviral treatment would be started if the virus becomes detectable.
• People with an active hepatitis C virus (HCV) infection, provided it is managed according to local medical practice.
• People whose organs (such as liver, kidneys, and bone marrow) are functioning at an adequate level, confirmed by blood tests within 14 days before joining.
• People of childbearing potential who agree to use highly effective contraception from enrolment until at least 90 days after the last dose of one study drug (durvalumab) or 180 days after the last dose of another (tremelimumab), whichever is later.
• People who agree not to donate blood for at least 90 days after the last dose of certain study drugs, or 7 days after the last dose of another study drug (lenvatinib), whichever is longest.

Who may not be able to join:

• People with a history of another cancer, unless it was a non-melanoma skin cancer, cervical cancer caught at an early stage, or another cancer that was fully treated with no signs of return for at least 5 years.
• People currently receiving other chemotherapy, cancer study drugs, or cancer-related hormonal or biological therapies (hormonal therapy for non-cancer reasons, such as hormone replacement therapy, is acceptable).
• People whose liver cancer is a specific rare type, including fibrolamellar, sarcomatoid, infiltrative, or mixed with bile duct cancer.
• People with a significant build-up of fluid in the abdomen that requires non-medication procedures to manage.
• People with uncontrolled high blood pressure (blood pressure of 150/90 mmHg or higher, or related heart complications) despite standard treatment.
• People who have previously been treated with certain types of immune-based cancer therapies, including drugs similar to durvalumab or tremelimumab.
• People with a history of primary immune system deficiency, organ transplant, or a severe immune-related reaction (grade 3 or 4) from a previous immunotherapy treatment.
• People known to be HIV positive or to have an active tuberculosis infection.
• People with a known allergy or sensitivity to any of the study drugs or their ingredients.
• People who have used immune-suppressing medications in the 28 days before starting the trial.
• People with active or previously documented autoimmune or inflammatory conditions, such as Crohn's disease, ulcerative colitis, lupus, rheumatoid arthritis, Graves' disease, sarcoidosis, or similar conditions.
• People with active or uncontrolled ongoing illness.
• People with a history of cancer spreading to the membranes surrounding the brain and spinal cord.
• People with brain metastases (cancer spread to the brain) that are causing symptoms or are not controlled, and require active treatment such as surgery, radiation, or steroids.
• People who have had a major surgical procedure within 28 days before joining the trial.
• People with a specific type of heart rhythm abnormality detected on an ECG (a QTcF interval of 470 ms or more).
• People who have received a live vaccine (such as MMR, chickenpox, yellow fever, or oral typhoid) within 30 days before joining the trial.
• People who are currently breastfeeding.
• People with any active condition that would make the trial treatment unsafe or prevent them from receiving it properly.
• People who have received radiotherapy within four weeks before the first planned dose of the study drugs — except for a single low-dose radiation treatment for pain relief given up to 14 days before joining.
• People who have had active gastrointestinal bleeding (such as from oesophageal varices or stomach ulcers) within the past 6 months. People with a history of such bleeding more than 6 months ago, or who are considered at high risk, may need to undergo an assessment and treatment of any varices before being considered (confirm with trial site).

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