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 aged 18 or older who are willing to sign a consent form and follow the study requirements.
• People with a confirmed diagnosis of liver cancer (hepatocellular carcinoma, or HCC), either through a tissue sample or by standard clinical criteria.
• People whose liver cancer is at an advanced stage (BCLC Stage C, or Stage B that has spread through both sides of the liver in a way that only systemic medication is appropriate, and surgery, transplant, or local treatments are not suitable).
• For Stage 1 of the trial: People whose cancer has stopped responding to at least one prior standard treatment, who have no other standard treatment options available, or who were unable to tolerate standard treatment.
• For Stage 2 of the trial: People whose cancer has stopped responding to at least one prior standard treatment, or who were unable to tolerate it.
• For Stage 3 of the trial: People whose cancer progressed, or who were unable to tolerate (after at least 28 days of treatment), exactly one prior course of immunotherapy involving a specific type of drug (anti-PD-1/PD-L1 antibody), given alone or in combination — prior local treatments to the liver do not count toward this, but disease progression after those treatments must have been documented, and at least 4 weeks must have passed since the last such treatment.
• For Stages 2 and 3: People whom the treating doctor considers suitable for treatment with Sorafenib based on the medication's guidelines and clinical judgment.
• People who have a performance status score of 0 or 1 (meaning fully active or able to carry out light activity) within 7 days before the first dose.
• People who have at least one measurable area of cancer that has not been treated with local procedures such as chemoembolization, radiofrequency ablation, or similar methods (a new area of growth near a previously treated site may be acceptable if it can be clearly measured).
• People whose life expectancy the treating doctor judges to be more than 12 weeks.
• People who have recovered from side effects of prior cancer treatments to a mild or stable level before joining.
• For Stages 2 and 3: People who are willing to provide an existing stored tissue sample, or agree to have a biopsy taken, for testing — though not being able to provide a sample will not automatically prevent participation (confirm with trial site).
• People whose liver, kidney, and blood test results meet specific minimum levels of organ function set by the trial (confirm with trial site for exact values).
• People with hepatitis B (HBV) infection, provided the virus is either resolved or, if ongoing, the viral level is below a specific threshold and is being managed with antiviral medication started at least 2 weeks before the first dose.
• People with hepatitis C (HCV) infection, provided the infection is resolved or stable and is not currently requiring direct antiviral treatment.
• Women who could become pregnant must have a negative pregnancy test within 3 days before the first dose and must use highly effective contraception from consent through 6 months after the last dose; male participants must also use adequate contraception during the study and for 3 months after the last dose, or be surgically sterile.

Who may not be able to join:

• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the study period.
• For Stages 2 and 3: People whose liver cancer is of a specific less common type (fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma).
• People whose main portal vein or major vein returning blood to the heart is completely blocked by the liver cancer.
• People who have had major surgery within 4 weeks before the first dose.
• People with a known allergy or sensitivity to the study drug (WGI-0301), similar drugs, or liposomal (fat-based) drug formulations.
• For Stages 2 and 3: People with a known allergy or sensitivity to Sorafenib or similar drugs.
• For Stage 3 only: People who have previously received Sorafenib or drugs that target a specific molecular pathway called AKT-PI3K.
• People who are currently in another clinical trial receiving an experimental treatment, or who received such treatment within the 4 weeks before the first dose (observational studies are generally excluded from this rule — confirm with trial site).
• People who have had local liver treatments such as chemoembolization, radiotherapy, or ablation within 4 weeks before the first dose (palliative bone pain radiotherapy completed at least 2 weeks prior may be acceptable — confirm with trial site).
• People who have received certain targeted cancer drugs or traditional Chinese herbal medicines with anti-tumour indications within 2 weeks before the first dose, or chemotherapy, biological therapies, or other anti-tumour treatments within 4 weeks before the first dose.
• For Stages 2 and 3: People who have taken strong CYP3A4 inducer medications (a category of drugs that can affect how other medicines are processed by the body) within 12 days before the first dose (confirm with trial site for the specific drug list).
• People with clinically significant blood sugar problems, such as type 1 or type 2 diabetes requiring medication, or a long-term blood sugar marker (HbA1c) of 8.0% or above.
• People with significant heart or blood pressure problems, including uncontrolled high blood pressure, low blood pressure, severe heart failure, a heart attack or stroke in the past 6 months, certain heart rhythm problems, or significantly reduced heart pumping function.
• For Stages 2 and 3: People with significant digestive tract problems, such as difficulty swallowing, conditions affecting nutrient absorption, bowel obstruction, a hole (perforation) or abnormal channel (fistula) in the gut within the past 6 months, or significant stomach or gut bleeding within the past 6 months (the presence of enlarged veins in the oesophagus or stomach without a recent bleeding episode may be acceptable — confirm with trial site).
• People with significant bleeding risks, including inherited or acquired bleeding disorders, recent coughing or vomiting of blood, use of clot-dissolving medications within 10 days before the first dose, or use of blood-thinning medications where blood clotting levels are outside the expected treatment range.
• People who have previously had a solid organ transplant (such as a kidney, heart, or lung transplant).
• People with known HIV infection or AIDS-related illness, or people who have been taking immune-suppressing medications (other than low-dose steroids) within 7 days before the first dose.
• People with a known active or uncontrolled infection currently requiring intravenous antibiotics, antiviral, or antifungal treatment.
• People with uncontrolled fluid build-up in the abdomen or around the lungs that requires repeated draining.
• People with a history of another cancer, unless it was a non-melanoma skin cancer, early-stage cervical cancer, or another cancer that was fully treated with no signs of return for at least 3 years.
• People with known cancer that has spread to the brain or central nervous system and is causing symptoms or has not been treated (asymptomatic cases not needing treatment may be acceptable — confirm with trial site).
• People with a current history of drug abuse or addiction.
• People whom the treating doctor considers unable to safely participate in the trial for any other reason.

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