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 who have signed a written consent form before any trial-related procedures begin.
• Adults aged 18 to 70 years (male or female).
• People whose general physical functioning is rated at a level where they are fully active, restricted in physically strenuous activity, or capable of self-care but unable to work (this is measured on a standard scale called ECOG PS, scored 0–2).
• People diagnosed with hepatocellular carcinoma (a type of liver cancer) according to specific Chinese clinical guidelines (2019 Edition).
• People whose liver cancer is at a stage where the cancer has spread into nearby blood vessels but has not spread to other parts of the body outside the liver (called CNLC stage IIIa).
• People whose liver function is rated as Class A or B on a standard scoring system called Child-Pugh.
• People whose portal vein (the main blood vessel supplying the liver) has a specific level of cancer involvement, classified as type 1 or 2 under one classification system, or type I or II under another (confirm with trial site).
• People who have not previously received any systemic (whole-body) anti-cancer treatment for their liver cancer, and whose cancer may be suitable for complete surgical removal (R0 resection).
• People whose expected survival is longer than 3 months.
• People who have at least one measurable tumour lesion, as assessed using standard measurement criteria.
• People whose blood, liver, kidney, and clotting test results meet specific minimum thresholds showing adequate organ function (confirm exact values with trial site).
• People with hepatitis B or C who are receiving continuous antiviral treatment throughout the study.
• Female participants of childbearing age who have a negative pregnancy test within 3 days before starting the study drug.
• People who agree to use a highly effective method of contraception (with a failure rate below 1%) from the start of treatment until at least 120 days after the last dose of the study drug (or 180 days after the last chemotherapy dose), if there is any risk of pregnancy — this applies to participants of any gender.

Who may not be able to join:

• People whose liver cancer has been confirmed to include certain rare subtypes, such as fibrolamellar, sarcomatoid hepatocellular carcinoma, or cholangiocarcinoma (bile duct cancer).
• People with a history of hepatic encephalopathy (a brain condition caused by liver failure) or who have had a liver transplant.
• People who currently need medical drainage of fluid build-up in the chest, abdomen, or around the heart.
• People with active hepatitis B or C infection where virus levels in the blood are above specified limits, or who test positive for both hepatitis B surface antigen and hepatitis C antibodies.
• People whose cancer has spread to the brain or central nervous system.
• People who have had bleeding from oesophageal or stomach varices (swollen veins caused by liver-related high blood pressure) in the past 6 months, have been found to have severe varices on a recent scope examination, or have signs of high blood pressure in the portal vein with a high risk of bleeding.
• People who have experienced any life-threatening bleeding event in the past 3 months, including events requiring blood transfusion, surgery, or ongoing medication.
• People who have had a serious blood clot or blockage in a vein or artery in the past 6 months — such as a heart attack, unstable chest pain, stroke, mini-stroke, pulmonary embolism, or deep vein thrombosis — unless the clot is stable and well-managed with standard anticoagulation therapy.
• People who have taken high-dose aspirin (more than 325 mg per day) or certain other blood-thinning or platelet-affecting medications for 10 or more consecutive days within the 2 weeks before starting the trial.
• People with blood pressure that remains too high (above 150/90 mmHg) despite optimal medical treatment, or who have a history of hypertensive crisis or hypertensive encephalopathy.
• People with symptomatic heart failure, poorly controlled irregular heart rhythm, a history of a specific inherited heart rhythm condition (long QT syndrome), or an abnormal heart rhythm measurement above a certain threshold on an ECG.
• People with a serious tendency to bleed, a clotting disorder, or who are currently receiving clot-dissolving (thrombolytic) therapy.
• People with a history of bowel perforation, fistula, bowel obstruction, large bowel resection, Crohn's disease, ulcerative colitis, or long-term chronic diarrhoea within the past 6 months.
• People who received radiotherapy within 3 weeks before starting the trial, or who received it more than 3 weeks ago but still have ongoing side effects, require steroids for those effects, or have developed radiation-related damage to the lungs, liver, or bowel.
• People with a history of pulmonary fibrosis, interstitial lung disease, dust-related lung disease, drug-related lung inflammation, or severely reduced lung function.
• People who are HIV-positive or have a known active syphilis infection.
• People with an active or poorly controlled severe infection, or who were hospitalised for a serious infection within the 4 weeks before starting the trial.
• People with an active or poorly controlled autoimmune disease that required systemic treatment within the past 2 years, or with a known history of primary immune deficiency.
• People who have used immunosuppressive medications within the 4 weeks before starting the trial (with some exceptions, such as low-dose inhaled or topical steroids).
• People who have received a live attenuated vaccine within 4 weeks before starting the trial, or who plan to receive one during the study.
• People who received any local treatment directly targeting their liver cancer within the 4 weeks before starting the trial.
• People who received certain traditional Chinese medicines with anti-tumour effects, or immune-modifying drugs such as thymosin, interferon, or interleukins, within 2 weeks before starting the trial.
• People with uncontrolled or uncorrectable metabolic conditions or other serious non-cancer-related organ diseases that could affect safety or make it difficult to assess results.
• People diagnosed with another type of cancer within the 5 years before starting the trial, with some exceptions such as fully removed skin cancers or in-situ carcinomas.
• People who have previously received any immunotherapy drugs targeting PD-1, PD-L1/L2, or CTLA-4 pathways.
• People with a known allergy to any ingredient in sintilimab, lenvatinib, or the chemotherapy drugs used in the trial, or who have had a severe allergic reaction to similar types of medications.
• People who have participated in another clinical trial within the 4 weeks before starting this trial.
• People who are pregnant or breastfeeding.
• People with other significant medical conditions, mental health conditions, or abnormal test results that the treating doctor considers would make participation unsafe or affect the reliability of the trial results.

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