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 and dated a written consent form before any trial-related procedures begin
• People who have been clinically confirmed to have liver cancer (hepatocellular carcinoma) that cannot be surgically removed or has spread to other parts of the body
• People aged 18 to 75 years old, of any gender
• People whose general physical functioning is rated at 0 or 1 on a standard medical activity scale, meaning they are fully active or have only minor limitations in strenuous activity
• People whose doctors estimate they are likely to live more than 3 months
• People whose liver cancer has been staged as BCLC Stage B or C (a standard staging system for liver cancer)
• People whose doctors consider them suitable for a procedure called TACE, where chemotherapy is delivered directly to liver tumours through the blood vessels
• People whose liver function score (called Child-Pugh) is 7 or below, indicating reasonable liver function
• People who have at least one tumour that can be measured using standard imaging guidelines

Who may not be able to join:

• People whose liver cancer has been confirmed to contain certain specific rare cell types (fibrolamellar, sarcomatoid, or cholangiocarcinoma components)
• People who have previously had a liver transplant or have experienced a condition called hepatic encephalopathy (a liver-related brain condition)
• People whose liver cancer is classified as diffuse, meaning it is spread throughout the liver in a widespread pattern
• People who are unable to tolerate the TACE procedure, or who have already received TACE treatment
• People who have previously had any liver-directed artery-based treatment, including TACE, TAE, or TARE (various procedures that treat liver tumours through the blood vessels)
• People who have previously received any systemic anti-cancer therapy or radiotherapy for their liver cancer
• People who have a blood clot blocking the main portal vein supplying the liver without sufficient alternative blood flow, or a clot involving certain nearby major blood vessels
• People who currently have fluid build-up in the chest, abdomen, or around the heart that requires drainage
• People with any history of kidney disease or a kidney condition called nephrotic syndrome
• People who have had bleeding from swollen veins in the oesophagus or stomach (related to high blood pressure in the liver's blood supply system) in the past 6 months, or who have severe swollen veins shown on a recent camera examination of the digestive tract, or who show signs of high liver blood pressure with a high risk of bleeding as assessed by a doctor
• People who have experienced a life-threatening bleeding event in the past 3 months that required a blood transfusion, surgery, local treatment, or ongoing medication
• People who have had a serious blood clot or blockage in an artery or vein in the past 6 months, such as a heart attack, unstable chest pain, stroke, mini-stroke, blood clot in the lungs, deep vein clot, or other serious clotting event (some exceptions may apply — confirm with trial site)
• People with a significant tendency to bleed or problems with blood clotting, or who are currently receiving clot-dissolving therapy
• People who require long-term use of blood-thinning medications that affect platelet function, such as aspirin, dipyridamole, or clopidogrel
• People with high blood pressure that cannot be controlled with medication (above certain set levels), or who have a history of a hypertensive crisis or hypertension-related brain condition
• People with moderate to severe heart failure causing symptoms, poorly controlled irregular heartbeat, a condition called long QT syndrome present from birth, or an abnormal heart electrical reading above a certain threshold on a screening test
• People who have had a hole or abnormal opening in the digestive tract, a bowel blockage, or extensive bowel surgery in the past 6 months, or who have Crohn's disease, ulcerative colitis, or ongoing long-term diarrhoea
• People who have had major surgery (such as brain, chest, or abdominal surgery) within 4 weeks before starting the trial, or who have wounds, ulcers, or fractures that have not yet healed; also people who have had a minor surgical procedure (other than placement of an intravenous line) within 7 days before starting
• People with a history of or current serious lung conditions such as pulmonary fibrosis, interstitial lung disease, lung disease caused by inhaled particles, drug-related lung damage, or severely reduced lung function
• People with active tuberculosis, currently receiving anti-tuberculosis treatment, or who received such treatment within the past year
• People known to have HIV infection or active syphilis
• People with an active or poorly controlled serious infection, or who had a severe infection requiring hospitalisation within the past 4 weeks
• People with an active autoimmune disease that required systemic medical treatment within the past 2 years (some replacement therapies are allowed — confirm with trial site)
• People who have taken immune-suppressing medications within the past 4 weeks, with some exceptions for low-dose or locally applied steroids (confirm with trial site)
• People who have received a live vaccine within 4 weeks before starting the trial, or who plan to receive one during the study
• People who have used certain traditional Chinese medicines with anti-tumour or immune-modifying effects within 2 weeks before starting the trial
• People with uncontrolled or uncorrectable metabolic disorders or other serious non-cancer organ or system diseases that could affect safety or survival assessment
• People diagnosed with another cancer within the past 5 years, with some exceptions for certain fully treated skin cancers or pre-invasive cancers (confirm with trial site)
• People who have previously received certain types of immunotherapy, including anti-PD-1, anti-PD-L1/L2, anti-CTLA-4 antibody treatments, or similar therapies
• People with a known allergy to the study drugs Sintilimab or Bevacizumab, or to their ingredients, or who have had a severe allergic reaction to similar antibody-based medicines
• People who have participated in another clinical drug trial within the past 4 weeks
• People who are pregnant or currently breastfeeding
• People who have any other medical, psychiatric, or laboratory condition that the trial doctor judges would make participation unsafe or affect the reliability of the trial results

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