advanced hepatocellular carcinoma
Conditions
Interventions
nED group:No
ED group:No
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-80 years with hepatocellular carcinoma (HCC) and an estimated life expectancy exceeding 12 weeks. 2. Diagnosis of HCC confirmed either histopathologically or clinically based on the American Association for the Study of Liver Diseases (AASLD) practice guidelines for HCC. 3. Disease Stage: Barcelona Clinic Liver Cancer (BCLC) Stage C. 4. Presence of a single intrahepatic tumor nodule with a diameter = 90 g/L b. White Blood Cell (WBC) Count >= 3.0 × 10?/L c. Absolute Neutrophil Count (ANC) >= 1.5 × 10?/L d. Platelet Count (PLT) >= 50 × 10?/L e. Prolongation of Prothrombin Time (PT) = 30 g/L;b. Biochemical function meeting the following criteria: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) within 5 times the upper limit of normal (ULN), Total Bilirubin (TBIL) <= 50 µmol/L, Creatinine within 1.5 times the ULN; 10. Willingness and ability of the patient and/or their legal representative to provide written informed consent for participation in the clinical trial.
Exclusion criteria
Exclusion criteria: 1. Patients with severe pulmonary dysfunction or active tuberculosis. 2. Patients with a history of autoimmune diseases. 3. Patients with myocardial ischemia or myocardial infarction of grade II or higher, or poorly controlled arrhythmias (including QTc interval >= 450 ms for males or >= 470 ms for females). 4. Patients with severe coagulation dysfunction that is not correctable. 5. Patients with a known allergy to any component of the targeted therapy drugs used for hepatocellular carcinoma. 6. Patients with a known allergy to any component of the immunotherapy drugs used for hepatocellular carcinoma. 7. History of moderate or severe ascites, hemorrhagic esophageal varices, hepatic encephalopathy, or pleural effusion related to hepatic insufficiency within the past 3 months. 8. Patients with gastrointestinal ulcer, intestinal perforation, or intestinal obstruction. 9. Patients within 30 days of major surgery. 10. Hypertensive patients with poorly controlled blood pressure despite antihypertensive medication (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg). 11. Urinalysis showing urine protein >= ++ or confirmed 24-hour urinary protein quantification > 1.0 g. 12. Patients with active infection or unexplained fever (body temperature > 38.5°C) during the screening period or before the first dose. 13. Any other clinically significant metabolic abnormality (e.g., uncontrolled diabetes, thyroid dysfunction), physical examination finding, or laboratory abnormality that, in the investigator's judgment, suggests a condition unsuitable for the study drug (e.g., epilepsy requiring treatment), may compromise interpretation of study results, or places the patient at high risk. 14. Pregnant or lactating female patients. 15. Patients with immunosuppression. 16. Patients with active infection, or unexplained fever > 38.5°C before the first dose. 17. History of psychiatric disorder or substance abuse. 18. Patient and/or family member unwilling to participate in the clinical trial. 19. Any other condition that, in the investigator's opinion, would lead to premature termination of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Overall survival;Objective response rate; | — |
Countries
China
Contacts
Public ContactXuefeng Kan
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed