Hepatocellular Carcinoma
Conditions
Interventions
Group A:observational study
Sponsors
The Fifth Affiliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >18 years, no gender restrictions; 2. Confirmed as primary hepatocellular carcinoma (HCC) patients based on histopathological examination results or diagnostic criteria from the European Association for the Study of the Liver (EASL) / American Association for the Study of Liver Diseases (AASLD); 3. Eastern Cooperative Oncology Group (ECOG) performance status: 0–2 points; 4. According to RECIST 1.1 or modified RECIST (mRECIST) criteria, patients must have at least one measurable lesion; 5. Tumors before local and systemic treatment must meet the Super University of California, San Francisco (UCSF) criteria, where UCSF criteria include: (1) Single tumor diameter not exceeding 6.5 cm or a total of up to 3 tumors, with a maximum diameter of not more than 4.5 cm and a total tumor diameter not exceeding 8 cm; (2) Absence of vascular invasion and lymph node invasion; 6. Have received combined local treatment with tyrosine kinase inhibitors (TKIs) and programmed cell death protein 1 (PD-1) therapy for 180 days or more, and recent tumor response assessment within the last 180 days according to mRECIST criteria is partial response (PR) or complete response (CR); 7. The "Metroticket 2.0 model" (http://www.hcc-olt-metroticket.org/) predicts a 5-year survival rate of no less than 50%; 8. After appropriate supportive treatment, major organ functions meet all of the following criteria (heart, lungs, bone marrow, and kidney functions are good): (1) Left ventricular ejection fraction (LVEF) >45%; (2) Oxygenation index (PaO2/FiO2) >200 mmHg; (3) Hemoglobin =90 g/L, platelet count =75×109/L, white blood cell count =3.0×109/L, absolute neutrophil count =1.5×109/L, lymphocyte count =0.5×109/L; (4) Activated partial thromboplastin time (APTT) and international normalized ratio (INR) =1.5×ULN (patients on stable doses of anticoagulants such as low molecular weight heparin or warfarin within the expected therapeutic range for anticoagulation may be eligible); (5) Serum creatinine =1.5×ULN, glomerular filtration rate =30 mL/min/1.73 m2; 9. No history of upper gastrointestinal bleeding, hemoptysis (each time =1/2 tablespoon) within the last 9 months; 10. Complete preoperative laboratory tests and imaging data such as liver-enhanced CT and/or MRI; 11. For HBsAg (+) and/or anti-HCV (+) patients, antiviral therapy is conducted according to standard protocols based on HBV DNA or HCV RNA test results; 12. The researchers voluntarily participate in this study, exhibit good compliance, cooperate with follow-up, understand, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Fibrolamellar hepatocellular carcinoma, cholangiocarcinoma, mixed-type hepatocellular carcinoma; 2. Planned or previously undergone solid organ or allogeneic stem cell transplantation; 3. Extrahepatic distant metastasis; 4. History of receiving targeted or immune checkpoint inhibitors other than TKIs or PD-1 therapy; 5. Presence of other malignant tumors in the past 5 years or concurrently; 6. History of hepatic encephalopathy; 7. Hypertensive patients whose blood pressure cannot be well controlled after antihypertensive treatment (systolic blood pressure =150 mmHg or diastolic blood pressure =100 mmHg); 8. Presence of hypertensive crisis or history of hypertensive encephalopathy; 9. Inherited bleeding tendency or significant coagulation disorders (increased risk of bleeding without anticoagulant treatment); 10. Occurrence of major vascular diseases within 6 months (such as aortic aneurysm requiring surgical repair or recent arterial thrombosis); 11. Occurrence of major cardiovascular diseases within the 3 months preceding the start of the study (such as NYHA class II or more severe heart disease, myocardial infarction, or cerebrovascular accident), unstable arrhythmias, or unstable angina; 12. Pulmonary arterial hypertension; 13. Presence of any active autoimmune disease or a history of autoimmune disease or patients requiring long-term immunosuppressive therapy; 14. Untreated or incompletely treated esophageal and/or gastric variceal bleeding or patients at high risk of bleeding. Patients must undergo esophagogastroduodenoscopy (EGD) to assess and treat all varices (regardless of size) according to local diagnostic and treatment standards before enrollment; 15. Severe infections, such as liver abscess; 16. Severe, non-healing wounds, active ulcers, or untreated fractures; 17. Human immunodeficiency virus-positive patients; 18. Abuse of antipsychotic drugs or a history of drug abuse; 19. Male or female patients with reproductive potential unwilling to adopt effective contraception measures within 180 days from screening to liver transplantation surgery; 20. Researchers believe that patients may not necessarily complete this study or may not be able to comply with the requirements of this study (due to management reasons or other factors)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| One-year progression-free survival rate;Incidence of acute allograft rejection within 1 year post-surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;One-year tumor recurrence rate;Adverse events rate; | — |
Countries
China
Contacts
Public ContactJian Li
The Fifth Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed