Hepatocellular Carcinoma
Conditions
Interventions
Group A:FOLFOX-HAIC + lenvatinib + pembrolizumab" triple neoadjuvant therapy followed by surgery for resectable hepatocellular carcinoma
Group B:Only surgical treatment
Sponsors
The Fifth Affiliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.The age of patients ranged from 18 to 75 years old, with no gender restrictions. 2.Patients were confirmed as primary hepatocellular carcinoma based on histopathological examination or the diagnostic criteria of the European Association for the Study of the Liver (EASL)/American Association for the Study of Liver Diseases (AASLD). 3.The Eastern Cooperative Oncology Group (ECOG) score was between 0 and 2. 4.Liver function was classified as Child-Pugh class A or B (score 400 ng/mL. 7.The expected residual liver volume was >30%, and for patients with liver fibrosis or other chronic liver diseases, it was >40%. 8.The indocyanine green retention rate at 15 minutes (ICG-R15) was less than 15%. 9.According to the 2022 Chinese Guidelines for the Diagnosis and Treatment of Primary Liver Cancer, the liver cancer was assessed by a surgical oncology expert group and determined to be resectable in one stage. 10.The main organ functions met all of the following criteria (bone marrow, liver, and kidney function were normal): (1) Hemoglobin =90 g/L, platelet count =75×10^9/L, white blood cell count =3.0×10^9/L, neutrophil count =1.5×10^9/L; (2) Total bilirubin =2 mg/dL, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =5×ULN (upper limit of normal); (3) Coagulation function was normal, without active bleeding or thrombotic disease; activated partial thromboplastin time (APTT) and international normalized ratio (INR) =1.5×ULN (patients receiving stable dose anticoagulant therapy such as low molecular weight heparin or warfarin within the expected therapeutic range can be screened); (4) Serum creatinine =1.5×ULN, glomerular filtration rate =30 mL/min/1.73 m2. 11.Patients had not received any relevant anti-hepatocellular carcinoma treatment such as targeted therapy, immunotherapy, radiotherapy, chemotherapy, etc. before enrollment. 12/The expected survival time was =6 months. 13.For patients who were positive for HBsAg and/or anti-HCV, antiviral treatment was administered according to standard guidelines based on HBV DNA or HCV RNA test results. 14.Women of childbearing age had a negative serum or urine pregnancy test within 7 days before enrollment and used contraception during the study period (such as an intrauterine device, contraceptive pills, or condoms). 15.The researchers voluntarily participated in this study, had good compliance, cooperated with follow-up, and signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1.Poorly controlled clinical cardiovascular diseases or symptoms (such as severely abnormal electrocardiogram or myocardial enzyme tests; NYHA heart failure classification greater than grade 2; unstable angina pectoris; myocardial infarction within the past year; atrial or ventricular arrhythmias requiring treatment or intervention); 2.Patients with hypertension who cannot be well controlled after antihypertensive drug treatment (systolic blood pressure =140mmHg or diastolic blood pressure =90mmHg); history of hypertensive crisis or hypertensive encephalopathy; 3.Other malignant tumors within the past 5 years or during the same period; 4.Known or suspected allergy to the investigational product or any product related to this trial; 5.History of esophageal and gastric variceal rupture, hepatic encephalopathy, refractory ascites, and abdominal infection; severe bleeding tendency, unhealed wounds, ulcers, or fractures; 6.Coexisting hereditary or acquired bleeding and thrombotic tendencies, such as hemophilia, polycythemia vera, etc.; 7.Diseases that increase the risk of perioperative infection, such as unhealed wounds, ulcers, or fractures; 8.Any active autoimmune disease or history of autoimmune disease or patients requiring long-term use of immunosuppressive agents; 9.Pregnant or lactating patients; 10.Unable to swallow tablets completely; 11.Human immunodeficiency virus-positive patients; 12.Abuse of antipsychotic drugs or history of drug abuse. 13.The investigators believed that the subjects may not be able to complete this study or may not be able to comply with the requirements of this study (due to management reasons or other reasons).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year overall survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Recurrence-free survival;3-year recurrence-free survival;Surgical resection rate ;R0 resection rate;Pathological complete response;Major pathological response;Objective response rate;Progression-free survival rate;Disease control rate;Progression-free survival;Time to Progression;Adverse events rate; | — |
Countries
China
Contacts
Public ContactJian Li
The Fifth Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed