Liver Cancer
Conditions
Interventions
Intervention group:Before surgery for liver cancer, interventional combined targeted immunotherapy was performed for 2 cycles
Sponsors
The First Affiliated Hospital of Xiamen University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the informed consent form; 2. Age = 18 years old and = 80 years old, male or female; 3. Meet the clinical diagnostic criteria of the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 Edition) or be pathological Patients with histologically or cytologically confirmed hepatocellular carcinoma (HCC) and assessed as acceptable Patients undergoing surgery (ablation, liver resection, liver transplantation); 4. Clinical staging of liver cancer in China (CNLC): IB-IIA; Assessed by the investigator to have an adjacent liver large ducts (arteries, veins, bile ducts) with visceral access, no capsule, and suspicious on imaging possible high-risk factors such as foci or microvascular metastases; 5. Subjects must have at least one measurable lesion according to mRECIST criteria; 6. Tumor burden = 60%; 7. Child-Pugh score of liver function=7 points; 8. United States Eastern Cooperative Oncology Group (ECOG) score =1; 9. Expected survival time=3 months; 10. No previous anti-tumor therapy, including liver local therapy and systemic therapy; 11. Blood routine and liver and kidney function meet the following requirements (no blood transfusion, no human albumin injection, and no correction treatment with cytokine drugs such as G-CSF within 14 days before screening): Hemoglobin (HB) = 90 g/L; Absolute neutrophil count (ANC) = 1.5×109/L; White blood cell count (WBC) = 3.0×109/L and 30 g/L; Serum creatinine (Cr) = 1.5×ULN or muscle calculated according to the Cockcroft-Gault formula Anhydride clearance (CrCL) = 50 mL/min; ? Activated partial thromboplastin time (APTT) = 1.5×ULN, while the international normalized ratio (INR) or prothrombin time (PT) = 1.5×ULN; 12. For women who are not postmenopausal (non-treatment-induced amenorrhea for =12 months) or who have not undergone surgical sterilization (removal of ovaries and/or uterus): agree to remain abstinent or use a single or combined contraceptive method with an annual failure rate of 1% for the duration of treatment and for at least 6 months after the last dose. 13. Male patients must agree to use a highly effective method of contraception for the duration of the study and for 6 months after the last administration of study drug.
Exclusion criteria
Exclusion criteria: 1. Patients who have received prior surgery, local therapy, or systemic anti-tumor therapy after the diagnosis of HCC; 2. Liver cancer involving the left and right lobes of the liver or diffuse liver cancer is diagnosed; 3. Liver cancer invades the biliary tract or causes biliary obstruction; 4. Patients with regional lymph nodes or extrahepatic metastases, or malignant tumors other than liver cancer; 5. Presence of portal trunk cancer thrombus; 6. Have contraindications to angiography and selective liver catheterization, or have a strong appetite for contrast agents, anesthetics, severe allergy or intolerance to sedatives; 7. Known or suspected allergy to any study-related medications; 8. Hepatic arterial perfusion scintigraphy suggests gastrointestinal shunt, or the presence of other lateral hepatic branches blood supply to the tumor, all of which cannot be corrected by vascular interventional techniques; 9. Portal hypertension with ascites or history of gastric variceal bleeding within 6 months prior to the screening period; 10. Severe pulmonary insufficiency (FEV1/FVC<50%, or maximum ventilation MVV<50 L/min), or a prior history of interstitial lung disease; 11. Biliary system insufficiency, previous biliary intervention, or hepatopancreatic ampulla (Vater ampulla). Injure; 12. Active infection, including tuberculosis (clinical diagnosis includes clinical history, physical examination, and imaging finding, as well as tuberculosis testing according to local medical practice), hepatitis B (HBsAg positive and HBV DNA test values greater than 1000 cps/mL or 500 IU/mL), or hepatitis C (HCV antibody positive and HCV viral titer test values above the upper limit of normal); 13. HIV-positive or acquired immunodeficiency syndrome (AIDS) patients; 14. Presence of any active, known or suspected autoimmune disease; 15. History of severe cardiac arrhythmia or heart failure; 16. Pregnant and lactating women; 17. Participation in other clinical trials within 30 days prior to enrollment (except observational, non-interventional studies); 18. Other situations that the investigator considers unsuitable to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Countries
China
Contacts
Public ContactZhimin Li
The First Affiliated Hospital of Xiamen University
Outcome results
None listed