Safety and Efficacy of Lenvatinib and Anti-PD1 Antibody Combined With Radiotherapy Neoadjuvant Treatment for Resectable Hepatocellular Carcinoma With PVTT

Inclusion Criteria:

1. Aged 18-70, with no gender limitation;
2. HCC patients who strictly met the clinical diagnostic criteria of The Code for TheDiagnosis and Treatment of Primary Liver Cancer (2019 edition) or were confirmed byhistopathological or cytological examination;
3. BCLC stage C, no distant metastasis;
4. Patients with PVTT of type VP1-2-3-4 according to Japanese VP Classification;
5. The primary tumor can be resected (the remaining liver has complete vascular structureand sufficient liver volume, in line with the decision-making system of safe liverresection)
6. ECOG score 0-1;
7. Child-Pugh score ≤7;
8. If the patient is HBV antigen positive, HBV DNA < 500 IU/ mL, conventional antiviraltreatment;
9. The major organs meeting the following criteria:
10. Adequate bone marrow function, defined as: Absolute neutrophil count (ANC ≥ orequal to 1.5 X 10 ^ 9 per liter (/ L)) Hemoglobin (Hb ≥ 8.5 g/dL) Platelet count ≥ 75×10 ^ 9 / L.
11. Adequate liver function, defined as: Albumin > 2.8 g/dL Bilirubin is 3.0 mg/dL orless Aspartate aminotransferase (AST), alkaline phosphatase (ALP) and alanineaminotransferase (ALT) are less than or equal to 5 ULN.
12. Adequate coagulation function, defined as an international standardized ratio ( (INR) of 2.3 or less.
13. Adequate renal function was defined as creatinine clearance greater than 40mL/min (mL/min), calculated according to the Cockcroft and Gault formulas.
14. Adequate pancreatic function, defined as amylase and lipase. = 1.5 x ULN.
15. Adequate control of blood pressure (BP) with up to 3 antihypertensive drugs, definedas BP-lt at screening time; = 150/90 mmHg (mmHg), and there was no change inantihypertensive therapy 1 week prior to cycle 1 / day 1.
16. Patients are expected to survive longer than 3 months.
17. No pregnancy or pregnancy plan.
18. Subjects voluntarily joined the study and signed informed consent with good complianceand follow-up.

Exclusion Criteria:

1. Extrahepatic metastasis of primary hepatocellular carcinoma;
2. Diffuse liver cancer;
3. Patients who had previously received targeted drugs or immune checkpoint inhibitors;
4. allergic to Lenvatinib or PD-1 inhibitor ingredients;
5. Patients with grade II or higher myocardial ischemia or myocardial infarction andpoorly controlled arrhythmias (including QTc interval ≥470 ms); Patients with gradeIII ~ IV cardiac insufficiency according to NYHA standard, or left ventricularejection fraction (LVEF) < 50% as indicated by color doppler echocardiography;
6. abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN+4 seconds orAPTT &gt; 1.5ULN), with bleeding tendency or receiving thrombolytic or anticoagulanttherapy;
7. pregnant or breast-feeding women; Fertile patients unwilling or unable to takeeffective contraceptive measures;
8. have a history of mental illness or abuse of psychotropic drugs;
9. patients with co-HIV infection;
10. a history of liver resection, liver transplantation, interventional therapy, and othermalignant tumors;
11. patients with active infection;
12. contraindications to radiotherapy;
13. Patients with poor compliance such as floating population;
14. participants in clinical trials of other experimental drugs or devices within 4 weeks;
15. those considered unsuitable for inclusion by the researcher.