bTAE-HAIC Combined With Lenvatinib and Sintilimab for Infiltrative Hepatocellular Carcinoma

Inclusion Criteria:

1. Diagnosis of infiltrative HCC.

2. Infiltrative HCC was characterized as follows: nonencapsulated arterial phasehyperenhancement; tumor washout in the period of portal phase, and noncircular,ill-defined margin

3. Age between 18 and 75 years;

4. The maximum tumor size ≥10 cm, and the total tumor size ≥15 cm;

5. Infiltrative HCC, with PVTT type I or type II or limited metastases (≤5).

6. Child-Pugh class A or B;

7. Eastern Cooperative Group performance status (ECOG) score of 0-2;

8. Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3

9. Prothrombin time ≤18s or international normalized ratio < 1.7.

10. Ability to understand the protocol and to agree to and sign a written informedconsent document.

Exclusion Criteria:

1. HCC with capsule;

2. Extrahepatic metastasis >5;

3. Obstructive PVTT involving the main portal vein.

4. Serious medical comorbidities.

5. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding orhepatic encephalopathy

6. Known history of HIV

7. History of organ allograft

8. Known or suspected allergy to the investigational agents or any agent given inassociation with this trial.

9. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy

10. Evidence of bleeding diathesis.

11. Patients with clinically significant gastrointestinal bleeding within 30 days priorto study entry.