bTAE-HAIC Combined With Lenvatinib and Sintilimab for Infiltrative Hepatocellular Carcinoma
Liver Diseases, Hepatocellular Carcinoma, Immunotherapy
About this trial
This is an interventional treatment trial for Liver Diseases
Eligibility Criteria
Inclusion Criteria: Diagnosis of infiltrative HCC. Infiltrative HCC was characterized as follows: nonencapsulated arterial phase hyperenhancement; tumor washout in the period of portal phase, and noncircular, ill-defined margin Age between 18 and 75 years; The maximum tumor size ≥10 cm, and the total tumor size ≥15 cm; Infiltrative HCC, with PVTT type I or type II or limited metastases (≤5). Child-Pugh class A or B; Eastern Cooperative Group performance status (ECOG) score of 0-2; 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 ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3 Prothrombin time ≤18s or international normalized ratio < 1.7. Ability to understand the protocol and to agree to and sign a written informed consent document. Exclusion Criteria: HCC with capsule; Extrahepatic metastasis >5; Obstructive PVTT involving the main portal vein. Serious medical comorbidities. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy Known history of HIV History of organ allograft Known or suspected allergy to the investigational agents or any agent given in association with this trial. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy Evidence of bleeding diathesis. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
Sites / Locations
- Sun Yat-sen University Cancer Center
Arms of the Study
Arm 1
Experimental
bTAE-HAIC combined with Lenvatinib and Sintilimab
bTAE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then blank microspheres were used according to the tumor blood supply vessels (40-120um, 100-300um, 300-500um, 500-700um). Hepatic arterial infusion of oxaliplatin, fluorouracil, and leucovorin every 4 weeks. Lenvatinib 12 mg (or 8 mg) once daily (QD) oral dosing. Sintilimab, 200 mg intravenously every 3 weeks.