Overview
This study intends to evaluate the efficacy and safety of drug-eluting transcatheter arterial embolization-hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin (dTACE-HAIC) plus Bevacizumab and Atezolizumab for patients with intermediate-advanced huge hepatocellular carcinoma.
Description
Drug-eluting transcatheter arterial embolization (dTACE) and hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin are effective and safe for hepatocellular carcinoma. Atezolizumab + Bevacizumab was superior to sorafenib in overall survival in advanced hepatocellular carcinoma. The anti-VEGF combined programmed cell death protein-1 legend 1 (PD-L1) inhibitor were effective and tolerable in patients with advanced hepatocellular carcinoma. We aimed to describe the efficacy and safety of locoregional therapy (dTACE/HAIC) combined with Bevacizumab and Atezolizumab inhibitor in patients with huge hepatocellular carcinoma who can not receive radical therapy.
Eligibility
Inclusion Criteria:
- Clinical diagnosis of HCC.
- Age between 18 and 75 years;
- The maximum tumor size ≥10 cm;
- Intermediate-advanced huge HCC, advanced HCC with PVTT type I-III
- limited metastases (≤5).
- Child-Pugh class A or B;
- Eastern Cooperative Group performance status (ECOG) score of 0-1;
- 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:
- Diffuse HCC;
- Extrahepatic metastasis >5;
- Obstructive PVTT involving mesenteric vena cava (PVTT IV).
- Serious medical comorbidities.
- Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
- untreated or incompletely treated esophageal or gastric varices (assessed with esophagogastroduodenoscopy) with bleeding or high risk of bleeding.
- Eastern Cooperative Group performance status (ECOG) score of ≥2;
- 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.