dTACE-HAIC Combined With Bevacizumab and Atezolizumab for Huge Hepatocellular Carcinoma

Sun Yat-sen University

Status: Enrolling

Conditions: Atezolizumab; Chemotherapy; Bevacizumab; Advanced Hepatocellular Carcinoma

Treatments: Procedure: dTACE-HAIC

Study type: Interventional

Funder types: Other

Identifiers

NCT06609863

Liver Projiect 9

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Clinical diagnosis of HCC.
2. Age between 18 and 75 years;
3. The maximum tumor size ≥10 cm;
4. Intermediate-advanced huge HCC, advanced HCC with PVTT type I-III
5. limited metastases (≤5).
6. Child-Pugh class A or B;
7. Eastern Cooperative Group performance status (ECOG) score of 0-1;
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 ≤ 1.5 or 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 informed consent document.

Exclusion criteria

1. Diffuse HCC;
2. Extrahepatic metastasis >5;
3. Obstructive PVTT involving mesenteric vena cava (PVTT IV).
4. Serious medical comorbidities.
5. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
6. untreated or incompletely treated esophageal or gastric varices (assessed with esophagogastroduodenoscopy) with bleeding or high risk of bleeding.
7. Eastern Cooperative Group performance status (ECOG) score of ≥2;
8. Known or suspected allergy to the investigational agents or any agent given in association 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 prior to study entry.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

dTACE-HAIC plus Bevacizumab and Atezolizumab

Experimental group

Description:

dTACE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then drug-eluting microspheres was used (100-300um, 300-500um). Hepatic arterial infusion of oxaliplatin, fluorouracil, and leucovorin every 4 weeks. Lenvatinib 12 mg (or 8 mg) once daily (QD) oral dosing. Toripalimab, 200 mg intravenously every 2 weeks.

Treatment:

Procedure: dTACE-HAIC