Atezolizumab Plus Bevacizumab Plus Transarterial Chemoembolization and Hepatic Artery Infusion Chemotherapy for Unresectable Advanced Hepatocellular Carcinoma: a Single-arm Phase 2 Clinical Trial

Sun Yat-sen University1 site in 1 country55 target enrollmentMarch 9, 2023

ConditionsHepatocellular Carcinoma

InterventionsTACE-HACI, plus atezolizumab-bevacizumab

Overview

Phase: Phase 2
Intervention: TACE-HACI, plus atezolizumab-bevacizumab
Conditions: Hepatocellular Carcinoma
Sponsor: Sun Yat-sen University
Enrollment: 55
Locations: 1
Primary Endpoint: Objective response rate
Status: Recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Atezolizumab and bevacizumab was approve for advanced unresectable hepatocellular carcinoma (aHCC). Whether the additional of transartial chemobolization and hepatic artery infusion chemotherapy will improve the response rate for those patients is still unknown. This phase 2 clinical trial aims to investigate the objective response rate for unresectable advanced hepatocellular carcinoma.

Registry

clinicaltrials.gov

Start Date

March 9, 2023

End Date

December 30, 2025

Last Updated

5 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Yunfei Yuan

Professor

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

•(a) patients were diagnozied with unresectable advanced-stage HCC,
•(b) Child-Pugh A or B liver function;
•(d) Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
•(e) adequate hematologic blood counts (white blood cell count \>3ⅹ109/L, absolute neutrophil count \>1.5ⅹ109/L, platelet count \>10ⅹ109/L, hemoglobin concentration \>85 g/L);

Exclusion Criteria

•(a) severe underlying cardiac, pulmonary, or renal diseases;
•(b) history of a second primary malignant tumor;
•(c) contraindication to either atezolizumab and bevacizumab.

Arms & Interventions

TACE-HAIC plus atezolizumab-bevacizumab

transartery chemoembolization and hepatic artery infusion of FOLFOX, simultaneously followed by intravenous of 1200mg atezolizumab plus bevacizumab (15mg/kg)

Intervention: TACE-HACI, plus atezolizumab-bevacizumab