Atezolizumab and Bevacizumab Plus TACE-HAIC for Unresectable Advanced HCC: a Phase 2 Clinical Trial

Sun Yat-sen University

Status and phase: Enrolling; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Drug: TACE-HACI, plus atezolizumab-bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT05751343

2022-FXY-141

Details and patient eligibility

About

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.

Enrollment: 55 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

TACE-HAIC plus atezolizumab-bevacizumab

Experimental group

Description:

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

Treatment:

Drug: TACE-HACI, plus atezolizumab-bevacizumab