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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05751343
• Other study ID #: 2022-FXY-141
• Status: Recruiting
• Phase: Phase 2
• Start date: March 9, 2023
• Est. completion date: February 28, 2025

Study information

• Verified date: March 2023
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Transartial chemobolization plus hepatic artery infusion chemotherapy showed performance for unresectable hepatocellular carcinoma (HCC). Whether the additional of atezolizumab plus bevacizumab 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 hepatocellular carcinoma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• (a) patients were diagnozied with unresectable 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 >3?109/L, absolute neutrophil count >1.5?109/L, platelet count >10?109/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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• TACE-HACI, plus atezolizumab-bevacizumab
transartery chemoembolization and artery infusion of FOLFOX, simultaneously followed by intravenous atezolizumab plus bevacizumab

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate	objective response rate based on mRECIST	12 months
Secondary	progress-free survival	Progress-free survival (PFS) was defined from the date of treatment to the first image-confirmed progress or died.	12 months