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

NCT05751343 | Recruiting Phase 2

• 1 other identifier: 2022-FXY-141
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  objective response rate based on RECIST 1.1

  12 months

Secondary Outcomes (4)

• objective response rate based mRECIST

  12 months

• progress-free survival

  12 months

• overall survival

  12 months

• adverse event

  12 months

Study Arms (1)

TACE-HAIC plus atezolizumab-bevacizumab

EXPERIMENTAL

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

Drug: TACE-HACI, plus atezolizumab-bevacizumab

Interventions

TACE-HACI, plus atezolizumab-bevacizumab DRUG

transartery chemoembolization and artery infusion of FOLFOX, simultaneously followed by intravenous atezolizumab plus bevacizumab

TACE-HAIC plus atezolizumab-bevacizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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);

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The TACE-HAIC which was performed using 30 mg/m2 of epirubicin mixed with 2-5 mL lipiodol, followed by pure lipiodol. Then, a catheter was placed and fixed in the tumor feeding artery for the FOLFOX-based chemotherapy infusion at the following dosage: 85 mg/m2 of oxaliplatin infusion for 2 hours; leucovorin, 400 mg/m2 infusion for 2 hours; 400 mg/m2 of 5-FU bolus; and 1200mg/m2 of continuous 5-FU infusion for 23 hours, respectively. Repeated TACE-HAIC was performed at intervals of 3-4 weeks

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 2, 2023
• Study Start: March 9, 2023
• Primary Completion: August 28, 2024
• Study Completion: December 30, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)