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NCT Number: NCT05751343

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

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location status: Recruiting

Location contact

Jiliang Qiu

CONTACT

[email protected]

+862087342651

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TACE-HACI, plus atezolizumab-bevacizumab

Drug

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

Primary outcomes

  1. Objective response rate

    Time frame: 12 months

    objective response rate based on RECIST 1.1

Secondary outcomes

  1. objective response rate based mRECIST

    Time frame: 12 months

    objective response rate based on modified RECIST criteria

  2. progress-free survival

    Time frame: 12 months

    Progress-free survival (PFS) was defined from the date of treatment to the first image-confirmed progress based on RECIST 1.1, last follow-up or died.

  3. overall survival

    Time frame: 12 months

    Overall survival was defined from the date of treatment to the date of died or last follow-up

  4. adverse event

    Time frame: 12 months

    adverse event was assessed according to the NCI-CTCAEV 5.0

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Mar 2, 2023
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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