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

Phase 2RecruitingNCT05751343

Sun Yat-sen University55 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatocellular Carcinoma

Interventions

TACE-HACI, plus atezolizumab-bevacizumabDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

Objective response rate

objective response rate based on RECIST 1.1

Time frame: 12 months

Secondary Outcomes

objective response rate based mRECIST

objective response rate based on modified RECIST criteria

Time frame: 12 months

progress-free survival

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.

Time frame: 12 months

overall survival

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

Time frame: 12 months

adverse event

adverse event was assessed according to the NCI-CTCAEV 5.0

Time frame: 12 months

Data from ClinicalTrials.gov

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