Atezolizumab and Bevacizumab Plus TACE-HAIC for Unresectable Advanced HCC: a Phase 2 Clinical Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TACE-HACI, plus atezolizumab-bevacizumab.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Atezolizumab Plus Bevacizumab Plus Transarterial Chemoembolization and Hepatic Artery Infusion Chemotherapy for Unresectable Advanced Hepatocellular Carcinoma: a Single-arm Phase 2 Clinical Trial
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.
Interventions
- Drug TACE-HACI, plus atezolizumab-bevacizumab
transartery chemoembolization and artery infusion of FOLFOX, simultaneously followed by intravenous atezolizumab plus bevacizumab
Primary outcome measures
- Objective response rate [Time frame: 12 months]
Secondary outcome measures (4)
- objective response rate based mRECIST [Time frame: 12 months]
- progress-free survival [Time frame: 12 months]
- overall survival [Time frame: 12 months]
- adverse event [Time frame: 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-sen University Cancer Center — Guangzhou
Identifiers
NCT: NCT05751343 · 2022-FXY-141