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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: TACE-HACI, plus atezolizumab-bevacizumab


Participation Criteria
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Eligibility Criteria
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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 >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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 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 2400 mg/m2 of continuous 5-FU infusion for 46 hours or 1200mg/m2 of continuous 5-FU infusion for 23 hours, respectively. Repeated TACE-HAIC was performed at intervals of 3-4 weeks
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TACE-HAIC plus atezolizumab-bevacizumab<br>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<br>* transartery chemoembolization and artery infusion of FOLFOX, simultaneously followed by intravenous atezolizumab plus bevacizumab<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate | objective response rate based on mRECIST | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progress-free survival | Progress-free survival (PFS) was defined from the date of treatment to the first image-confirmed progress or died. | 12 months |