A Study of Atezolizumab in Combination With Bevacizumab in Spanish Patients With Unresectable or Unsuitable for Locoregional Treatments Hepatocellular Carcinoma Not Previously Treated With Systemic Therapy

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-04

Study Completion Date

2024-04-26

Brief Summary

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This is a Phase IIIb, one arm, multicenter, open-label study primarily designed to evaluate the safety of atezolizumab + bevacizumab in participants with unresectable or unsuitable for locoregional treatments for metastatic HCC not previously treated with systemic therapy. As part of its secondary objectives, this study is also designed to evaluate the efficacy of atezolizumab and bevacizumab in these participants.

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Detailed Description

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Conditions

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Carcinoma, Hepatocellular

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A (atezolizumab plus bevacizumab)

Participants will receive Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Group Type EXPERIMENTAL

Atezolizumab

Intervention Type DRUG

Atezolizumab will be administered intravenously at a dose of 1200 mg on Day 1 of each 21-day cycle.

Bevacizumab

Intervention Type DRUG

Bevacizumab will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle.

Interventions

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Atezolizumab

Atezolizumab will be administered intravenously at a dose of 1200 mg on Day 1 of each 21-day cycle.

Intervention Type DRUG

Bevacizumab

Bevacizumab will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle.

Intervention Type DRUG

Other Intervention Names

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Tecentriq Avastin

Eligibility Criteria

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Inclusion Criteria

* Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology or radiologically, following the AASLD criteria
* Disease that is not amenable to curative surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies
* No prior systemic therapy (including systemic investigational agents) for HCC
* At least one measurable (per RECIST 1.1) untreated lesion detected by CT scan
* Patients who received prior local therapy such as radiofrequency ablation, percutaneous ethanol or acetic acid injection, cryoablation, high-intensity focused ultrasound, transarterial chemoembolization, transarterial embolization (excluding transarterial radioembolization.) are eligible provided the target lesion(s) have not been previously treated with local therapy or the target lesion(s) within the field of local therapy have subsequently progressed in accordance with RECIST version 1.1

Exclusion Criteria

* Active or history of autoimmune disease or immune deficiency
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
* Co-infection of HBV and HCV

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No