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Monoclonal Antibodies

Atezolizumab + Bevacizumab + TACE for Liver Cancer

Phase 2

Recruiting

Led By Stacy Stein, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial will study combining local treatment (TACE) with drugs (atezolizumab, bevacizumab) to improve treatment of intermediate hepatocellular carcinoma (HCC) and increase the response to immune therapy.

Who is the study for?

This trial is for adults with intermediate-stage liver cancer (BCLC B HCC) who can handle the study procedures and have a life expectancy of at least 6 months. They should not have severe cirrhosis, must be eligible for TACE therapy, and need to have good liver, bone marrow, and kidney function. People with certain hepatitis conditions can join if they meet specific criteria.Check my eligibility

What is being tested?

The trial tests Atezolizumab and Bevacizumab in combination with Transarterial Chemoembolization (TACE). It aims to see if this combo helps patients by increasing the immune system's response to cancer after local tumor treatment.See study design

What are the potential side effects?

Atezolizumab may cause immune-related reactions or infections; Bevacizumab might lead to high blood pressure or bleeding issues; TACE could result in abdominal pain or fever. Each patient's side effects will vary.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Grade 3 or higher Treatment Related Adverse Events

Secondary outcome measures

Response rate in Hepatocellular Carcinoma

Response rate in Solid Tumors

Time to TACE progression (TTTP)

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Atezolizumab and Bevacizumab in combination with TACEExperimental Treatment3 Interventions

THIS IS A SINGLE ARM PILOT/FEASABILITY STUDY. THE STUDY CONSISTS OF A SCREENING PERIOD (DAY -28 TO DAY -1), A TREATMENT PERIOD, AND A TREATMENT DISCONTINUATION VISIT. The atezolizumab and bevacizumab combination will be given every 21 days, atezolizumab 1200 mg and bevacizumab 15 mg/kg will be administered intravenously on a Q3 week schedule. Subjects will start the combination of bevacizumab and atezolizumab followed by TACE treatment 4 weeks ±1 week or up to 5 weeks after study drugs. Full recovery from the procedure is required prior to systemic treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab

2013

Completed Phase 4

~5280

Transarterial chemoembolization

2019

Completed Phase 3

~1010

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,853 Previous Clinical Trials

2,738,537 Total Patients Enrolled

4 Trials studying Liver Cancer

115 Patients Enrolled for Liver Cancer

Genentech, Inc.Industry Sponsor

1,541 Previous Clinical Trials

568,119 Total Patients Enrolled

4 Trials studying Liver Cancer

140 Patients Enrolled for Liver Cancer

Stacy Stein, MDPrincipal InvestigatorYale University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers are taking part in this research endeavor?

"Correct. According to clinicaltrials.gov, this medical trial is currently recruiting patients and was originally posted on June 7th 2023. The study has since been revised as recent as September 13th 2023 and requires 24 volunteers from a single location."

Answered by AI

Has the combination of Atezolizumab, Bevacizumab and TACE been granted approval from the US Food & Drug Administration?

"From a safety standpoint, the combination of Atezolizumab and Bevacizumab with TACE registered an estimated score of 2. This is because there has been some data that affirms its safety but none to support efficacy yet in this Phase 2 trial."

Answered by AI

Are recruitment efforts still ongoing for this medical experimentation?

"Affirmative. Clinicialtrials.gov verifies that this trial, which was posted on June 7th 2023, is still recruiting patients. 24 individuals are needed from one medical facility for the completion of this project."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Atezolizumab and Bevacizumab in Combination With TACE for Patients With BCLC B HCC

2023. "Atezolizumab and Bevacizumab in Combination With TACE for Patients With BCLC B HCC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05776875.