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Monoclonal Antibodies

SBRT + Atezolizumab + Bevacizumab for Liver Cancer

Phase < 1

Recruiting

Led By Joseph W Franses, MD, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

Age ≥18 years at the time of signing the informed consent document

No prior therapy directed against the index hepatocellular carcinoma lesion

Must not have

History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screen chest computed tomography (CT) scan

Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment to end of treatment, up to 2 years

Awards & highlights

Summary

This trial is looking at how well neoadjuvant SBRT (a type of radiation therapy) with atezolizumab and bevacizumab (two cancer-fighting drugs) work in treating resectable hepatocellular carcinoma (a type of liver cancer). Researchers want to see if this neoadjuvant therapy combination is safe and tolerable.

Who is the study for?

This trial is for adults with resectable hepatocellular carcinoma (a type of liver cancer) who have good liver function (Child-Pugh A), no history of certain bleeding events or severe allergies, and are not pregnant. They must be able to understand the study and consent to it, have measurable disease without vascular invasion, and agree to use contraception.

What is being tested?

The trial tests the combination of SBRT (a precise form of radiation therapy), Atezolizumab, Bevacizumab, followed by surgery in patients with resectable liver cancer. It aims to assess how safe this treatment sequence is and how well patients tolerate it.

What are the potential side effects?

Possible side effects include high blood pressure from Bevacizumab; immune-related reactions like inflammation or infusion reactions from Atezolizumab; fatigue; risk of infection; potential damage to nearby organs from SBRT.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have not received any treatment for my liver cancer lesion.

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I have a tumor that can be measured and is at least as big as specified.

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I have not received any treatment for my liver cancer lesion.

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I have a tumor that can be measured with imaging or physical exam.

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I am HIV-positive, on treatment, and my viral load has been undetectable for 6 months.

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My liver cancer is operable and hasn't spread into major blood vessels.

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My heart condition is stable or mild.

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My liver functions well despite my condition.

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I can carry out all my self-care but cannot do heavy physical work.

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I am mostly self-sufficient and can carry out daily activities.

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My liver functions well despite my condition.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had lung conditions like pulmonary fibrosis or pneumonitis.

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I have a serious wound that won't heal, an active ulcer, or an untreated broken bone.

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I have unexplained air in my abdomen not due to recent procedures.

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I have had a severe hypertension crisis or brain issues due to high blood pressure.

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I have active tuberculosis.

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I haven't had major surgery in the last 4 weeks and don't expect to need one during the study.

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I do not have cancer that has spread to my brain or other distant parts of my body.

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I am currently on or recently used blood thinners for treatment.

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My cancer has spread to lymph nodes or other areas beyond the liver.

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My liver cancer is a specific type: fibrolamellar, sarcomatoid, or mixed.

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I am currently taking or have recently taken high-dose aspirin or certain blood thinners.

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I haven't had major surgery or serious injury in the last 28 days, or abdominal surgery or injury in the last 60 days.

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I have had a blockage in my intestines before.

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I take NSAID medication every day for a chronic condition.

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My high blood pressure is not well controlled.

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I have untreated or partially treated varices in my esophagus or stomach that may bleed.

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I haven't had major heart problems in the last 3 months.

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I have had or am waiting for a stem cell or organ transplant.

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I haven't had any major stomach or throat issues in the last 6 months.

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I have had severe liver-related brain issues or fluid in my abdomen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment to end of treatment, up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment to end of treatment, up to 2 years

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of patients with grade 3-4 treatment-related adverse events as assessed by CTCAE v5.0

Secondary study objectives

Complete response (CR)

Objective response rate (ORR)

Overall survival (OS)

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Stereotactic beam radiation therapy (SBRT) +Atezolizumab + BevacizumabExperimental Treatment3 Interventions

Participants will: * undergo a pre-treatment biopsy with fiducial marker placement * receive Stereotactic beam radiation therapy (SBRT) on three treatment days which will be arranged on an every-other-day basis * receive two 3-week (21 days) cycles of atezolizumab plus bevacizumab * receive Atezolizumab on day 1 for 2 study cycles. * receive Bevacizumab 1x weekly for 2 study cycles * Surgery after SBRT and the two cycles of atezolizumab and bevacizumab, unless participants are otherwise informed by their doctor. The planned surgery will take place 6-8 weeks after the last infusions of atezolizumab and bevacizumab.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2017

Completed Phase 3

~5850

Bevacizumab

2013

Completed Phase 4

~5540

0 / 33Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,993 Previous Clinical Trials

13,230,701 Total Patients Enrolled

6 Trials studying Liver Cancer

562 Patients Enrolled for Liver Cancer

Genentech, Inc.Industry Sponsor

1,550 Previous Clinical Trials

568,344 Total Patients Enrolled

4 Trials studying Liver Cancer

140 Patients Enrolled for Liver Cancer

Joseph W Franses, MD, PhDPrincipal InvestigatorMassachusetts General Hospital

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04857684 — Phase < 1

Liver Cancer Research Study Groups: Stereotactic beam radiation therapy (SBRT) +Atezolizumab + Bevacizumab

Liver Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT04857684 — Phase < 1

Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04857684 — Phase < 1

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