← Back to Search

Monoclonal Antibodies

Atezolizumab + Bevacizumab + SBRT for Liver Cancer

Phase 1

Recruiting

Led By Jennifer Y Wo, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

ECOG performance status 0-1

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

Must not have

Inadequately controlled arterial hypertension

Uncontrolled intercurrent illness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2.5 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is looking at the safety and tolerability of the two drugs in combination with SBRT for treating unresectable hepatocellular carcinoma.

Who is the study for?

This trial is for adults with unresectable hepatocellular carcinoma (liver cancer), who have not had certain prior treatments, and whose liver function is relatively preserved (Child-Pugh A). They should have no more than 5 liver lesions, no severe portal hypertension or significant heart disease, and must not be pregnant or breastfeeding. Contraception use is required for participants of childbearing potential.

What is being tested?

The study tests the combination of atezolizumab and bevacizumab drugs with stereotactic body radiation therapy (SBRT) to see if it's safe and tolerable for treating liver cancer that can't be removed by surgery. Participants will receive these medications alongside targeted radiation treatment.

What are the potential side effects?

Potential side effects include high blood pressure, bleeding or bruising easily due to low platelet counts, fatigue, protein in urine, poor appetite, diarrhea; rare but serious risks involve gastrointestinal perforations and wound healing complications.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am fully active or can carry out light work.

Select...

I am 18 years old or older.

Select...

I don't have high blood pressure in the liver veins.

Select...

My organ and bone marrow functions are within normal ranges.

Select...

My liver cancer cannot be treated with surgery, transplant, or RFA.

Exclusion Criteria

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

Select...

My high blood pressure is not well controlled.

Select...

I do not have any unmanaged ongoing illnesses.

Select...

I am currently taking or have recently taken certain medications.

Select...

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

Select...

I have pain from my cancer that isn't managed well.

Select...

I have high calcium levels in my blood that are causing symptoms.

Select...

My cancer has spread directly into nearby organs.

Select...

I have not had any cancer other than liver cancer in the last 5 years.

Select...

I have a bleeding or clotting issue that needs treatment.

Select...

I have varices that are at high risk of bleeding or have bled.

Select...

I have a history of lung conditions.

Select...

I have not had major surgery recently.

Select...

I have received systemic therapy before.

Select...

My cancer has spread outside the liver or I have cancerous nodes larger than 2 cm.

Select...

I have active tuberculosis.

Select...

I have brain metastases that are untreated or getting worse.

Select...

I frequently need procedures to remove excess fluid from my chest or abdomen.

Select...

I have had a stem cell or organ transplant in the past.

Select...

I have moderate to severe fluid buildup in my abdomen.

Select...

I have a serious heart or blood vessel condition.

Select...

My liver cancer is of a specific type.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2.5 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

Dose Limiting Toxicity Rate

Secondary study objectives

Change in Child-Pugh Score

In-field response rate

Out of field response rate

+2 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

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

Study will begin with a safety lead of 6 participants to determine the maximum tolerated dose (MTD) of Stereotactic beam radiation therapy (SBRT) with atezolizumab and bevacizumab followed by study expansion to 14 more participants after maximum tolerated dose (MTD) is established. Safety Lead-In: 6 cycles/18 weeks (study cycle is 3 weeks/21 days) * Cycle 1: Atezolizumab + Bevacizumab (1x) with Stereotactic beam radiation therapy (SBRT) every 1-3 days * Cycles 2-6: Atezolizumab + Bevacizumab (1x) every 3 weeks Expanded Study: * Cycle 1: Atezolizumab + Bevacizumab (1x) with Stereotactic beam radiation therapy (SBRT) every 1-3 days * Cycles 2-End:Atezolizumab + Bevacizumab (1x) every cycle

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

FDA approved

Bevacizumab

FDA approved

0 / 26Eligibility criteria met