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Monoclonal Antibodies

Atezolizumab + Bevacizumab Before Surgery for Liver Cancer

Phase 2

Waitlist Available

Led By Ahmed O Kaseb

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

ECOG (Eastern Oncology Cooperative Group) performance status ≥ 1.

Documented virology status of hepatitis, as confirmed by screening HBV and HCV tests. For patients with active HBV: HBV DNA < 500 IU/mL during screening, initiation of anti-HBV treatment at least 14 days prior to randomization and willingness to continue anti-HBV treatment during the study (per local standard of care; e.g., entecavir).

Must not have

Patient has serious cardiac disease, including New York Heart association Grade II or greater congestive heart failure, MI, unstable angina, etc.

Patient has been treated for this malignancy, has another active malignancy, or has had an active malignancy within the last two years.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years post-treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of immunotherapy and bevacizumab before surgery in treating patients with resectable liver cancer.

Who is the study for?

This trial is for adults with resectable liver cancer, who have good liver function (Child-Turcotte-Pugh score A), adequate blood counts, and no severe comorbidities. Participants must not be pregnant or breastfeeding and agree to use two forms of contraception. Exclusions include certain types of liver cancer, recent serious health events like fistulas or bleeding, uncontrolled hypertension, significant pulmonary disease, hypersensitivity to trial drugs, prior treatments for the malignancy within a specific timeframe.

What is being tested?

The study tests atezolizumab plus bevacizumab before surgery in patients with resectable hepatocellular carcinoma. It aims to see if this combination can help the immune system attack the cancer more effectively and prevent it from returning post-surgery by inhibiting tumor growth and spread.

What are the potential side effects?

Potential side effects may include reactions related to the immune system's increased activity such as inflammation in various organs; infusion-related reactions; high blood pressure due to bevacizumab; bleeding risks; fatigue; digestive issues; and an increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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I have some limitations in physical activity but can walk and take care of myself.

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I have hepatitis with controlled HBV levels and am on or willing to start treatment.

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I have a cancer lesion that is at least 10 mm large, confirmed by imaging.

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I am not breastfeeding.

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My liver function is classified as very good.

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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 a serious heart condition, such as heart failure or unstable angina.

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I have been treated for cancer, have another active cancer, or had cancer in the last 2 years.

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I have a history of blood clots, bleeding disorders, or significant blood vessel diseases.

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I have had a severe infection in the last 4 weeks.

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I have had bleeding from untreated varices in my esophagus or stomach.

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I have coughed up blood in the last 30 days.

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I have had issues like a fistula or abscess in my abdomen within the last 6 months.

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I have a serious lung condition like TB or pneumonia.

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I need regular procedures to remove fluid build-up in my body.

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My blood pressure is high (150/100 mmHg or more).

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My cancer is a specific type of liver cancer.

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I had surgery less than 6 weeks ago.

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I have had a stem cell, liver, or other organ transplant.

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I have a history of brain or spinal cord disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years post-treatment

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

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of adverse events (AEs)

Pathologic complete response (pCR) rate

Secondary study objectives

Duration of response (DOR)

Objective response rate (ORR)

Overall survival (OS)

+1 more

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227

36%

Fatigue

35%

Alopecia

24%

Diarrhoea

23%

Nausea

23%

Decreased appetite

22%

Anaemia

20%

Asthenia

19%

Cough

19%

Dyspnoea

16%

Myalgia

15%

Neutropenia

14%

Constipation

14%

Oedema peripheral

12%

Pyrexia

11%

Stomatitis

11%

Vomiting

11%

Neuropathy peripheral

10%

Arthralgia

Neutrophil count decreased

Rash

Headache

Dysgeusia

Paraesthesia

Pain in extremity

Mucosal inflammation

Back pain

Peripheral sensory neuropathy

Insomnia

Febrile neutropenia

Pneumonia

Lacrimation increased

Abdominal pain

Dry skin

Dizziness

Malaise

Urinary tract infection

Weight decreased

Haemoptysis

Nail disorder

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Productive cough

Upper respiratory tract infection

Pruritus

Influenza like illness

Alanine aminotransferase increased

Aspartate aminotransferase increased

Syncope

Dehydration

Atrial fibrillation

Lower respiratory tract infection

Lung infection

Respiratory tract infection

Acute kidney injury

Chronic obstructive pulmonary disease

Pleural effusion

Depression

Musculoskeletal chest pain

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

Awards & Highlights

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: Treatment (atezolizumab, bevacizumab)Experimental Treatment3 Interventions

Patients receive atezolizumab IV over 30-60 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery during week 12.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2016

Completed Phase 3

~5860

Bevacizumab

2013

Completed Phase 4

~5540