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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

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 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
9%
Neutrophil count decreased
9%
Rash
8%
Headache
8%
Dysgeusia
8%
Paraesthesia
7%
Pain in extremity
7%
Mucosal inflammation
7%
Back pain
7%
Peripheral sensory neuropathy
7%
Insomnia
6%
Abdominal pain
6%
Febrile neutropenia
6%
Lacrimation increased
6%
Dry skin
6%
Pneumonia
6%
Dizziness
5%
Malaise
5%
Urinary tract infection
5%
Weight decreased
5%
Haemoptysis
5%
Nail disorder
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
4%
Productive cough
3%
Upper respiratory tract infection
3%
Pruritus
2%
Influenza like illness
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
1%
Syncope
1%
Dehydration
1%
Atrial fibrillation
1%
Lower respiratory tract infection
1%
Lung infection
1%
Respiratory tract infection
1%
Acute kidney injury
1%
Chronic obstructive pulmonary disease
1%
Pleural effusion
1%
Depression
1%
Musculoskeletal chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab

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
2017
Completed Phase 3
~5850
Bevacizumab
2013
Completed Phase 4
~5540
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9870

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,685 Total Patients Enrolled
22 Trials studying Liver Cancer
9,411 Patients Enrolled for Liver Cancer
Ahmed O KasebPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
82 Total Patients Enrolled

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04721132 — Phase 2
Liver Cancer Research Study Groups: Treatment (atezolizumab, bevacizumab)
Liver Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT04721132 — Phase 2
Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04721132 — Phase 2
~7 spots leftby May 2027
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