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Monoclonal Antibodies

Atezolizumab + Bevacizumab Before Surgery for Liver Cancer

Phase 2
Recruiting
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.
Patient has histologically confirmed (if tumor tissue is unavailable, documentation of diagnosis from original biopsy is acceptable) or clinically diagnosed (American Association for the Study of Liver Disease criteria in cirrhotic subjects) hepatocellular carcinoma (HCC).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years post-treatment
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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My liver cancer diagnosis is confirmed by tests or clinical criteria.
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I can provide a tumor sample or am willing to have a biopsy for research.
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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 had an esophagus check for varices within the last 6 months.
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I have a cancer lesion that is at least 10 mm large, confirmed by imaging.
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My urine protein levels are low, under 2+ if tested with a dipstick.
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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.
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My organs and bone marrow are functioning well.
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My cancer is operable and hasn't spread beyond the liver.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events (AEs)
Pathologic complete response (pCR) rate
Secondary outcome measures
Duration of response (DOR)
Objective response rate (ORR)
Overall survival (OS)
+1 more

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227
27%
Fatigue
25%
Decreased appetite
24%
Cough
19%
Dyspnoea
19%
Asthenia
18%
Constipation
18%
Pyrexia
18%
Nausea
16%
Diarrhoea
13%
Arthralgia
12%
Vomiting
12%
Anaemia
11%
Back pain
11%
Musculoskeletal pain
11%
Rash
10%
Headache
9%
Oedema peripheral
9%
Weight decreased
9%
Chest pain
9%
Insomnia
9%
Pruritus
9%
Pain in extremity
8%
Dizziness
7%
Upper respiratory tract infection
7%
Aspartate aminotransferase increased
7%
Myalgia
7%
Haemoptysis
6%
Influenza like illness
6%
Nasopharyngitis
6%
Alanine aminotransferase increased
6%
Bronchitis
6%
Productive cough
5%
Musculoskeletal chest pain
5%
Depression
5%
Dry skin
4%
Abdominal pain
4%
Urinary tract infection
4%
Neuropathy peripheral
4%
Paraesthesia
3%
Stomatitis
3%
Dysgeusia
3%
Pneumonia
2%
Malaise
2%
Pleural effusion
2%
Neutropenia
1%
Lacrimation increased
1%
Respiratory tract infection
1%
Sepsis
1%
Pneumonitis
1%
Mucosal inflammation
1%
Bone pain
1%
Pulmonary embolism
1%
Peripheral sensory neuropathy
1%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Atezolizumab
Docetaxel

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
Bevacizumab
2013
Completed Phase 4
~5280
Atezolizumab
2016
Completed Phase 3
~6040
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9850

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,335 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

Frequently Asked Questions

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

Does using Atezolizumab pose any substantial risks to users?

"Due to the fact that this is a Phase 2 trial, with safety data present but efficacy yet to be confirmed, our team at Power assigned Atezolizumab a score of 2."

Answered by AI

What medical afflictions can be aided by the administration of Atezolizumab?

"Atezolizumab has been successfully utilised to treat non-small cell lung carcinoma, as well as recurrent platinum-sensitive epithelial ovarian cancer and postoperative recurrent cases of the same."

Answered by AI

Are there still opportunities available for people to take part in this experiment?

"Affirmative. According to clinicaltrials.gov, this study is actively enrolling patients with a posted date of February 10th 2021 and last edited on October 12th 2022. They are seeking 30 participants from two sites in total."

Answered by AI

How many people have been invited to take part in this trial?

"Affirmative. According to clinicaltrials.gov, enrollment is open for this research project which was first announced on February 10th 2021 and most recently revised on October 12th 2022. The trial requires 30 individuals across two sites."

Answered by AI

Are there any precedential studies related to Atezolizumab?

"Currently, 621 clinical trials are researching the efficacy of Atezolizumab. Of those, 142 trials have advanced to Phase 3 and they span 31793 locations worldwide with many based in Taibei, Taiwan."

Answered by AI

What are the primary aims of this medical investigation?

"This trial, which will be assessed up to two years after treatment has concluded, aims to monitor the frequency of adverse reactions. Secondary goals include observing overall survival with Kaplan-Meier methods and utilizing log-rank tests to determine a link between this metric and complete response or partial response based on RECIST 1.1/mRECIST1.0 criteria. Additionally, duration of response will also be estimated using Kaplan-Meier techniques"

Answered by AI
~15 spots leftby May 2027