Bevacizumab for Carcinoma, Hepatocellular

Phase-Based Estimates
1
Effectiveness
2
Safety
University of Illinois Cancer Center, Chicago, IL
Carcinoma, Hepatocellular+2 More
Bevacizumab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Carcinoma, Hepatocellular

Study Summary

This study is evaluating whether a combination of two medications may be safe for individuals with liver cancer.

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Eligible Conditions

  • Carcinoma, Hepatocellular
  • Carcinoma
  • Unresectable Hepatocellular Carcinoma (HCC)

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Bevacizumab will improve 1 primary outcome and 5 secondary outcomes in patients with Carcinoma, Hepatocellular. Measurement will happen over the course of 1 year.

1 year
Disease control rate (DCR)
Duration of response (DOR)
Frequency and severity of toxicities
Median overall survival (OS)
Median progression-free survival (PFS)
Overall response rate (ORR)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
Study Treatment

This trial requires 50 total participants across 2 different treatment groups

This trial involves 2 different treatments. Bevacizumab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Study TreatmentAtezolizumab 1,200 mg IV and bevacizumab 15 mg/kg IV every 3 weeks (on day 1 of each 21-day cycle). Treatment will continue until disease progression or development of unacceptable toxicity.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
FDA approved
Bevacizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year for reporting.

Closest Location

University of Illinois Cancer Center - Chicago, IL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Histologically proven locally advanced, metastatic, or unresectable hepatocellular carcinoma that has not received prior systemic therapy. Note: if no prior histologic diagnosis exists, fresh biopsy will be requested if it is both safe and feasible. If fresh biopsy is not safe and feasible, imaging criteria may be used for diagnosis as per AASLD criteria in cirrhotic patients (please see www.aasld.org for up to date guidelines).
At least 1 untreated measurable lesion according to RECIST 1.1.
Willingness to undergo fresh tumor biopsy at baseline if safe and feasible. Note: archival tissue may be used at baseline provided histologic diagnosis was made and sufficient tissue is available for NGS analysis.
Written informed consent and HIPAA authorization for release of personal health information must be obtained either from the subject or their representative. See 3.1.12. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
Age ≥ 18 years at the time of consent.
ECOG Performance Status of 0-1.
NGS analysis must be requested from archival tissue or fresh biopsy (if applicable) as per standard of care. Foundation One CDX is the preferred platform. Prior NGS sequencing results (including from another platform) will be accepted if both histologic diagnosis and NGS sequencing were previously obtained (please see protocol).
Demonstrate adequate bone marrow and organ function as defined in the table in the protocol
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab, or 6 months after the last dose of bevacizumab. See also the protocol for definition of childbearing potential.
Child Pugh Class B7 liver dysfunction or cirrhosis (please see Appendix 3). Note: patients with clinically meaningful ascites or encephalopathy are ineligible (please see protocol).

Patient Q&A Section

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

What are the signs of carcinoma, hepatocellular?

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Cirrhosis causes abdominal pain and enlargement of the liver, which may be an early sign of a malignancy. Patients should undergo biopsy if the signs of liver disease persist for more than 3 months.

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How many people get carcinoma, hepatocellular a year in the United States?

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1.0 million people in the U.S. will be diagnosed with carcinoma, hepatomeglial in 2050. 2.0 million will be diagnosed with hepatocellular carcinoma in 2050. 3.0 million with hepatocellular Carcinoma in 2050.

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What is carcinoma, hepatocellular?

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A diagnosis of carcinoma of the liver may be associated with either cirrhosis or cirrhosis without proof of cirrhosis and with less than three other causes of cirrhosis. It is associated with a longer latency to development of cirrhosis and with a shorter lifespan than other cirrhis. The occurrence of hepatocarcinoma is less likely in the presence of hepatitis C or alcohol abuse. A history of occupational exposure to pesticides or to solvents may increase the risk, although this finding is inconsistent.

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What are common treatments for carcinoma, hepatocellular?

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There is no cure for HCC. Most treatment is aimed at symptom and quality of life management.\nquestion: Is combination therapy superior to monotherapy in NSCLC patients with EGFR mutations? answer: Treatment with an EGFR inhibitor as a single agent or in combination with chemotherapy is not superior to chemotherapy alone in stage III NSCLC patients with a good performance status with EGFR S1069T mutation. A prospective clinical trial is warranted.

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What causes carcinoma, hepatocellular?

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Results from a recent clinical trial supports the hypothesis that cirrhosis and bile duct tumors increase risk for HCC; we could not validate an effect for adenoma and HCC in the general population. We found that in HCC and HCCL the use of alcohol decreased risk, whereas in HCCS that risk was increased. Furthermore, the association of HCC with diabetes mellitus was also confirmed by this study.

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Can carcinoma, hepatocellular be cured?

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Liver carcinoma has a poor prognosis after curative operation. However, most patients have a good prognosis when they tolerate the operation and have no residual disease after it has disappeared. The disease is rarely curable, although many patients have a good long term prognosis. But the long term prognosis of patients after partial hepatectomy remains obscure.

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What is the primary cause of carcinoma, hepatocellular?

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  1. The primary cause of carcinoma, hepatocellular is not HCV infection. 2. HCV is not the cause of all HCV-related cancer; other factors are involved such as genetics; and the environment in the HCV-endemic nation is very different from the country of Kuwait. 3. HCV infection may cause carcinoma, hepatocellular in some patients. What are the other causes of carcinoma, hepatocellular? answer: [Withdrawal of HCV from the bloodstream should be considered the primary cause of carcinoma, hepatocellular in the Kuwaiti population.
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Have there been any new discoveries for treating carcinoma, hepatocellular?

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To date, the majority of the new discoveries concerning the treatment of carcinoma are from animal experiments. There is no doubt that animal experiments are a great place to begin our investigations.

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What are the common side effects of bevacizumab?

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Bevacizumab is associated with a set of side effects that is often manageable. In contrast to the common adverse reactions to many new drugs, bevacizumab is not associated with a high or unexpected occurrence of common adverse events.

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What are the latest developments in bevacizumab for therapeutic use?

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Results from a recent clinical trial reflect the growing use of bevacizumab that was reported as of 2009 by the FDA to treat a range of malignancies, but recent reports have additionally shown bevacizumab to have potentially beneficial (even antitumorigenic in some tumors) effects outside its traditional indication in metastatic or recurrent breast cancer.

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What does bevacizumab usually treat?

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This case confirms that systemic metastatic hepatocellular cancer has aggressive behavior. Bevacizumab improved outcomes in all patients. Treatment of locally advanced hepatic metastases may be an option following chemotherapy.

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How does bevacizumab work?

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Bevacizumab decreases the number of circulating endothelial cells in patients with recurrent, first recurrence of breast cancer, and in patients with HCC. Bevacizumab also decreases vascular permeability and lowers blood levels of circulating VEGF, which suggests that this drug may reduce inflammation in conjunction with its antiangiogenic effect.

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