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Hepatocellular CarcinomaPhase 2NCT00280007

Transarterial Chemoembolisation Plus Bevacizumab for Treatment of Hepatocellular Carcinoma

A Phase 2 study testing bevacizumab in people with Hepatocellular Carcinoma, run by Medical University of Vienna at 1 site in Austria.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Patients with liver cirrhosis and hepatocellular carcinoma will undergo transarterial chemoembolisation (TACE) as clinically indicated and will be randomized to receive bevacizumab or placebo every 2 weeks up to 1 year. Tumor response will be assessed using MR of the liver and PET-scanning. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
1 siteAustria
Study dates
Jan 2006to Dec 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with histologically confirmed HCC not suitable for OLT or resection (>3 nodules, >5 cm diameter, vascular invasion, clinically significant portal hypertension, other contraindications against OLT) or patients awaiting OLT with an expected waiting time >12 months
  • Child-Pugh Stage A and B
  • Liver disease of any etiology
  • Written informed consent (approved by the Institutional Review Board [IRB]/Independent Ethics Committee [IEC]) obtained prior to any study specific screening procedures
  • Patient must be able to comply with the protocol
  • Age ≥18 years
Show all 18Show fewer
  • Women of childbearing potential must have a negative serum pregnancy test done 1 week prior to the administration of the study drug. Fertile women and men of childbearing potential (<2 years after last menstruation in women) must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile)
  • Proteinuria at baseline:
  • Urine dipstick of proteinuria <2+. Patients discovered to have >2+ proteinuria on dipstick urinalysis at baseline, should undergo a 24-hour urine collection and must demonstrate less <= 1 g of protein/24 hr.
  • Haematology:
  • Absolute neutrophil count (ANC) > 1 x 109/L
  • Platelet count > 40 x 109/L
  • Haemoglobin > 9 g/dL (may be transfused to maintain or exceed this level)
  • Prothrombin time >= 40%
  • Biochemistry:
  • Total bilirubin <= 5 mg/dL
  • Serum creatinine < 3.0 mg/dL
  • Life expectancy of >3 months

Who cannot join

  • extra hepatic tumor spread
  • complete portal vein thrombosis (common trunk)
  • Child-Pugh-Stage C
  • Prior TACE or TAE
  • Other experimental therapies for HCC
  • Acute variceal bleeding within the last 2 weeks
Show all 19Show fewer
  • Large oesophageal varices (>5 mm diameter) without prophylactic band ligation
  • Past or current history (within the last 2 years prior to randomisation) of malignancies except for the indication under this study and curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix
  • History or evidence upon physical examination of CNS disease unless adequately treated (e.g., seizure not controlled with standard medical therapy or history of stroke within < 6 months), excluding hepatic encephalopathy
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study
  • Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants for therapeutic purposes
  • Chronic, daily treatment with aspirin (>325mg/day)
  • Pregnancy (positive serum pregnancy test) or lactation
  • Uncontrolled hypertension
  • Serious, non-healing wound, ulcer, or bone fracture
  • Patients with known allergy to Chinese hamster ovary cell proteins or other recombinant human or humanized antibodies or to any excipients of Bevacizumab formulation; or to any other study drugs
  • Currently or recent (within the 30 days prior to starting study treatment) treatment of another investigational drug or participation in another investigational study
  • Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (≤ 6 months prior to randomisation), myocardial infarction (≤ 6 months prior to randomisation), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication
  • Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complications

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Medizinische Universität Wien

    Vienna, A-1090

Other trials in Austria

About this study

Official title: AVATACE-1: Bevacizumab (Avastin®) as Inhibitor of Collateral Tumor Vessel Growth During Transarterial Chemoembolisation (TACE) for Hepatocellular Carcinoma (HCC) a Pilot Trial

Patients with liver cirrhosis and hepatocellular carcinoma will undergo transarterial chemoembolisation (TACE) as clinically indicated and will be randomized to receive bevacizumab or placebo every 2 weeks up to 1 year. Tumor response will be assessed using MR of the liver and PET-scanning.

It will be tested whether the addition of bevacizumab as angiogenic inhibitor will slow down tumor progression, reduce the need for re-embolisation and will improve patient survival.

Read the detailed description

TACE is an established therapy for patients with advanced stage HCC not amenable to liver transplantation or resection and has been shown to significantly improve survival in these patients compared to no treatment (8). TACE takes advantage of the predominantly arterial blood supply of malignant liver tumors contrary to the surrounding normal liver tissue, which receives more blood supply through the portal venous system.

TACE leads to predictable tumor necrosis until new blood vessels grow into the tumor margins to support tumor growth. Quite often after cutting off the blood supply through the hepatic artery, the tumor induces active angiogenesis to promote collateral blood vessel growth from liver capsule arteries or collaterals from the gastroduodenal artery. VEGF seems to be an important player in inducing this angiogenetic activity and tumor control and survival of patients after TACE have been linked to serum VEGF-levels with higher levels showing reduced survival.

Inhibition of these neoangiogenetic activity could lead to significantly improved in tumor control and survival in patients with advanced stage HCC.

  1. STUDY OBJECTIVE
  • to assess the effectiveness of bevacizumab in combination with TACE as measured by patients without tumor progression on MRT after 3 cycles of TACE as well as the number of TACE cycles applied for recurrent tumor after a maximum of one year treatment with bevacizumab
  • to assess collateral tumor vessel growth on MRT / CT
Being tested
bevacizumab
Keywords
hepatocellular carcinoma, TACE, transarterial chemoembolisation, portal hypertension, angiogenesis, VEGF, bevacizumab
Medical subject headings
Carcinoma, Hepatocellular, Hypertension, Portal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bevacizumabDrug

    Also called -avastin

    bevacizumab 5 mg/kg i.v. every 14 days for 52 weeks

Study groups in NCT00280007
Study groupRoleWhat they receive
1Experimentalbevacizumab infusion evey 2 weeks
Receives: Drug: bevacizumab
2Placebo comparatorplacebo infusion
Receives: Drug: bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. to assess the effectiveness of bevacizumab in combination with TACE as measured by patients without tumor progression after a maximum of one year treatment with bevacizumab

    Measured: 12 months

  2. to assess collateral tumor vessel growth on MRT / CT after 3, 6, and 12 months

    Measured: 12 months

Secondary outcomes (9)

  1. overall survival

    Measured: 12 months

  2. time to progression

    Measured: 12 months

  3. safety

    Measured: 12 months

  4. total number of TACE-cycles applied

    Measured: 12 months

  5. metabolically active tumor size on PET-scan

    Measured: 12 months

  6. circulating endothelial progenitors and pro-angiogenic hematopoietic cells as markers of angiogenesis

    Measured: 12 months

  7. HGF-levels during therapy

    Measured: 12 months

  8. portal hypertension and systemic hemodynamics

    Measured: 12 months

  9. cost

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2006 (estimated)
  2. Study startJan 2006
  3. Primary completionDec 2009 (estimated)
  4. Study completionDec 2010 (estimated)

Why it stopped: Safety concerns in the treatment arm

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00280007
Sponsor's protocol ID
MPR-2
Status last verified
Sep 2009
First submitted
19 Jan 2006
Last updated
22 Apr 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bevacizumab in people with Hepatocellular Carcinoma, run by Medical University of Vienna at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Safety concerns in the treatment arm). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

to assess the effectiveness of bevacizumab in combination with TACE as measured by patients without tumor progression after a maximum of one year treatment with bevacizumab (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00280007.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2010.

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