A Study of Avastin (Bevacizumab) and Transarterial Chemoembolisation (TACE) Treatment in Patients With Liver Cancer

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition:	Liver Cancer
Interventions:	Drug: Bevacizumab; Procedure: Transarterial chemoembolisation (TACE)

  Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The Participant Flow data are discontinuations from bevacizumab treatment. Data for discontinuations from the study are not available.

Reporting Groups

	Description
Bevacizumab 5 mg/kg	Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.

Participant Flow:   Overall Study

	Bevacizumab 5 mg/kg
STARTED	30
COMPLETED	0
NOT COMPLETED	30
Adverse Event	12
Insufficient Therapeutic Response	14
Refused Treatment	2
Reason Unspecified	2

  Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat population: All participants who received study medication.

Reporting Groups

	Description
Bevacizumab 5 mg/kg	Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.

Baseline Measures

	Bevacizumab 5 mg/kg
Overall Participants Analyzed; [Units: Participants]	30
Age; [Units: Years]; Mean (Standard Deviation)	62.8 (10.43)
Gender; [Units: Participants]
Female	4
Male	26

  Outcome Measures

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1. Primary:

Progression-free Survival [ Time Frame: Baseline to the end of the study (up to 3 years, 3 months) ]

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2. Secondary:

Percentage of Participants With an Objective Response [ Time Frame: Baseline to the end of the study (up to 3 years, 3 months) ]

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3. Secondary:

Time to Progression [ Time Frame: Baseline to the end of the study (up to 3 years, 3 months) ]

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4. Secondary:

Overall Survival [ Time Frame: Baseline to the end of the study (up to 3 years, 3 months) ]

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5. Secondary:

Percentage of Participants With a Best Overall Response of Complete Response, Partial Response, or Stable Disease [ Time Frame: Baseline to the end of the study (up to 3 years, 3 months) ]

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6. Secondary:

Tumor Necrosis [ Time Frame: Baseline to the end of the study (up to 3 years, 3 months) ]

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  Serious Adverse Events

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  Other Adverse Events

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  Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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Certain Agreements:  

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is: The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo. The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.; Restriction Description: The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

Results Point of Contact:  

Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800 821-8590

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00576199 History of Changes
Other Study ID Numbers:	ML21358
First Submitted:	December 18, 2007
First Posted:	December 19, 2007
Results First Submitted:	August 18, 2014
Results First Posted:	August 29, 2014
Last Update Posted:	August 29, 2014