Liver CancerPhase 2NCT00576199
A Study of Avastin (Bevacizumab) and Transarterial Chemoembolisation (TACE) Treatment in Patients With Liver Cancer
A Phase 2 study testing Bevacizumab and Transarterial chemoembolisation (TACE) in people with Liver Cancer, run by Hoffmann-La Roche at 3 sites in Hong Kong.
Trial summary
This single-arm, open-label study assessed the efficacy and safety of Avastin (bevacizumab) treatment combined with transarterial chemoembolisation (TACE) in patients with localized unresectable liver cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer
- What is being tested?
- Bevacizumab and Transarterial chemoembolisation (TACE)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesHong Kong
- Study dates
- Feb 2008to May 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients, ≥ 18 years of age.
- Liver cancer, not suitable for resection.
- At least 1 measurable lesion, and overall tumor lesions occupying < 50% of liver volume
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Who cannot join
- Patients receiving concurrent radiotherapy or immunotherapy.
- Patients who have received previous chemotherapy, biological agents, or radiotherapy.
- Prior transarterial chemoembolisation (TACE) or transarterial embolisation (TAE).
- Prior liver transplantation or liver resection.
- Current or recent (within 10 days of study start) use of full-dose anticoagulants for therapeutic purposes.
- Patients with high risk esophageal/gastric varices.
Trial locations and contacts
3 sites in 1 country.
Hong Kong3 sites
Study site
Hong Kong, 0
Study site
Hong Kong, 852
Study site
Hong Kong
About this study
Official title: A Phase II Single Arm, Multi-centre Study of Bevacizumab (Avastin®) Pre- and Post-transarterial Chemoembolisation (TACE) Treatment for Localized Unresectable Hepatocellular Carcinoma (HCC)
This single-arm, open-label study assessed the efficacy and safety of Avastin (bevacizumab) treatment combined with transarterial chemoembolisation (TACE) in patients with localized unresectable liver cancer. Patients were treated with TACE at 8 or 10 week intervals for 4 sessions (continuation depended on investigator's discretion). Avastin 5 mg/kg intravenously was administered 24-48 hours prior to each TACE session and every 2 weeks between the TACE sessions until disease progression.
- Conditions
- Liver Cancer
- Being tested
- Bevacizumab, Transarterial chemoembolisation (TACE)
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
Bevacizumab was supplied as a sterile liquid in single-use vials.
Transarterial chemoembolisation (TACE)Procedure or surgery
TACE was conducted by the transfemoral artery approach with selective cannulation of the artery supplying the tumor. Cisplatin mixed with Lipiodol in a 1 mg:1 mL ratio was infused intra-arterially up to a maximum dose of 30 mg, depending on tumor size, followed by embolization of the artery using Gelfoam particle until the blood flow slowed. Bilobar lesions were treated by separate catheterization of right and left hepatic arteries followed by injection of the cisplatin-Lipiodol mixture and embolization.
Patients with stable disease or a partial response after 4 TACE sessions could be given further TACEs upon the investigator's discretion until there was evidence of progressive disease or contraindication due to severe complication or technical failure to perform the TACE.
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab 5 mg/kg | Experimental | 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. Receives: Drug: Bevacizumab; Procedure: Transarterial chemoembolisation (TACE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
Progression-free survival was defined as the time from the first administration of study drug to the first documented disease progression or death, whichever occurs first. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.
Measured: Baseline to the end of the study (up to 3 years, 3 months)
Secondary outcomes (5)
Percentage of Participants With an Objective Response
An objective response was defined as a complete response or a partial response. A complete response was defined as the disappearance of all target lesions. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the Baseline sum longest diameter. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.
Measured: Baseline to the end of the study (up to 3 years, 3 months)
Time to Progression
Time to progression was defined as the time from the first administration of study drug to the first documented disease progression. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.
Measured: Baseline to the end of the study (up to 3 years, 3 months)
Overall Survival
Overall survival was defined as the time from the first administration of study drug to death.
Measured: Baseline to the end of the study (up to 3 years, 3 months)
Percentage of Participants With a Best Overall Response of Complete Response, Partial Response, or Stable Disease
A complete response was defined as the disappearance of all target lesions. A partial response was defined as at least a 30% decrease in the sum of the LD of target lesions taking as reference the Baseline sum LD. Stable disease was defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the LD) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the LD for all target lesions will be calculated and reported as the Baseline sum LD.
Measured: Baseline to the end of the study (up to 3 years, 3 months)
Tumor Necrosis
Tumor necrosis was quantified in liver lesions greater than 2 cm at Baseline. When MRI showed many cut surfaces for a single tumor, tumor size and the size of necrotic area was measured by accumulation of the serial sections containing the tumor. Lipiodol accumulation in tumor after TACE was regarded as an indication of necrosis. Tumor necrosis was assessed at Baseline and 1 week prior to the next scheduled transarterial chemoembolisation (TACE) for the first 4 TACEs, then 1 week prior to every second TACE till disease progression. The extent of tumor necrosis is presented as the percentage of the tumor volume at Baseline.
Measured: Baseline to the end of the study (up to 3 years, 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2007 (estimated)
- Study startFeb 2008
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00576199
- Sponsor's protocol ID
- ML21358
- Status last verified
- Aug 2014
- First submitted
- 18 Dec 2007
- Last updated
- 29 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Single Arm, Multi-centre Study of Bevacizumab (Avastin®) Pre- and Post-transarterial Chemoembolisation (TACE) Treatment for Localized Unresectable Hepatocellular Carcinoma (HCC)
- ClinicalTrials.gov ID
- NCT00576199
- Acronym / sponsor ID
- ML21358
- Conditions
- Liver Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 19 Dec 2007 (estimated)
- Results
- Posted 29 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single-arm, open-label study assessed the efficacy and safety of Avastin (bevacizumab) treatment combined with transarterial chemoembolisation (TACE) in patients with localized unresectable liver cancer. Patients were treated with TACE at 8 or 10 week intervals for 4 sessions (continuation depended on investigator's discretion). Avastin 5 mg/kg intravenously was administered 24-48 hours prior to each TACE session and every 2 weeks between the TACE sessions until disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab 5 mg/kg | Experimental | Drug: Bevacizumab, Procedure: Transarterial chemoembolisation (TACE)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients, ≥ 18 years of age.
- Liver cancer, not suitable for resection.
- At least 1 measurable lesion, and overall tumor lesions occupying < 50% of liver volume
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Key exclusion criteria (6 listed)
- Patients receiving concurrent radiotherapy or immunotherapy.
- Patients who have received previous chemotherapy, biological agents, or radiotherapy.
- Prior transarterial chemoembolisation (TACE) or transarterial embolisation (TAE).
- Prior liver transplantation or liver resection.
- Current or recent (within 10 days of study start) use of full-dose anticoagulants for therapeutic purposes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabAlso: AvastinBevacizumab was supplied as a sterile liquid in single-use vials. | Drug | Bevacizumab 5 mg/kg |
| Transarterial chemoembolisation (TACE)TACE was conducted by the transfemoral artery approach with selective cannulation of the artery supplying the tumor. Cisplatin mixed with Lipiodol in a 1 mg:1 mL ratio was infused intra-arterially up to a maximum dose of 30 mg, depending on tumor size, followed by embolization of the artery using Gelfoam particle until the blood flow slowed. Bilobar lesions were treated by separate catheterization of right and left hepatic arteries followed by injection of the cisplatin-Lipiodol mixture and embolization. Patients with stable disease or a partial response after 4 TACE sessions could be given further TACEs upon the investigator's discretion until there was evidence of progressive disease or contraindication due to severe complication or technical failure to perform the TACE. | Procedure or surgery | Bevacizumab 5 mg/kg |
Primary outcome
Progression-free Survival
Time frame: Baseline to the end of the study (up to 3 years, 3 months)
Progression-free survival was defined as the time from the first administration of study drug to the first documented disease progression or death, whichever occurs first. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.
5 secondary outcomes
Percentage of Participants With an Objective Response
Time frame: Baseline to the end of the study (up to 3 years, 3 months)
Time to Progression
Time frame: Baseline to the end of the study (up to 3 years, 3 months)
Overall Survival
Time frame: Baseline to the end of the study (up to 3 years, 3 months)
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)
Tumor Necrosis
Time frame: Baseline to the end of the study (up to 3 years, 3 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab and Transarterial chemoembolisation (TACE) in people with Liver Cancer, run by Hoffmann-La Roche at 3 sites in Hong Kong.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 29 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hong Kong. 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. 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?
Yes. Results are posted in the registry (first posted 29 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression-free Survival (time frame: Baseline to the end of the study (up to 3 years, 3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2014.