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

Phase 2

Completed

• Conditions: Liver Cancer
• Interventions: Drug: Bevacizumab; Procedure: Transarterial chemoembolisation (TACE)

• Registration Number: NCT00576199
• Lead Sponsor: Hoffmann-La Roche

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-12-18
• Study First Submitted QC: 2007-12-18
• Study First Posted: 2007-12-19
• Study Start: 2008-02
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2014-08
• Results First Submitted: 2014-08-18
• Results First Submitted QC: 2014-08-18
• Last Update Submitted: 2014-08-18
• Results First Posted: 2014-08-29
• Last Update Posted: 2014-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bevacizumab 5 mg/kg	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.
Bevacizumab 5 mg/kg	Bevacizumab	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.

Primary Outcome Measures

Name	Time	Method
Progression-free Survival	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.

Secondary Outcome Measures

Name	Time	Method
Tumor Necrosis	Baseline to the end of the study (up to 3 years, 3 months)	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.
Time to Progression	Baseline to the end of the study (up to 3 years, 3 months)	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.
Percentage of Participants With a Best Overall Response of Complete Response, Partial Response, or Stable Disease	Baseline to the end of the study (up to 3 years, 3 months)	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.
Overall Survival	Baseline to the end of the study (up to 3 years, 3 months)	Overall survival was defined as the time from the first administration of study drug to death.
Percentage of Participants With an Objective Response	Baseline to the end of the study (up to 3 years, 3 months)	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.