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

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Bevacizumab

Criteria

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.