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

Roche

Status and phase: Completed; Phase 2

Conditions: Liver Cancer

Treatments: Drug: Bevacizumab; Procedure: Transarterial chemoembolisation (TACE)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00576199

ML21358

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Bevacizumab 5 mg/kg

Experimental group

Description:

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.

Treatment:

Drug: Bevacizumab

Procedure: Transarterial chemoembolisation (TACE)