Phase 2
Completed N=30
A Study of Avastin (Bevacizumab) and Transarterial Chemoembolisation (TACE) Treatment in Patients With Liver Cancer
Source: ClinicalTrials.gov NCT00576199 ↗Enrolled (actual)
30
Serious AEs
56.7%
Results posted
Aug 2014
Primary outcomePrimary: Progression-free Survival — 11.6 Months
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
11.6 | — |
| SECONDARY Percentage of Participants With an Objective Response |
23.3 | — |
| SECONDARY Time to Progression |
12.0 | — |
| SECONDARY Overall Survival |
19.9 | — |
| SECONDARY Percentage of Participants With a Best Overall Response of Complete Response, Partial Response, or Stable Disease |
86.7 | — |
| SECONDARY Tumor Necrosis |
1.3; 0.8; 1.6; 1.2; 1.0 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00576199). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.