Study in Asia of the combination of transcatheter arterial chemoembolization (TACE) with sorafenib in patients with hepatocellular carcinoma (HCC) trial (START): Second interim safety and efficacy analysis
| Autor: | J. Wang, Y. Chao, B. Kim, K. Seetalarom, T. Lee, C. Li, C. Chen, S. Bae, Y. Chung, H. Chu, J. Yoon |
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| Rok vydání: | 2010 |
| Předmět: |
Sorafenib
Oncology Cancer Research medicine.medical_specialty business.industry medicine.medical_treatment Interim analysis medicine.disease Tolerability Internal medicine Hepatocellular carcinoma medicine Lipiodol Clinical endpoint Embolization business Transcatheter arterial chemoembolization medicine.drug |
| Zdroj: | Journal of Clinical Oncology. 28:4026-4026 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2010.28.15_suppl.4026 |
| Popis: | 4026 Background: We report the second interim analysis of START. Methods: START is a phase II, multicenter, open-label, single-arm study being conducted in Asia Pacific. Patients with unresectable, intermediate-stage HCC (BCLC B), and who are candidates for TACE are eligible. Patients receive TACE with lipiodol and doxorubicin (30-60 mg), followed by embolization with absorbable particles. Sorafenib 400mg bid is given continuously, with dose interruptions 4 days before and after TACE, which is performed every 6-8 weeks. Tumor response is assessed every 4 weeks after every TACE. Patients continue sorafenib until disease progression or unacceptable toxicity, even after stopping TACE due to complete response (CR) or inability to continue to receive TACE. The primary endpoint is safety/tolerability. Secondary endpoints include progression-free survival, time to progression, overall survival, and number of TACE cycles. Results: 63 patients were evaluable for safety, and 50 for efficacy. For analysis of efficac... |
| Databáze: | OpenAIRE |
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