| General information |
| Database: | DB00879 |
| Objective: | Molecularly targeted agents with antiangiogenic activity, including bevacizumab, have demonstrated clinical activity in patients with advanced/metastatic hepatocellular carcinoma (hepatocellular carcinoma). This multicentrephase II study involving patients from several Asian countries sought to evaluate the safety and efficacy of bevacizumab plus capecitabine in this population |
| Authors: | Hsu CH, et al |
| Title: | Efficacy and tolerability of bevacizumab plus capecitabine as firstline therapy in patients with advanced hepatocellular carcinoma. |
| Journal: | Br J Cancer. |
| Year: | 2010 |
| PMID: | 20160718 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | bevacizumab
|
| Target: | Vascular endothelial growth factor
|
| Cancer Type: | liver cancer |
| Cancer Subtype: | advanced hepatocellular carcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | bevacizumab + capecitabine |
| Study Type: | multicentrephase II study |
| Key Patients Feature: | Histologically proven/clinically diagnosed advanced hepatocellular carcinoma patients |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | pts received bevacizumab 7.5 mg kg(1) on day 1 and capecitabine 800 mg m(2) twice daily on days 114 every 3 weeks as firstline therapy. |
| Primary End Point: | safety and efficacy |
| Secondary End Point: | NA |
| Patients Number: | 45 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 9% |
| Disease Control Rate: | 9% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 2.7 months (95% CI: 1.5-4.1 months) in the intenttotreat population |
| Median OS A vs. C: | 5.9 months (95% CI: 4.1-9.7 months) in the intenttotreat population |
| Adverse Event(agent arm): | Treatmentrelated grade 3/4 toxicities were diarrhoea (n=2, 4%), nausea/vomiting (n=1, 4%), gastrointestinal bleeding (n=4, 9%, including three patients with oesophageal variceal bleeding), hand-foot syndrome (n=4, 9%), lotheyr respiratory tract infection (n=1, 2%) and proteinuria (n=1, 2%). |
| Conclusions: | The bevacizumabcapecitabine combination shows good tolerability and modest antitumour activity in patients with advanced hepatocellular carcinoma. |