Entry Detail
| General information | |
| Database: | DB00924 |
| Objective: | Sorafenib has proven survival benefits in patients with advanced hepatocellular carcinoma (hepatocellular carcinoma). The viability of continuing sorafenib at a higher dosage in patients who experienced radiologic disease progression was investigated. |
| Authors: | Rimassa L, et al |
| Title: | a phase II randomized dose escalation trial of sorafenib in patients with advanced hepatocellular carcinoma. |
| Journal: | Oncologist. |
| Year: | 2013 |
| PMID: | 23580239 |
| Trial Design | |
| Clinical Trial Id: | NCT00490685 |
| Agent: | sorafenib |
| Target: | Vascular endothelial growth factor receptor 1 BRaf protooncogene serine/threonineprotein kinase Protooncogene tyrosineprotein kinase receptor ret |
| Cancer Type: | liver cancer |
| Cancer Subtype: | advanced hepatocellular carcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a phase II randomized dose escalation trial |
| Key Patients Feature: | Patients with advanced hepatocellular carcinoma who experienced disease progression while on sorafenib 400 mg twice daily |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | pts were randomized to sorafenib 600 mg twice daily (n = 49) or best supportive care (n = 52). |
| Primary End Point: | an improvement in overall survival (OS) between the treatment arms. |
| Secondary End Point: | NA |
| Patients Number: | 101 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | The difference in PFS between the sorafenib arm (3.91 months) and the best supportive care arm (2.69 months) did not reach statistical significance (p = 0.086). |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | Adverse events were mainly grade 1-2 and similar across both groups. In the sorafenib arm, the most frequent events were diarrhea (80%), weight loss (75%), fatigue (67%), handfootskin reaction (49%), abdominal pain (37%), and stomatitis (26%). |
| Conclusions: | Escalateddose sorafenib in patients with advanced hepatocellular carcinoma who progressed while on sorafenib, failed to provide any clinical benefit. Secondline treatment still remains an open issue to be explored in appropriate clinical trials |