drugset / Trial / NCT01245582
Oxaliplatin and Capecitabine on Top of Sorafenib Versus Sorafenib Alone in Advanced Hepatocellular Carcinoma Patients
RandomizedParallel-groupOpen-labelTreatment
Summary
Primary Objective: \- To evaluate the efficacy of SECOX regimen by adding oxaliplatin plus capecitabine to sorafenib versus sorafenib alone as palliative treatment for unresectable HCC patients to prolong overall survival (OS) for advanced HCC patients. Secondary Objective: * To compare the efficacy of SECOX regimen with Sorafenib alone for progression free survival (PFS) * To compare the efficacy of SECOX regimen with Sorafenib alone for response rate (RR) * To assess the overall safety profile of SECOX regimen in comparison of Sorafenib alone
Timeline
- Start
- 2011-07
- Primary completion
- 2014-02
- Completion
- 2015-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 850 mg/m2 | Oral |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Subject | Sorafenib | Small molecule | 400 mg | Oral |