drugset / Trial / NCT00808145
Study of Sorafenib, Gemcitabine, and Cisplatin in Advanced Hepatocellular Carcinoma (HCC)
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This study will look at the safety and efficacy of treating advanced hepatocellular carcinoma in patients who have not yet received systemic chemotherapy. Previous local treatment of hepatic lesions is permitted The treatment will use a combination of three FDA approved chemotherapy drugs, Gemcitabine, Cisplatin and Sorafenib. Sorafenib is FDA approved for the treatment of hepatocellular cancer, gemcitabine and cisplatin are not approved for the treatment of hepatocellular cancer.
Timeline
- Start
- 2009-02
- Primary completion
- 2014-10
- Completion
- 2014-10
Outcome
Outcome not reported
Stopped (Enrollment): “Lack of enrollment, many screen failures and non eligible study participants”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 30 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | Sorafenib | Small molecule | 400 mg | Oral |