drugset / Trial / NCT01131689
Trial of S-1 in Combination With Sorafenib for Patients With Advanced Hepatocellular Carcinoma
Non-randomizedSingle-groupOpen-labelTreatment
Summary
In preclinical studies, 5-fluorouracil, one of the active metabolites of S-1, showed synergistic effect to sorafenib in human colon carcinoma cell lines. Therefore, sorafenib combined with S-1 might be more effective treatment for patients with advanced HCC than sorafenib monotherapy. The investigators propose to conduct a phase I study to determine maximal tolerated dose (MTD) of S-1 in combination with fixed dose of sorafenib in patients with advanced HCC
Timeline
- Start
- 2009-09
- Primary completion
- 2010-09
- Completion
- 2011-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | S-1 | Small molecule | — | — |
| Background | Sorafenib | Small molecule | 400 mg | — |