drugset / Trial / NCT01489566
Study of Tyroserleutide for Injection in Hepatocellular Carcinoma (HCC) Patients
Phase 3
Unknown
300 enrolled
Shenzhen Kangzhe Pharmaceutical Co., Ltd.
Fudan University · collabMedpace, Inc. · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a randomized, double-blinded, placebo-controlled, multi-center Clinical Trial. Patients with no tumor lesions one month after resection of hepatocellular carcinoma will be randomized in a 1:1 ratio to 1 of the 2 treatment groups:6mg/d Tyroserleutide (injection), or placebo. The objective is to evaluate the effect of Injectable Tyroserleutide on the recurrence-free survival,overall survival,quality of life,and the safety and tolerability of subjects after the resection of hepatocellular carcinoma
Timeline
- Start
- 2011-07
- Primary completion
- 2013-03
- Completion
- 2013-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Tyroserleutide | Unknown | 6 mg | — |
| Comparator | Mitomycin C | Other / unclassified | 10 mg | — |
| Comparator | fluorouracil | Small molecule | 1 g | — |