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NCT01489566
A Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Phase III Clinical Trial to Evaluate the Safety and Efficacy of Injectable Tyroserleutide to Treat Hepatocellular Carcinoma
Phase 3 trial testing Tyroserleutide for injection ,chemotherapy(mitomycin, and Fluorouracil ) in Hepatocellular,Carcinoma in 300 participants. Status unknown.
1 March 2013
Quick facts
| Lead sponsor | Shenzhen Kangzhe Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 300 |
| Start date | 1 July 2011 |
| Primary completion | 1 March 2013 |
| Estimated completion | 1 August 2013 |
| Sites | 1 location across China |
Drugs / interventions tested
- Tyroserleutide for injection ,chemotherapy(mitomycin, and Fluorouracil ) — full drug profile →
- the placebo ,chemotherapy(mitomycin, and Fluorouracil ) — full drug profile →
Conditions studied
- Hepatocellular,Carcinoma — all drugs for Hepatocellular,Carcinoma →
Sponsor
Shenzhen Kangzhe Pharmaceutical Co., Ltd. — full company profile →
Who can join
Adults 18 to 75, any sex, with Hepatocellular,Carcinoma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
RFS(Recurrence Free Survival)
Time frame: 0-2years
The time from randomization to recurrence, metastasis or death due to any reason
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01489566
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01489566 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shenzhen Kangzhe Pharmaceutical Co., Ltd.
- Last refreshed: 13 December 2011
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01489566.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing