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NCT00644020
A Randomized, Double Blind, Placebo Controled, Multicenter Phase ⅡStudy to Evaluate the Safety and Efficacy of Tyroserleutide for Injection in Hepatocellular Carcinoma(HCC) Patients
trial testing mitomycin, Fluorouracil in Hepatocellular Carcinoma in 100 participants. Status unknown.
1 August 2008
Quick facts
| Lead sponsor | Shenzhen Kangzhe Pharmaceutical Co., Ltd. |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 100 |
| Start date | 1 December 2007 |
| Primary completion | 1 August 2008 |
| Estimated completion | 1 August 2008 |
| Sites | 1 location across China |
Drugs / interventions tested
- mitomycin, 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.
-
DFS(disease free survival)
Time frame: six month
Sponsor's own description
The investigation is a randomized, double-blind, placebo involved and multi-center clinical trial. All subjects are assigned to 4 groups, including 3mg, 6mg, 12mg per day and placebo group. Each group includes 25 subjects, who have hepatic-cellular carcinoma accompanied with branch vein thrombosis. They receive investigational drug 40 days after resection surgery. Each cycle lasts 4 to 6 days with an interval of 29 days in all 6 cycles.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT00644020
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Shenzhen Kangzhe Pharmaceutical Co., Ltd. trials
Trials by the same sponsor.
- NCT05439577 — A Multicentre Study to Explore the Efficacy and Safety of Mucopolysaccharide Polysulfate Cream in Patients With Eczema · unknown
- NCT05273944 — Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection (Lipodox®) in Chinese Patients · Phase 1 · unknown
- NCT05108766 — A Phase Ⅲ Study to Evaluate Tildrakizumab in the Treatment of Chinese Subjects With Moderate to Severe Plaquetype Psoria · Phase 3 · completed
- NCT04057326 — A Study of Oryz-Aspergillus Enzyme and Pancreatin Tablet in Patients With Cirrhosis and Malnutrition · NA · unknown
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 NCT00644020 (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: 25 March 2008
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/NCT00644020.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing