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The Effect of Fluorouracil Implants Regional Chemotherapy During the Surgical Treatment for Early Stage Hepatocellular Carcinoma

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ClinicalTrials.gov Identifier: NCT01055743
Recruitment Status : Unknown
Verified January 2010 by Simcere Pharmaceutical Co., Ltd.
Recruitment status was:  Recruiting
First Posted : January 26, 2010
Last Update Posted : January 26, 2010
Sponsor:
Collaborator:
Information provided by:

January 22, 2010
January 26, 2010
January 26, 2010
August 2009
August 2014   (Final data collection date for primary outcome measure)
To assess the clinical benefit of fluorouracil implants regional chemotherapy during the radical resection in early stage hepatocellular carcinoma patients. The primary endpoint is disease-free survival (DFS). [ Time Frame: 1, 2, and 3 years ]
Same as current
No Changes Posted
  • Quality of Life [ Time Frame: from baseline to the last visit ]
  • Incidence Rate of Complications [ Time Frame: 1, 2, and 3 years ]
  • Adverse Events [ Time Frame: from the beginning of treatment to the end of study ]
Same as current
Not Provided
Not Provided
 
The Effect of Fluorouracil Implants Regional Chemotherapy During the Surgical Treatment for Early Stage Hepatocellular Carcinoma
A Randomized, Controlled Trial of Fluorouracil Implants Regional Chemotherapy During the Surgical Treatment for Early Stage Hepatocellular Carcinoma
This study will assess the clinical efficacy and safety of fluorouracil implants regional chemotherapy during the surgical treatment for early-stage hepatocellular carcinoma.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Early Stage Hepatocellular Carcinoma
  • Procedure: Radical resection
    Radical resection of hepatocellular carcinoma
  • Drug: Fluorouracil Implants
    Implanted during the surgical treatment
  • Experimental: Radical resection + Fluorouracil Implants
    Interventions:
    • Procedure: Radical resection
    • Drug: Fluorouracil Implants
  • Active Comparator: Radical resection
    Intervention: Procedure: Radical resection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
250
August 2014
August 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histological diagnosis of stage I hepatocellular carcinoma
  • Child-Pugh class A, B
  • Radical resection is feasible
  • Patients with adequate renal, hepatic, and hematologic function
  • Written informed consent

Exclusion Criteria:

  • Allergic to chemotherapy drugs
  • No measurable lesion
  • Receive chemotherapy, radiotherapy or biotherapy within 30 days prior to enrollment
  • Evidence of serious infection
  • Renal or hepatic dysfunction, significant cardiovascular disease
  • Pregnant or lactating women
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01055743
2009PHC001
Yes
Not Provided
Not Provided
Shuqun Cheng, Eastern Hepatobiliary Surgery Hospital
Simcere Pharmaceutical Co., Ltd
Eastern Hepatobiliary Surgery Hospital
Principal Investigator: Shuqun Cheng, MD Eastern Hepatobiliary Surgery Hospital
Simcere Pharmaceutical Co., Ltd
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP