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

This study is currently recruiting participants.
Verified January 2010 by Simcere Pharmaceutical Co., Ltd
Sponsor:
Collaborator:
Eastern Hepatobiliary Surgery Hospital
Information provided by:
Simcere Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01055743
First received: January 22, 2010
Last updated: January 24, 2010
Last verified: January 2010
History of Changes

January 22, 2010
January 24, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01055743 on ClinicalTrials.gov Archive Site
  • Quality of Life [ Time Frame: from baseline to the last visit ] [ Designated as safety issue: No ]
  • Incidence Rate of Complications [ Time Frame: 1, 2, and 3 years ] [ Designated as safety issue: Yes ]
  • Adverse Events [ Time Frame: from the beginning of treatment to the end of study ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
 
Recruiting
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
Both
18 Years to 75 Years
No
Contact: Shuqun Cheng, MD 86-021-81875251
China
 
NCT01055743
2009PHC001
Yes
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