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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
  Purpose

This study will assess the clinical efficacy and safety of fluorouracil implants regional chemotherapy during the surgical treatment for early-stage hepatocellular carcinoma.


Condition Intervention Phase
Early Stage Hepatocellular Carcinoma
 Procedure: Radical resection
Drug: Fluorouracil Implants
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Trial of Fluorouracil Implants Regional Chemotherapy During the Surgical Treatment for Early Stage Hepatocellular Carcinoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Simcere Pharmaceutical Co., Ltd:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 250
Study Start Date: August 2009
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radical resection + Fluorouracil Implants Procedure: Radical resection
Radical resection of hepatocellular carcinoma
Drug: Fluorouracil Implants
Implanted during the surgical treatment
Active Comparator: Radical resection Procedure: Radical resection
Radical resection of hepatocellular carcinoma

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01055743

Contacts
Contact: Shuqun Cheng, MD 86-021-81875251

Locations
China
Eastern Hepatobiliary Surgery Hospital Recruiting
Shanghai, China, 200438
Contact: Shuqun Cheng, MD     86-021-81875251        
Principal Investigator: Shuqun Cheng, MD            
Sponsors and Collaborators
Simcere Pharmaceutical Co., Ltd
Eastern Hepatobiliary Surgery Hospital
Investigators
Principal Investigator: Shuqun Cheng, MD Eastern Hepatobiliary Surgery Hospital
  More Information

No publications provided

Responsible Party: Shuqun Cheng, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier: NCT01055743     History of Changes
Other Study ID Numbers: 2009PHC001
Study First Received: January 22, 2010
Last Updated: January 24, 2010
Health Authority: China: Ethics Committee

Keywords provided by Simcere Pharmaceutical Co., Ltd:
Fluorouracil Implants
Hepatocellular carcinoma
Radical resection

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
 Fluorouracil
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013