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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2010 by Simcere Pharmaceutical Co., Ltd.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01055743
First Posted: January 26, 2010
Last Update Posted: January 26, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eastern Hepatobiliary Surgery Hospital
Information provided by:
Simcere Pharmaceutical Co., Ltd
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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 ]

Secondary Outcome Measures:
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Shuqun Cheng, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier: NCT01055743     History of Changes
Other Study ID Numbers: 2009PHC001
First Submitted: January 22, 2010
First Posted: January 26, 2010
Last Update Posted: January 26, 2010
Last Verified: January 2010

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
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs