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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
Eastern Hepatobiliary Surgery Hospital
Information provided by:
Simcere Pharmaceutical Co., Ltd Identifier:
First received: January 22, 2010
Last updated: January 24, 2010
Last verified: January 2010
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:

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


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01055743

Eastern Hepatobiliary Surgery Hospital
Shanghai, China, 200438
Sponsors and Collaborators
Simcere Pharmaceutical Co., Ltd
Eastern Hepatobiliary Surgery Hospital
Principal Investigator: Shuqun Cheng, MD Eastern Hepatobiliary Surgery Hospital
  More Information

Responsible Party: Shuqun Cheng, Eastern Hepatobiliary Surgery Hospital 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, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on January 14, 2017