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

January 24, 2010 updated by: Simcere Pharmaceutical Co., Ltd

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200438
        • Recruiting
        • Eastern Hepatobiliary Surgery Hospital
        • Contact:
          • Shuqun Cheng, MD
          • Phone Number: 86-021-81875251
        • Principal Investigator:
          • Shuqun Cheng, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1, 2, and 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of Life
Time Frame: from baseline to the last visit
from baseline to the last visit
Incidence Rate of Complications
Time Frame: 1, 2, and 3 years
1, 2, and 3 years
Adverse Events
Time Frame: from the beginning of treatment to the end of study
from the beginning of treatment to the end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Simcere Pharmaceutical Co., Ltd

Collaborators

Eastern Hepatobiliary Surgery Hospital

Investigators

  • Principal Investigator: Shuqun Cheng, MD, Eastern Hepatobiliary Surgery Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Anticipated)

August 1, 2014

Study Completion (Anticipated)

August 1, 2014

Study Registration Dates

First Submitted

January 22, 2010

First Submitted That Met QC Criteria

January 24, 2010

First Posted (Estimate)

January 26, 2010

Study Record Updates

Last Update Posted (Estimate)

January 26, 2010

Last Update Submitted That Met QC Criteria

January 24, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009PHC001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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