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

Primary Purpose

Early Stage Hepatocellular Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Radical resection
Fluorouracil Implants
Sponsored by
Simcere Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early Stage Hepatocellular Carcinoma focused on measuring Fluorouracil Implants, Hepatocellular carcinoma, Radical resection

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eastern Hepatobiliary Surgery HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Radical resection + Fluorouracil Implants

Radical resection

Arm Description

Outcomes

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).

Secondary Outcome Measures

Quality of Life
Incidence Rate of Complications
Adverse Events

Full Information

First Posted
January 22, 2010
Last Updated
January 24, 2010
Sponsor
Simcere Pharmaceutical Co., Ltd
Collaborators
Eastern Hepatobiliary Surgery Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01055743
Brief Title
The Effect of Fluorouracil Implants Regional Chemotherapy During the Surgical Treatment for Early Stage Hepatocellular Carcinoma
Official Title
A Randomized, Controlled Trial of Fluorouracil Implants Regional Chemotherapy During the Surgical Treatment for Early Stage Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
August 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Simcere Pharmaceutical Co., Ltd
Collaborators
Eastern Hepatobiliary Surgery Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Stage Hepatocellular Carcinoma
Keywords
Fluorouracil Implants, Hepatocellular carcinoma, Radical resection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radical resection + Fluorouracil Implants
Arm Type
Experimental
Arm Title
Radical resection
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Radical resection
Intervention Description
Radical resection of hepatocellular carcinoma
Intervention Type
Drug
Intervention Name(s)
Fluorouracil Implants
Intervention Description
Implanted during the surgical treatment
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Quality of Life
Time Frame
from baseline to the last visit
Title
Incidence Rate of Complications
Time Frame
1, 2, and 3 years
Title
Adverse Events
Time Frame
from the beginning of treatment to the end of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shuqun Cheng, MD
Phone
86-021-81875251
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuqun Cheng, MD
Organizational Affiliation
Eastern Hepatobiliary Surgery Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eastern Hepatobiliary Surgery Hospital
City
Shanghai
ZIP/Postal Code
200438
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuqun Cheng, MD
Phone
86-021-81875251
First Name & Middle Initial & Last Name & Degree
Shuqun Cheng, MD

12. IPD Sharing Statement

Learn more about this trial

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

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