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

NCT ID: NCT01055743

Last Updated: 2010-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2014-08-31

Brief Summary

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

Detailed Description

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Conditions

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Early Stage Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radical resection + Fluorouracil Implants

Group Type EXPERIMENTAL

Radical resection

Intervention Type PROCEDURE

Radical resection of hepatocellular carcinoma

Fluorouracil Implants

Intervention Type DRUG

Implanted during the surgical treatment

Radical resection

Group Type ACTIVE_COMPARATOR

Radical resection

Intervention Type PROCEDURE

Radical resection of hepatocellular carcinoma

Interventions

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Radical resection

Radical resection of hepatocellular carcinoma

Intervention Type PROCEDURE

Fluorouracil Implants

Implanted during the surgical treatment

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eastern Hepatobiliary Surgery Hospital

OTHER

Sponsor Role collaborator

Simcere Pharmaceutical Co., Ltd

OTHER

Sponsor Role lead

Responsible Party

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Eastern Hepatobiliary Surgery Hospital

Principal Investigators

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Shuqun Cheng, MD

Role: PRINCIPAL_INVESTIGATOR

Eastern Hepatobiliary Surgery Hospital

Locations

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Eastern Hepatobiliary Surgery Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shuqun Cheng, MD

Role: CONTACT

86-021-81875251

Facility Contacts

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Shuqun Cheng, MD

Role: primary

86-021-81875251

Other Identifiers

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2009PHC001

Identifier Type: -

Identifier Source: org_study_id

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