A Randomized, Controlled Trial of Fluorouracil Implants Regional Chemotherapy During the Surgical Treatment for Early Stage Hepatocellular Carcinoma

Simcere Pharmaceutical Co., Ltd1 site in 1 country250 target enrollmentAugust 2009

ConditionsEarly Stage Hepatocellular Carcinoma

InterventionsRadical resection Fluorouracil Implants

DrugsFluorouracil Implants

Overview

Phase: Phase 2
Intervention: Radical resection
Conditions: Early Stage Hepatocellular Carcinoma
Sponsor: Simcere Pharmaceutical Co., Ltd
Enrollment: 250
Locations: 1
Primary Endpoint: 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).
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2009

End Date

August 2014

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Simcere Pharmaceutical Co., Ltd

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

Arms & Interventions

Radical resection

Intervention: Radical resection

Radical resection + Fluorouracil Implants

Intervention: Radical resection

Radical resection + Fluorouracil Implants

Intervention: Fluorouracil Implants

Outcomes

Primary Outcomes

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