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

Phase 2

• Conditions: Early Stage Hepatocellular Carcinoma
• Interventions: Procedure: Radical resection; Drug: Fluorouracil Implants

• Registration Number: NCT01055743
• Lead Sponsor: Simcere Pharmaceutical Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Status Verified: 2010-01
• Study First Submitted: 2010-01-22
• Study First Submitted QC: 2010-01-24
• Last Update Submitted: 2010-01-24
• Study First Posted: 2010-01-26
• Last Update Posted: 2010-01-26
• Primary Completion: 2014-08
• Study Completion: 2014-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radical resection + Fluorouracil Implants	Radical resection	-
Radical resection + Fluorouracil Implants	Fluorouracil Implants	-
Radical resection	Radical resection	-

Primary Outcome Measures

Name	Time	Method
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).	1, 2, and 3 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Eastern Hepatobiliary Surgery Hospital; 🇨🇳 Shanghai, China