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

Early Stage Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01055743
• Other study ID #: 2009PHC001
• Status: Recruiting
• Phase: Phase 2
• First received: January 22, 2010
• Last updated: January 24, 2010
• Start date: August 2009
• Est. completion date: August 2014

Study information

• Verified date: January 2010
• Source: Simcere Pharmaceutical Co., Ltd
• Contact: Shuqun Cheng, MD
• Phone: 86-021-81875251
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Early Stage Hepatocellular Carcinoma

Intervention

Procedure:
• Radical resection
Radical resection of hepatocellular carcinoma

Drug:
• Fluorouracil Implants
Implanted during the surgical treatment

Locations

Country	Name	City	State
China	Eastern Hepatobiliary Surgery Hospital	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Simcere Pharmaceutical Co., Ltd	Eastern Hepatobiliary Surgery Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Quality of Life		from baseline to the last visit	No
Secondary	Incidence Rate of Complications		1, 2, and 3 years	Yes
Secondary	Adverse Events		from the beginning of treatment to the end of study	Yes