Trial Information
A Randomized, Controlled Trial of Fluorouracil Implants Regional Chemotherapy During the Surgical Treatment for Early Stage Hepatocellular Carcinoma
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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).
Outcome Time Frame:
1, 2, and 3 years
Safety Issue:
No
Principal Investigator
Shuqun Cheng, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Eastern Hepatobiliary Surgery Hospital
Authority:
China: Ethics Committee
Study ID:
2009PHC001
NCT ID:
NCT01055743
Start Date:
August 2009
Completion Date:
August 2014
Related Keywords:
- Early Stage Hepatocellular Carcinoma
- Fluorouracil Implants
- Hepatocellular carcinoma
- Radical resection
- Carcinoma
- Carcinoma, Hepatocellular