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
- 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
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