Early Stage Hepatocellular Carcinoma
Conditions
Keywords
Fluorouracil Implants, Hepatocellular carcinoma, Radical resection
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.
Interventions
PROCEDURERadical resection
Radical resection of hepatocellular carcinoma
Implanted during the surgical treatment
Sponsors
Eastern Hepatobiliary Surgery Hospital
Simcere Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Contacts
Primary ContactShuqun Cheng, MD
Outcome results
None listed