Clinical Randomized Control Trial of Intraoperative Implanting Chemotherapeutic Drugs Sustained Release Following Resection of Hepatocellular Carcinoma Against Postoperative Short-Term Recurrence
18 Years
75 Years
Both
Hepatocellular Carcinoma
Trial Information
Clinical Randomized Control Trial of Intraoperative Implanting Chemotherapeutic Drugs Sustained Release Following Resection of Hepatocellular Carcinoma Against Postoperative Short-Term Recurrence
150 HCC patients with tumor >5cm, multiple tumor and who cannot accept R0 resection will be
randomized divided into 3 groups. Group A (50 cases) will be implanted 600mg sustained
released 5-FU into liver incisal margin after tumor is resected. Group B (50 cases) will be
implanted 600mg sustained released 5-FU and 60mg sustained released cisplatin. Group C (50
cases) will be the controlled one which will not be implanted any chemotherapeutic drugs.
All patients will accepted TACE 30 days after liver resection. We will follow up all
patients until they are dead or missed connected. Related adverse reaction will be recorded.
Total survival time (TST) and disease free survival time (DFST) will be calculated too. At
the end of the study we will compare the difference of adverse reaction, complication, TST
and DFST between the 3 groups. According to the result we will estimate these drugs'
antitumor effect and safety.
Inclusion Criteria:
1. tumor >5cm;
2. multiple tumor located in one liver lobe;
3. margin of tumor is not clear;
4. cutting edge to tumor <1cm;
5. portal vein branch invasion;
6. without extra-liver metastasis;
7. patient's liver function and condition is able to accept hepatectomy.
Exclusion Criteria:
1. single tumor <=5cm;
2. multiple tumor located more than in one liver lobe;
3. margin of tumor is clear;
4. cutting edge to tumor >=1cm;
5. portal vein stem invasion
6. extra-liver metastasis;
7. patient's liver function and condition cannot accept hepatectomy.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
disease free survival
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Shen Feng, MD.
Investigator Role:
Study Chair
Investigator Affiliation:
Eastern Hepatobiliary Surgery Hospital
Authority:
China: Ministry of Health
Study ID:
EHBH-RCT-2008-010
NCT ID:
NCT00817895
Start Date:
December 2008
Completion Date:
December 2010
Related Keywords:
- Hepatocellular Carcinoma
- hepatocellular carcinoma
- liver resection
- intraoperative chemotherapy
- Carcinoma
- Recurrence
- Carcinoma, Hepatocellular
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