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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
disease free survival
Shen Feng, MD.
Eastern Hepatobiliary Surgery Hospital
China: Ministry of Health