Intraoperative Chemotherapy Against Hepatocellular Carcinoma Recurrence

Study Overview
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Brief Summary
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Hepatectomy is still the most important treatment for HCC.High recurrence rate mostly influence it's prognosis, especially for the patient with tumor >5cm, multiple tumor and who cannot accept R0 resection.Our retrospective study showed sustained released 5-FU implanted into the liver incisal margin after tumor was resected could reduce the recurrence rate of HCC after liver resection.According to this, we proceed this RCT to prospectively observe the effect of sustained released 5-FU,and we also want to know whether combined with sustained released cisplatin will get better effect in preventing the tumor recurrence,especially in short time after liver resection.

Detailed Description
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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.

Official Title
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Clinical Randomized Control Trial of Intraoperative Implanting Chemotherapeutic Drugs Sustained Release Following Resection of Hepatocellular Carcinoma Against Postoperative Short-term Recurrence

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: sustained released 5-FU and sustained released cisplatin
* Drug: sustained released 5-FU
* Procedure: TACE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: tumor >5cm; multiple tumor located in one liver lobe; margin of tumor is not clear; cutting edge to tumor <1cm; portal vein branch invasion; without extra-liver metastasis; patient's liver function and condition is able to accept hepatectomy. Exclusion Criteria: single tumor <=5cm; multiple tumor located more than in one liver lobe; margin of tumor is clear; cutting edge to tumor >=1cm; portal vein stem invasion extra-liver metastasis; patient's liver function and condition cannot accept hepatectomy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5-FU+Cisplatin<br>50 HCC patients will be implanted 600mg sustained released 5-FU and 60mg sustained released cisplatin into liver incisal margin after tumor is resected. | Drug: sustained released 5-FU and sustained released cisplatin<br>* 600mg sustained released 5-FU and 60mg sustained released cisplatin will be implanted into liver incisal margin after tumor is resected.<br>* Other names: 5-FU+Cisplatin group;Procedure: TACE<br>* All patients will accept TACE one month after tumor was resected.<br>* Other names: Postoperative TACE;|
| Active Comparator: 5-FU<br>50 HCC patients will be implanted 600mg sustained released 5-FU into liver incisal margin after tumor is resected. | Drug: sustained released 5-FU<br>* 600mg sustained released 5-FU will be implanted into liver incisal margin after tumor is resected.<br>* Other names: 5-FU group;Procedure: TACE<br>* All patients will accept TACE one month after tumor was resected.<br>* Other names: Postoperative TACE;|
| Experimental: control<br> | Procedure: TACE<br>* All patients will accept TACE one month after tumor was resected.<br>* Other names: Postoperative TACE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatocellular carcinoma, liver resection, intraoperative chemotherapy