Intraoperative Chemotherapy Against Hepatocellular Carcinoma Recurrence

Not Applicable

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: sustained released 5-FU and sustained released cisplatin; Drug: sustained released 5-FU; Procedure: TACE

• Registration Number: NCT00817895
• Lead Sponsor: Eastern Hepatobiliary Surgery Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-01-04
• Study First Submitted QC: 2009-01-06
• Study First Posted: 2009-01-07
• Primary Completion: 2009-12
• Study Completion: 2010-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-29
• Last Update Posted: 2016-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5-FU+Cisplatin	sustained released 5-FU and sustained released cisplatin	50 HCC patients will be implanted 600mg sustained released 5-FU and 60mg sustained released cisplatin into liver incisal margin after tumor is resected.
5-FU+Cisplatin	TACE	50 HCC patients will be implanted 600mg sustained released 5-FU and 60mg sustained released cisplatin into liver incisal margin after tumor is resected.
5-FU	sustained released 5-FU	50 HCC patients will be implanted 600mg sustained released 5-FU into liver incisal margin after tumor is resected.
5-FU	TACE	50 HCC patients will be implanted 600mg sustained released 5-FU into liver incisal margin after tumor is resected.
control	TACE	-

Primary Outcome Measures

Name	Time	Method
disease free survival	2 years

Secondary Outcome Measures

Name	Time	Method
overall survival	2 years

Trial Locations

Locations (1)

Eastern Hepatobiliary Surgery Hospital; 🇨🇳 Shanghai, Shanghai, China