Intraoperative Chemotherapy Against Hepatocellular Carcinoma Recurrence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-12-31

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.

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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5-FU+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.

Group Type EXPERIMENTAL

sustained released 5-FU and sustained released cisplatin

Intervention Type DRUG

600mg sustained released 5-FU and 60mg sustained released cisplatin will be implanted into liver incisal margin after tumor is resected.

TACE

Intervention Type PROCEDURE

All patients will accept TACE one month after tumor was resected.

5-FU

50 HCC patients will be implanted 600mg sustained released 5-FU into liver incisal margin after tumor is resected.

Group Type ACTIVE_COMPARATOR

sustained released 5-FU

Intervention Type DRUG

600mg sustained released 5-FU will be implanted into liver incisal margin after tumor is resected.

TACE

Intervention Type PROCEDURE

All patients will accept TACE one month after tumor was resected.

control

Group Type EXPERIMENTAL

TACE

Intervention Type PROCEDURE

All patients will accept TACE one month after tumor was resected.

Interventions

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sustained released 5-FU and sustained released cisplatin

600mg sustained released 5-FU and 60mg sustained released cisplatin will be implanted into liver incisal margin after tumor is resected.

Intervention Type DRUG

sustained released 5-FU

600mg sustained released 5-FU will be implanted into liver incisal margin after tumor is resected.

Intervention Type DRUG

TACE

All patients will accept TACE one month after tumor was resected.

Intervention Type PROCEDURE

Other Intervention Names

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5-FU+Cisplatin group 5-FU group Postoperative TACE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No