Intraoperative Chemotherapy Against Hepatocellular Carcinoma Recurrence

NCT00817895 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2016-03-31

No results posted yet for this study

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.

Conditions

Interventions

DRUG

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.

DRUG

sustained released 5-FU

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

PROCEDURE

TACE

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

Sponsors & Collaborators

  • Eastern Hepatobiliary Surgery Hospital

    lead OTHER

Principal Investigators

  • Shen Feng, MD. · Eastern Hepatobiliary Surgery Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-12-31
Completion
2010-12-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00817895 on ClinicalTrials.gov