NCT00817895

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Dec 2008

Shorter than P25 for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 7, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 31, 2016

Status Verified

March 1, 2016

Enrollment Period

1 year

First QC Date

January 4, 2009

Last Update Submit

March 29, 2016

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinomaliver resectionintraoperative chemotherapy

Outcome Measures

Primary Outcomes (1)

  • disease free survival

    2 years

Secondary Outcomes (1)

  • overall survival

    2 years

Study Arms (3)

5-FU+Cisplatin

EXPERIMENTAL

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 cisplatinProcedure: TACE

5-FU

ACTIVE COMPARATOR

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

Drug: sustained released 5-FUProcedure: TACE

control

EXPERIMENTAL
Procedure: TACE

Interventions

sustained released 5-FU and sustained released cisplatinDRUG

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

Also known as: 5-FU+Cisplatin group
5-FU+Cisplatin
sustained released 5-FUDRUG

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

Also known as: 5-FU group
5-FU
TACEPROCEDURE

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

Also known as: Postoperative TACE
5-FU5-FU+Cisplatincontrol

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, 200438, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Shen Feng, MD.

    Eastern Hepatobiliary Surgery Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vice president of the Eastern Hepatobiliary Surgery Hospotal

Study Record Dates

First Submitted

January 4, 2009

First Posted

January 7, 2009

Study Start

December 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2010

Last Updated

March 31, 2016

Record last verified: 2016-03

Locations

CN(1)