NCT02523053

Brief Summary

The aim of this study is to confirmed the role of intraoperative controlled release 5-Fluorouracil therapy in the prevention of recurrence after surgery for HCC patients with high risk of preoperative prediction of microvascular invasion.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 10, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 21, 2016

Status Verified

March 1, 2016

Enrollment Period

2.7 years

First QC Date

August 10, 2015

Last Update Submit

October 20, 2016

Conditions

Hepatocellular CarcinomaRecurrence

Keywords

Hepatocellular CarcinomaRecurrenceMicrovascular Invasion5-Fluorouracil

Outcome Measures

Primary Outcomes (1)

  • Time to tumor recurrence

    5 years

Secondary Outcomes (1)

  • Overall survival

    5 years

Study Arms (2)

Hepatectomy

ACTIVE COMPARATOR

Surgical removal of all lesions

Procedure: Hepatectomy

Hepatectomy plus 5-Fluorouracil

EXPERIMENTAL

Surgical removal of all lesions and intraoperative controlled release 5-Fluorouracil therapy

Procedure: HepatectomyDrug: 5-Fluorouracil

Interventions

HepatectomyPROCEDURE

Surgical removal of all lesions

HepatectomyHepatectomy plus 5-Fluorouracil
5-FluorouracilDRUG

Surgical removal of all lesions and intraoperative controlled release 5-Fluorouracil therapy

Hepatectomy plus 5-Fluorouracil

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients \> 18 years and \<=70 years of age
  • Patients preoperatively diagnosed of hepatocellular carcinoma according to the criteria of American Association for the Study of Liver Diseases(AASLD)
  • Within Milan criteria
  • Nomogram score for MVI prediction \>200
  • Preoperative ECOG criteria score of 0-1
  • Child-Pugh class A liver function
  • No Anticancer treatment before surgery

You may not qualify if:

  • Major portal/hepatic vein invasion
  • Extrahepatic metastasis
  • Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction,which may affect the treatment of liver cancer
  • Lost to follow-up
  • Patients participating in other clinical trials
  • Patients refused to join our trial
  • Pregnant and breast-feeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, 200438, China

Location

MeSH Terms

Conditions

Carcinoma, HepatocellularRecurrence

Interventions

HepatectomyFluorouracil

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, OperativeUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Shen Feng, MD

    Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

    STUDY CHAIR

Central Study Contacts

Shen Feng, MD

CONTACT

0086-021-25070805shenfengdfgd@yahoo.com.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president of the Eastern Hepatobiliary Surgery Hospital

Study Record Dates

First Submitted

August 10, 2015

First Posted

August 14, 2015

Study Start

April 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

October 21, 2016

Record last verified: 2016-03

Locations

CN(1)