Effect of Intraoperative Controlled Release 5-Fluorouracil Therapy on Recurrence in Hepatocellular Carcinoma Patients

October 20, 2016 updated by: ShenFeng, Eastern Hepatobiliary Surgery Hospital

A Randomized Controlled Study on the Effect of Intraoperative Controlled Release 5-Fluorouracil Therapy on Anti-tumor Recurrence in Hepatocellular Carcinoma Patients With High Risk of Microvascular Invasion Presence

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Surgical resection is the major curative treatment for patients with hepatocellular carcinoma (HCC). However, the postoperative 5-year recurrence rate after surgical resection was significantly high, which has been reported to 40%-70%.

Recurrence after surgery is the main factor affecting the efficacy of management of hepatocellular carcinoma, however, there are few methods for the prevention of recurrence and no standard treatment for recurrent HCC following curative-intent initial surgery has been established so far. The effective prevention of recurrence is the key to improve the management of HCC.

Previous studies showed the prevalence of microvascular invasion (MVI) in one of the critical and negative prognostic factors for HCC patients after partial hepatectomy or liver transplantation. For the early stage HCC patients, preoperative prediction of MVI is helpful to identify the appropriate object of anti-recurrence treatment before or after operation.

Our another previous study established a nomogram for MVI prediction of early HCC patients, which can preoperative efficiently predict the occurrence of MVI within Milan criteria, has been published online in JAMA surgery. On the other hand, there are only few studies reported the use of controlled release 5-Fluorouracil in the treatment of digestive tract tumors.

The action time of the controlled release 5-Fluorouracil particles is more than 15 days, the diffusion radius is 4-6cm. In theory, during the operation, the drug can be given to any location that may have tumor residues, timely and conveniently, and has a long time to maintain a high drug concentration, which is conducive to kill small metastatic foci caused by MVI. However, to our best knowledge, there is no evidence of high levels of evidence-based medical evidence to confirm the value of controlled release 5-Fluorouracil in the prevention of HCC recurrence.

In view of this, we aim to implement a randomized controlled study 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.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200438
        • Eastern hepatobilliary surgery hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hepatectomy
Surgical removal of all lesions
Procedure: Hepatectomy
Surgical removal of all lesions
Experimental: Hepatectomy plus 5-Fluorouracil
Surgical removal of all lesions and intraoperative controlled release 5-Fluorouracil therapy
Procedure: Hepatectomy
Surgical removal of all lesions
Drug: 5-Fluorouracil
Surgical removal of all lesions and intraoperative controlled release 5-Fluorouracil therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to tumor recurrence
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Hepatobiliary Surgery Hospital

Investigators

  • Study Chair: Shen Feng, MD, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

August 10, 2015

First Submitted That Met QC Criteria

August 12, 2015

First Posted (Estimate)

August 14, 2015

Study Record Updates

Last Update Posted (Estimate)

October 21, 2016

Last Update Submitted That Met QC Criteria

October 20, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EHBHKY2015-01-011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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