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

NCT ID: NCT02523053

Last Updated: 2016-10-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2018-12-31

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.

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.

Conditions

Hepatocellular Carcinoma; Recurrence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Hepatectomy

Surgical removal of all lesions

Group Type: ACTIVE_COMPARATOR

Hepatectomy

Intervention Type: PROCEDURE

Surgical removal of all lesions

Hepatectomy plus 5-Fluorouracil

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

Group Type: EXPERIMENTAL

Hepatectomy

Intervention Type: PROCEDURE

Surgical removal of all lesions

5-Fluorouracil

Intervention Type: DRUG

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

Interventions

Hepatectomy

Surgical removal of all lesions

Intervention Type: PROCEDURE

5-Fluorouracil

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eastern Hepatobiliary Surgery Hospital

OTHER

Sponsor Role: lead

Responsible Party

ShenFeng

Vice president of the Eastern Hepatobiliary Surgery Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shen Feng, MD

Role: STUDY_CHAIR

Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

Locations

Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Shen Feng, MD

Role: CONTACT

shenfengdfgd@yahoo.com.cn

0086-021-25070805

Other Identifiers

EHBHKY2015-01-011

Identifier Type: -

Identifier Source: org_study_id