Treatment for Patients With Multiple Hepatocellular Carcinomas Based on the NDR Scoring System

March 30, 2016 updated by: ShenFeng, Eastern Hepatobiliary Surgery Hospital

A Randomized Controlled Trial to Compare the Outcomes Between Hepatectomy and Transarterial Chemoembolization for Patients With Multiple Hepatocellular Carcinomas Based on the NDR Scoring System

The aim of this study is to establish a selection criteria of hepatectomy for patients with multiple hepatocellular carcinomas based on the NDR Scoring System

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Multiple hepatocellular carcinomas (HCCs) accounts for 60% to 70% of patients with hepatocellular carcinoma.However,the selection criteria of hepatectomy for patients with multiple HCCs remains controversial.Researches have suggested that part of the patients with multiple HCCs can also benefit from hepatectomy.But,expanding the selection criteria for hepatectomy will increase tumor recurrence rates and reduce the therapeutic effect, more stringent selection criteria will also make part of the patients who should take hepatectomy lose the operation chance. This is a difficult problem in the research of this field.The Barcelona Clinic Liver Cancer (BCLC) system recommends that stage A (number ≤ 3, largest diameter ≤ 3 cm) were suitable for liver resection.However, increasing reports on good outcome after hepatectomy for patients with multiple HCCs have been published.Studies on clonal origin suggest that hepatectomy is a better treatment for multiple HCCs from multicentric origin (MO) than that from intrahepatic metastasis (IM) and the 5-year overall survival rates is 24% to 58%.The investigators established a scoring system(NDR score; N, tumor number; D, total tumor diameter; R, ratio of largest/smallest diameter) based on preoperative data which can accurately predict postoperative long-term survival of patients with multiple HCCs.The formula is as follows: 1×N（N: >3=1; ≤3= 0）+ 2×D（D: >8cm = 1; ≤8cm= 0）+ 1×R（R: >6 = 1; ≤6= 0）.The investigators first propose a selection criteria of hepatectomy for patients with multiple HCCs based on this scoring system. Patients with a NDR score 0-2 are recommended for hepatectomy and can benefit from the surgery,and because of the unsatisfied outcome,patients with a NDR score more than 2 are not recommended for hepatectomy.The stringent selection criteria should be expanded so that more patients can benefit from hepatectomy,and the less stringent criteria should be limited to ensure curative effect.So,the investigators' NDR scoring system was more accurate in selecting patients with multiple HCCs for hepatectomy and this article was published on Ann Surg Oncol（2015，22:826）.In order to further confirm the rationality of this selection criteria,the investigators would like to propose a prospective randomized controlled study.

Study Type

Interventional

Enrollment (Anticipated)

320

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
        • Recruiting
        • Eastern hepatobilliary surgery hospital
        • Contact:

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. Preoperative ECOG criteria score of 0-1
  4. Child-Pugh class A liver function
  5. Multiple hepatocellular carcinomas with tumor number <=5 and total tumor diameter <=15 cm

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. Anticancer treatment before surgery
  5. Lost to follow-up

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
Experimental: Hepatectomy with NDR 0-2
Surgical removal of all lesions for patients with a NDR score 0-2 according to the NDR scoring system
Procedure: Hepatectomy
Surgical removal of all lesions
Active Comparator: TACE with NDR 0-2
Transarterial chemoembolization for patients with a NDR score 0-2 according to the NDR scoring system
Procedure: TACE
Transarterial chemoembolization with lipiodol and pirarubicin
Experimental: Hepatectomy with NDR >2
Surgical removal of all lesions for patients with a NDR score more than 2 according to the NDR scoring system
Procedure: Hepatectomy
Surgical removal of all lesions
Active Comparator: TACE with NDR >2
Transarterial chemoembolization for patients with a NDR score more than 2 according to the NDR scoring system
Procedure: TACE
Transarterial chemoembolization with lipiodol and pirarubicin

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to recurrence
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

October 1, 2015

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

August 10, 2015

First Submitted That Met QC Criteria

August 14, 2015

First Posted (Estimate)

August 18, 2015

Study Record Updates

Last Update Posted (Estimate)

March 31, 2016

Last Update Submitted That Met QC Criteria

March 30, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EHBHKY2015-01-012

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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