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

Primary Purpose

Hepatocellular Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Hepatectomy
TACE
Sponsored by
Eastern Hepatobiliary Surgery Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Carcinoma, Hepatocellular, Hepatectomy, Transarterial Chemoembolization, Scoring System

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eastern hepatobilliary surgery hospitalRecruiting
  • Eastern hepatobilliary surgery hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Hepatectomy with NDR 0-2

TACE with NDR 0-2

Hepatectomy with NDR >2

TACE with NDR >2

Arm Description

Surgical removal of all lesions for patients with a NDR score 0-2 according to the NDR scoring system

Transarterial chemoembolization for patients with a NDR score 0-2 according to the NDR scoring system

Surgical removal of all lesions for patients with a NDR score more than 2 according to the NDR scoring system

Transarterial chemoembolization for patients with a NDR score more than 2 according to the NDR scoring system

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

Time to recurrence

Full Information

First Posted
August 10, 2015
Last Updated
March 30, 2016
Sponsor
Eastern Hepatobiliary Surgery Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02525952
Brief Title
Treatment for Patients With Multiple Hepatocellular Carcinomas Based on the NDR Scoring System
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Hepatobiliary Surgery Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Carcinoma, Hepatocellular, Hepatectomy, Transarterial Chemoembolization, Scoring System

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hepatectomy with NDR 0-2
Arm Type
Experimental
Arm Description
Surgical removal of all lesions for patients with a NDR score 0-2 according to the NDR scoring system
Arm Title
TACE with NDR 0-2
Arm Type
Active Comparator
Arm Description
Transarterial chemoembolization for patients with a NDR score 0-2 according to the NDR scoring system
Arm Title
Hepatectomy with NDR >2
Arm Type
Experimental
Arm Description
Surgical removal of all lesions for patients with a NDR score more than 2 according to the NDR scoring system
Arm Title
TACE with NDR >2
Arm Type
Active Comparator
Arm Description
Transarterial chemoembolization for patients with a NDR score more than 2 according to the NDR scoring system
Intervention Type
Procedure
Intervention Name(s)
Hepatectomy
Intervention Description
Surgical removal of all lesions
Intervention Type
Procedure
Intervention Name(s)
TACE
Intervention Description
Transarterial chemoembolization with lipiodol and pirarubicin
Primary Outcome Measure Information:
Title
overall survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Time to recurrence
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Preoperative ECOG criteria score of 0-1 Child-Pugh class A liver function Multiple hepatocellular carcinomas with tumor number <=5 and total tumor diameter <=15 cm Exclusion Criteria: Major portal/hepatic vein invasion Extrahepatic metastasis Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction,which may affect the treatment of liver cancer Anticancer treatment before surgery Lost to follow-up
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shen Feng, MD
Phone
0086-021-25070805
Email
shenfengdfgd@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shen Feng, MD
Organizational Affiliation
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Eastern hepatobilliary surgery hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200438
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Xia, Doctor
Phone
86-021-81875495
Facility Name
Eastern hepatobilliary surgery hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200438
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shen Feng, MD
Phone
0086-021-25070805
Email
shenfengdfgd@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Wu Dong, MD
Phone
0086-021-25070765
Email
wuyuz@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Shen Feng, MD

12. IPD Sharing Statement

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

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