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

NCT ID: NCT02525952

Last Updated: 2016-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Hepatocellular Carcinoma

Keywords

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Carcinoma, Hepatocellular Hepatectomy Transarterial Chemoembolization Scoring System

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Hepatectomy with NDR 0-2

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

Group Type EXPERIMENTAL

Hepatectomy

Intervention Type PROCEDURE

Surgical removal of all lesions

TACE with NDR 0-2

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

Group Type ACTIVE_COMPARATOR

TACE

Intervention Type PROCEDURE

Transarterial chemoembolization with lipiodol and pirarubicin

Hepatectomy with NDR >2

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

Group Type EXPERIMENTAL

Hepatectomy

Intervention Type PROCEDURE

Surgical removal of all lesions

TACE with NDR >2

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

Group Type ACTIVE_COMPARATOR

TACE

Intervention Type PROCEDURE

Transarterial chemoembolization with lipiodol and pirarubicin

Interventions

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Hepatectomy

Surgical removal of all lesions

Intervention Type PROCEDURE

TACE

Transarterial chemoembolization with lipiodol and pirarubicin

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eastern Hepatobiliary Surgery Hospital

OTHER

Sponsor Role lead

Responsible Party

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ShenFeng

vice president of the Eastern Hepatobiliary Surgery Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shen Feng, MD

Role: STUDY_CHAIR

Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

Locations

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Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shen Feng, MD

Role: CONTACT

Phone: 0086-021-25070805

Email: [email protected]

Facility Contacts

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Yong Xia, Doctor

Role: primary

Shen Feng, MD

Role: primary

Wu Dong, MD

Role: backup

Other Identifiers

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EHBHKY2015-01-012

Identifier Type: -

Identifier Source: org_study_id