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

Naval Military Medical University (Second Military Medical University)

Status: Unknown

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: TACE; Procedure: Hepatectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02525952

EHBHKY2015-01-012

Details and patient eligibility

About

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

Full 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.

Enrollment: 320 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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320 participants in 4 patient groups

Hepatectomy with NDR 0-2

Experimental group

Description:

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

Treatment:

Procedure: Hepatectomy

TACE with NDR 0-2

Active Comparator group

Description:

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

Treatment:

Procedure: TACE

Hepatectomy with NDR >2

Experimental group

Description:

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

Treatment:

Procedure: Hepatectomy

TACE with NDR >2

Active Comparator group

Description:

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

Treatment:

Procedure: TACE