Treatment for Patients With Multiple Hepatocellular Carcinomas Based on the NDR Scoring System
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
1 other identifier
interventional
320
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hepatocellular-carcinoma
Started Oct 2015
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2015
CompletedFirst Posted
Study publicly available on registry
August 18, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMarch 31, 2016
March 1, 2016
2.2 years
August 10, 2015
March 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall survival
5 years
Secondary Outcomes (1)
Time to recurrence
5 years
Study Arms (4)
Hepatectomy with NDR 0-2
EXPERIMENTALSurgical removal of all lesions for patients with a NDR score 0-2 according to the NDR scoring system
TACE with NDR 0-2
ACTIVE COMPARATORTransarterial chemoembolization for patients with a NDR score 0-2 according to the NDR scoring system
Hepatectomy with NDR >2
EXPERIMENTALSurgical removal of all lesions for patients with a NDR score more than 2 according to the NDR scoring system
TACE with NDR >2
ACTIVE COMPARATORTransarterial chemoembolization for patients with a NDR score more than 2 according to the NDR scoring system
Interventions
Transarterial chemoembolization with lipiodol and pirarubicin
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Eastern hepatobilliary surgery hospital
Shanghai, Shanghai Municipality, 200438, China
Eastern hepatobilliary surgery hospital
Shanghai, Shanghai Municipality, 200438, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Shen Feng, MD
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- vice president of the Eastern Hepatobiliary Surgery Hospital
Study Record Dates
First Submitted
August 10, 2015
First Posted
August 18, 2015
Study Start
October 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
March 31, 2016
Record last verified: 2016-03