Back to resultsPostoperative TACE(Transhepatic Arterial Chemotherapy And Embolization) for Patients With Hepatocellular Carcinoma
Primary Purpose
Hepatocellular Carcinoma, Transcatheter Arterial Chemoembolization
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transcatheter Arterial Chemoembolization
No intervention No Transcatheter Arterial Chemoembolization
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring TACE, Postoperation
Eligibility Criteria
Inclusion Criteria:
- Pathological diagnosis of HCC (AJCC stage I or II)
- Without recurrence in 1 month postoperation
- Must be tolerant to TACE
Exclusion Criteria:
- With intrahepatic recurrence postoperation
- Insufficient liver function
- Stage III or IV
Sites / Locations
- The Second Affiliated Hospital, Zhejiang University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TACE
Control
Arm Description
Patients after surgery receive Transcatheter Arterial Chemoembolization (TACE)
Patients after surgery do not receive TACE
Outcomes
Primary Outcome Measures
DFS(Disease free survival)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02109146
Brief Title
Postoperative TACE(Transhepatic Arterial Chemotherapy And Embolization) for Patients With Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2014 (undefined)
Primary Completion Date
July 30, 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University
4. Oversight
5. Study Description
Brief Summary
Hepatocellular carcinoma (HCC) is the most common primary malignancy of liver, representing the third leading cause of cancer-related death worldwide.
Its overall dismal prognosis is a result of high incidence rates of metastasis and postoperative recurrence, in particular the intrahepatic recurrence.
TACE is the most widely used primary treatment for unresectable HCC. It was also used as the optional treatment of relapsed disease. However, the efficacy of TACE used as adjuvant therapy following hepatectomy remains controversial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Transcatheter Arterial Chemoembolization
Keywords
TACE, Postoperation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TACE
Arm Type
Experimental
Arm Description
Patients after surgery receive Transcatheter Arterial Chemoembolization (TACE)
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients after surgery do not receive TACE
Intervention Type
Drug
Intervention Name(s)
Transcatheter Arterial Chemoembolization
Intervention Description
Transcatheter Arterial Chemoembolization should be used in the experimental group
Intervention Type
Other
Intervention Name(s)
No intervention No Transcatheter Arterial Chemoembolization
Primary Outcome Measure Information:
Title
DFS(Disease free survival)
Time Frame
Time point at when patient was diagnosed recurrence,an expected average of 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pathological diagnosis of HCC (AJCC stage I or II)
Without recurrence in 1 month postoperation
Must be tolerant to TACE
Exclusion Criteria:
With intrahepatic recurrence postoperation
Insufficient liver function
Stage III or IV
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tingbo Liang, M.D Ph.D
Phone
+86-0577-87783510
Email
liangtingbo@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tingbo Liang, M.D Ph.D
Organizational Affiliation
Zhejiang University
Official's Role
Study Chair
Facility Information:
Facility Name
The Second Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tingbo Liang
Email
liangtingbo@zju.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Postoperative TACE(Transhepatic Arterial Chemotherapy And Embolization) for Patients With Hepatocellular Carcinoma
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