Back to resultsTACE Plus Tegafur Versus TACE for Intrahepatic Cholangiocarcinoma After Curative Resection
Primary Purpose
Intrahepatic Cholangiocarcinoma
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
TACE+Tegafur
TACE
Sponsored by
About this trial
This is an interventional treatment trial for Intrahepatic Cholangiocarcinoma focused on measuring Chemoembolization, Therapeutic, Tegafur
Eligibility Criteria
Inclusion Criteria:
- Male or female patients > 18 years and <=70 years of age.
- Pathological evidence of ICC
- Tumors can be completely resected.
- Criteria of liver function: Child A-B level, serum bilirubin ≤ 1.5 times the upper limit of normal value, alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.
- Patients who can understand this trial and have signed information consent.
Exclusion Criteria:
- Tumors can not be resected .
- Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction, which may affect the treatment of Intrahepatic cholangiocarcinoma.
- Patients with a medical history of other malignant tumors.
- Subjects participating in other clinical trials.
- Liver function:Child C.
Sites / Locations
- Eastern hepatobilliary surgery hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
TACE+ Tegafur
TACE
Arm Description
Patients will be treated with Tegafur after resection soon, and TACE in 4 or 8 weeks after resection.
Patients will be treated with TACE alone in 4 or 8 weeks after resection.
Outcomes
Primary Outcome Measures
Overall survival rates of each group
Secondary Outcome Measures
Occurrence rate of recurrence of each group
Full Information
NCT ID
NCT02588755
First Posted
October 27, 2015
Last Updated
March 30, 2016
Sponsor
Eastern Hepatobiliary Surgery Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02588755
Brief Title
TACE Plus Tegafur Versus TACE for Intrahepatic Cholangiocarcinoma After Curative Resection
Official Title
Anti-tumor Recurrence With Transarterial Chemoembolization (TACE) Plus Tegafur Versus TACE on Patients With Intrahepatic Cholangiocarcinoma After Curative Resection：A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 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 compare the outcomes of Transarterial Chemoembolization (TACE) plus Tegafur with TACE alone in patients with intrahepatic cholangiocarcinoma after curative resection
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrahepatic Cholangiocarcinoma
Keywords
Chemoembolization, Therapeutic, Tegafur
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TACE+ Tegafur
Arm Type
Active Comparator
Arm Description
Patients will be treated with Tegafur after resection soon, and TACE in 4 or 8 weeks after resection.
Arm Title
TACE
Arm Type
Experimental
Arm Description
Patients will be treated with TACE alone in 4 or 8 weeks after resection.
Intervention Type
Procedure
Intervention Name(s)
TACE+Tegafur
Other Intervention Name(s)
TACE followed by Tegafur
Intervention Description
Tegafur: 40mg bid for 3 continuous months in 4 months. TACE: 4 or 8 weeks after resection.
Intervention Type
Procedure
Intervention Name(s)
TACE
Intervention Description
TACE alone
Primary Outcome Measure Information:
Title
Overall survival rates of each group
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Occurrence rate of recurrence of each group
Time Frame
3 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.
Pathological evidence of ICC
Tumors can be completely resected.
Criteria of liver function: Child A-B level, serum bilirubin ≤ 1.5 times the upper limit of normal value, alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.
Patients who can understand this trial and have signed information consent.
Exclusion Criteria:
Tumors can not be resected .
Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction, which may affect the treatment of Intrahepatic cholangiocarcinoma.
Patients with a medical history of other malignant tumors.
Subjects participating in other clinical trials.
Liver function:Child C.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wang Kui, MD
Phone
+86-021-81875242
Email
wangkuiykl@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shen Feng, MD
Phone
0086-021-25070805
Email
shenfengdfgd@yahoo.com.cn
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
Shen Feng, MD
Phone
0086-021-25070805
Email
shenfengdfgd@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Yong Xia, Doctor
Phone
86-021-81875495
First Name & Middle Initial & Last Name & Degree
Shen Feng, MD
12. IPD Sharing Statement
Learn more about this trial
TACE Plus Tegafur Versus TACE for Intrahepatic Cholangiocarcinoma After Curative Resection
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