TACE Plus Tegafur Versus TACE for Intrahepatic Cholangiocarcinoma After Curative Resection
Anti-tumor Recurrence With Transarterial Chemoembolization (TACE) Plus Tegafur Versus TACE on Patients With Intrahepatic Cholangiocarcinoma After Curative Resection：A Randomized Controlled Study
1 other identifier
interventional
180
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2015
CompletedFirst Posted
Study publicly available on registry
October 28, 2015
CompletedStudy Start
First participant enrolled
December 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 years
October 27, 2015
March 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival rates of each group
3 years
Secondary Outcomes (1)
Occurrence rate of recurrence of each group
3 years
Study Arms (2)
TACE+ Tegafur
ACTIVE COMPARATORPatients will be treated with Tegafur after resection soon, and TACE in 4 or 8 weeks after resection.
TACE
EXPERIMENTALPatients will be treated with TACE alone in 4 or 8 weeks after resection.
Interventions
Tegafur: 40mg bid for 3 continuous months in 4 months. TACE: 4 or 8 weeks after resection.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eastern hepatobilliary surgery hospital
Shanghai, Shanghai Municipality, 200438, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
October 27, 2015
First Posted
October 28, 2015
Study Start
December 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
March 31, 2016
Record last verified: 2016-03