Intrahepatic Cholangiocarcinoma
Conditions
Keywords
Chemoembolization, Therapeutic, Tegafur
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
Interventions
PROCEDURETACE+Tegafur
Tegafur: 40mg bid for 3 continuous months in 4 months. TACE: 4 or 8 weeks after resection.
PROCEDURETACE
TACE alone
Sponsors
Eastern Hepatobiliary Surgery Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival rates of each group | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence rate of recurrence of each group | 3 years |
Countries
China
Contacts
Primary ContactWang Kui, MD
Backup ContactShen Feng, MD
Outcome results
None listed