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NCT02588755 Clinical Trial

TACE Plus Tegafur Versus TACE for Intrahepatic Cholangiocarcinoma After Curative Resection

Intrahepatic Cholangiocarcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02588755
Other study ID # EHBHKY2015-0123
Secondary ID
Status Recruiting
Phase N/A
First received October 27, 2015
Last updated March 30, 2016
Start date December 2015
Est. completion date December 2017

Study information
Verified date March 2016
Source Eastern Hepatobiliary Surgery Hospital
Contact Wang Kui, MD
Phone +86-021-81875242
Email wangkuiykl@163.com
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 180
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• TACE+Tegafur
Tegafur: 40mg bid for 3 continuous months in 4 months. TACE: 4 or 8 weeks after resection.
• TACE
TACE alone

Locations
Country Name City State
China Eastern hepatobilliary surgery hospital Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Eastern Hepatobiliary Surgery Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival rates of each group 3 years No
Secondary Occurrence rate of recurrence of each group 3 years No
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