TACE Plus Tegafur Versus TACE for Intrahepatic Cholangiocarcinoma After Curative Resection

Not Applicable

• Conditions: Intrahepatic Cholangiocarcinoma
• Interventions: Procedure: TACE+Tegafur; Procedure: TACE

• Registration Number: NCT02588755
• Lead Sponsor: Eastern Hepatobiliary Surgery Hospital

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-27
• Study First Submitted QC: 2015-10-27
• Study First Posted: 2015-10-28
• Study Start: 2015-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-30
• Last Update Posted: 2016-03-31
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TACE+ Tegafur	TACE+Tegafur	Patients will be treated with Tegafur after resection soon, and TACE in 4 or 8 weeks after resection.
TACE	TACE	Patients will be treated with TACE alone in 4 or 8 weeks after resection.

Primary Outcome Measures

Name	Time	Method
Overall survival rates of each group	3 years

Secondary Outcome Measures

Name	Time	Method
Occurrence rate of recurrence of each group	3 years

Trial Locations

Locations (1)

Eastern hepatobilliary surgery hospital; 🇨🇳 Shanghai, Shanghai, China