TACE Plus Tegafur Versus TACE for Intrahepatic Cholangiocarcinoma After Curative Resection

Sponsor

Eastern Hepatobiliary Surgery Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02588755

Collaborator

(none)

180

Enrollment

Location

Arms

Duration (Months)

7.5

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Intrahepatic Cholangiocarcinoma	Procedure: TACE+Tegafur Procedure: TACE	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Dec 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: TACE+ Tegafur Patients will be treated with Tegafur after resection soon, and TACE in 4 or 8 weeks after resection.	Procedure: TACE+Tegafur Tegafur: 40mg bid for 3 continuous months in 4 months. TACE: 4 or 8 weeks after resection. Other Names: TACE followed by Tegafur
Experimental: TACE Patients will be treated with TACE alone in 4 or 8 weeks after resection.	Procedure: TACE TACE alone

Arm

Intervention/Treatment

Active Comparator: TACE+ Tegafur

Patients will be treated with Tegafur after resection soon, and TACE in 4 or 8 weeks after resection.

Procedure: TACE+Tegafur

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

Other Names:

TACE followed by Tegafur

Experimental: TACE

Patients will be treated with TACE alone in 4 or 8 weeks after resection.

Procedure: TACE

TACE alone

Outcome Measures

Primary Outcome Measures

Overall survival rates of each group [3 years]

Secondary Outcome Measures

Occurrence rate of recurrence of each group [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.