TACE Plus Tegafur Versus TACE for Intrahepatic Cholangiocarcinoma After Curative Resection

NCT ID: NCT02588755

Last Updated: 2016-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-12-31

Brief Summary

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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

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Conditions

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Intrahepatic Cholangiocarcinoma

Keywords

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Chemoembolization Therapeutic Tegafur

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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TACE+ Tegafur

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

Group Type ACTIVE_COMPARATOR

TACE+Tegafur

Intervention Type PROCEDURE

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

TACE

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

Group Type EXPERIMENTAL

TACE

Intervention Type PROCEDURE

TACE alone

Interventions

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TACE+Tegafur

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

Intervention Type PROCEDURE

TACE

TACE alone

Intervention Type PROCEDURE

Other Intervention Names

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TACE followed by Tegafur

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eastern Hepatobiliary Surgery Hospital

OTHER

Sponsor Role lead

Responsible Party

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ShenFeng

vice president of the Eastern Hepatobiliary Surgery Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wang Kui, MD

Role: CONTACT

Phone: +86-021-81875242

Email: [email protected]

Shen Feng, MD

Role: CONTACT

Phone: 0086-021-25070805

Email: [email protected]

Facility Contacts

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Shen Feng, MD

Role: primary

Yong Xia, Doctor

Role: backup

Other Identifiers

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EHBHKY2015-0123

Identifier Type: -

Identifier Source: org_study_id