TACE Plus Tegafur Versus TACE for Intrahepatic Cholangioc... | NCT02588755

Studies
TACE Plus Tegafur Versus TACE for Intrahepatic Cholangiocarcinoma After Curative Resection

NCT02588755

Sponsor

Eastern Hepatobiliary Surgery Hospital

Status

Unknown status

Last Update Posted

Mar 31, 2016Estimated

Enrollment

180Estimated

Phase

Not Applicable

Conditions

Intrahepatic Cholangiocarcinoma

Interventions

TACE+Tegafur
TACE

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2015

Primary Completion Date

Dec 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Oct 27, 2015

First Submission Date that Met QC Criteria

Oct 27, 2015

First Posted Date

Oct 28, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2016

Last Update Posted Date

Mar 31, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

ShenFeng, vice president of the Eastern Hepatobiliary Surgery Hospital, Eastern Hepatobiliary Surgery HospitalPrincipal Investigator

Lead Sponsor

Eastern Hepatobiliary Surgery HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TACE+ Tegafur	Active Comparator	Patients will be treated with Tegafur after resection soon, and TACE in 4 or 8 weeks after resection.	Procedure: TACE+Tegafur
TACE	Experimental	Patients will be treated with TACE alone in 4 or 8 weeks after resection.	Procedure: TACE

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TACE+Tegafur	Procedure	Tegafur: 40mg bid for 3 continuous months in 4 months. TACE: 4 or 8 weeks after resection.	TACE+ Tegafur

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival rates of each group		3 years

Secondary Outcomes

Measure	Description	Time Frame
Occurrence rate of recurrence of each group		3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wang Kui, MD	Contact	+86-021-81875242		wangkuiykl@163.com
Shen Feng, MD	Contact	0086-021-25070805		shenfengdfgd@yahoo.com.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eastern hepatobilliary surgery hospital	Recruiting	Shanghai	Shanghai Municipality	200438	China

Condition Browse Module

MeSH Terms

ID	Term
D018281	Cholangiocarcinoma

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided