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Status unknownNCT02588755Updated Mar 31, 2016

TACE Plus Tegafur Versus TACE for Intrahepatic Cholangiocarcinoma After Curative Resection

An interventional study of TACE+Tegafur and TACE in Intrahepatic Cholangiocarcinoma, sponsored by Eastern Hepatobiliary Surgery Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-03-31.

Sponsored by Eastern Hepatobiliary Surgery Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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

02

Conditions studied

  • Intrahepatic Cholangiocarcinoma

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Keywords

  • Chemoembolization
  • Therapeutic
  • Tegafur
03

In context

Cholangiocarcinoma

914 studies on the registry are indexed under Cholangiocarcinoma; 286 are open to participants now.

This study's planned enrollment of 180 is above the median of 50 across 687 interventional studies indexed under Cholangiocarcinoma.

Browse Cholangiocarcinoma studies →

Lead sponsor

Eastern Hepatobiliary Surgery Hospital is the lead sponsor of 66 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
180 participants (estimated)

Study arms

  • 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

  • Experimental
    TACE

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

    Procedure: TACE

Interventions

  • ProcedureTACE+Tegafur

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

    Also known as: TACE followed by Tegafur

  • ProcedureTACE

    TACE alone

06

What researchers measure

Primary outcomes

  1. Overall survival rates of each group

    Time frame: 3 years

Secondary outcomes

  1. Occurrence rate of recurrence of each group

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
  • Eastern hepatobilliary surgery hospital
    Shanghai, Shanghai 200438, China
    • Shen Feng, MD · Contact · shenfengdfgd@yahoo.com.cn · 0086-021-25070805
    • Yong Xia, Doctor · Contact · 86-021-81875495
    • Shen Feng, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02588755
Lead sponsor
Eastern Hepatobiliary Surgery Hospital
Responsible party
ShenFeng (vice president of the Eastern Hepatobiliary Surgery Hospital, Eastern Hepatobiliary Surgery Hospital) — Principal investigator
First posted
Oct 28, 2015
Start date
Dec 2015
Primary completion
Dec 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Mar 31, 2016

Study contacts

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

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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