TACE Plus Tegafur Versus TACE for Intrahepatic Cholangiocarcinoma After Curative Resection

Naval Military Medical University (Second Military Medical University)

Status: Unknown

Conditions: Intrahepatic Cholangiocarcinoma

Treatments: Procedure: TACE; Procedure: TACE+Tegafur

Study type: Interventional

Funder types: Other

Identifiers

NCT02588755

EHBHKY2015-0123

Details and patient eligibility

About

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

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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180 participants in 2 patient groups

TACE+ Tegafur

Active Comparator group

Description:

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

Treatment:

Procedure: TACE+Tegafur

TACE

Experimental group

Description:

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

Treatment:

Procedure: TACE