A randomized controlled trial to evaluate the effectiveness of capecitabine as a postoperative adjuvant regimen in inhibiting the recurrence of intrahepatic cholangiocarcinoma after curative resection

The Eastern Hepatobiliary Surgery Hospital0 sites120 target enrollmentMay 10, 2013

Overview

No summary available.

Registry

who.int

Start Date

May 10, 2013

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

The Eastern Hepatobiliary Surgery Hospital

•Patients whose age ranged from 18 to 70 years, with histologically proven intrahepatic cholangiocellular carcinoma, and who underwent curative hepatectomy with less than 50% of the liver and with a tumor\-free resection margin greater than 1 cm; Child\-Pugh class A; normalized hepatic function (glutamic pyruvic transaminase/glutamic oxaloacetic transaminase (GPT/GOT) less than or equal to 2 times the upper normal limit; total serum bilirubin less than 34\.2 micro mol/L); normal renal function and hematological parameters (serum creatinine less than 132 micro mol/L; white blood cell (WBC) count greater than or equal to 2\.5×109/L; platelet count (PLT) greater than or equal to 40×109/L); life expectancy longer than 6 months.

•Prior therapy with chemotherapy, allergy or history of severe adverse reactions to capecitabine, the other region metastases, and malignant tumors in other regions of the body over the previous two years; peripheral neuropathy, history of central nervous system diseases, abnormal electrocardiogram findings, psychiatric disorders; severe cardiac, metabolic and/or infectious diseases; active peptic ulcer disease requiring treatment, absorption disorders; Pregnant or lactating females.