None listed
Conditions
Brief summary
Postoperative recurrence of intrahepatic cholangiocellular carcinoma (ICC) is a major problem that hampers the efficacy of surgical resection. To date, adjuvant chemotherapy or other adjuvant modalities have not been proven effective for ICC. We conducted a randomized controlled trial to investigate whether adjuvant therapy with capecitabine after the operation could inhibit the recurrence of ICC after curative resection.
Interventions
After one month of the curative resection, the adjuvant group received 1250mg/m2 capecitabine tablets two times per one day by oral; Taking two weeks and have one week dicontinuation as one course of treatment, repeated six courses. The monthly review of the blood, liver, renal, CA-19-9, alpha-fetoprotein (AFP) and liver ultrasound. The three-monthly review of liver-enhanced CT or MRI. If bone pain, line ECT or check.
adverse reactions processing program:
a. Grade III adverse reactions: capecita
After one month of the curative resection, the adjuvant group received 1250mg/m2 capecitabine tablets two times per one day by oral; Taking two weeks and have one week dicontinuation as one course of treatment, repeated six courses. The monthly review of the blood, liver, renal, CA-19-9, alpha-fetoprotein (AFP) and liver ultrasound. The three-monthly review of liver-enhanced CT or MRI. If bone pain, line ECT or check. adverse reactions processing program: a. Grade III adverse reactions: capecitabine dose reduced 25% b. Grade III adverse reactions last more than 2 weeks or grade IV adverse reactions: stop taking capecitabine c. WBC <2.5 × 109 / L and/or PLT <40 × 109 / L: capecitabine dose reduced 25% and give drugs which can rised white blood cells and/or platelet counts d. WBC and/or platelet count still continued to decline after the dose of capecitabine reduced: stop taking capecitabine A standardized clinical data management procedure will be carried out to make sure all of the data including the data on the adherences satisfy good clinical practice (GCP) requirements. All of the data will be entered in a verified database while the original paper records will be kept for at least 5 years. To make sure that the data in the database is consistent with the original one, a data validation process will be carried out. Disagreements were adjudicated by answering the query forms after referring to the original records.
Sponsors
The Eastern Hepatobiliary Surgery Hospital
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Outcome results
None listed