Postoperative adjuvant treatment with Capecitabine postpones recurrence of hepatocellular carcinoma after curative resection: a randomized controlled trial
- Conditions
- Hepatocellular carcinomaCancer - Liver
- Registration Number
- ACTRN12609000574246
- Lead Sponsor
- Eastern Hepatobiliary Surgery Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
Patients whose age ranged from 18 to 70 years, with histologically proven hepatocellular carcinoma, and who underwent curative hepatectomy with less than 50% of the liver and with a tumor-free resection margin greater than 1 cm ;a postoperative decline of alpha-fetoprotein (AFP) level to less than 20 micro g/L; Child-Pugh class A; normalized hepatic function (glutamic pyruvic transaminase/glutamic oxaloacetic transaminase (GPT/GOT) 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 equal to 2500×109/L; platelet count (PTL) equal to 40×109/L); life expectancy longer than 6 months; Karnofsky Performance Scale (KPS) score egual to 70.
Prior therapy with capecitabine, concomitant chemotherapy, allergy or history of severe adverse reactions to 5-fluoro-2,4(1H,3H)pyrimidinedione, bone or cerebral metastases, and malignant tumors in other regions of the body over the previous five 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, or upper digestive tract disorders; Pregnant or lactating females and pre-menopausal women without using contraception.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to recurrence (TTR)<br><br>Recurrence was confirmed by dynamic contrast-enhanced Computerised Tomography scanning or selective hepatic arteriography in subjects with an elevated alpha-fetoprotein level or with a newly identified mass.[Time from curative hepatectomy to the first diagnosis of tumor recurrence.];Overall survival (OS)[Every year after randomization for 5 years]
- Secondary Outcome Measures
Name Time Method Disease-free survival (DFS)<br>Disease-free survival:Time from randomization to either recurrence or death. Patients alive and free of recurrence at the end of follow-up are surveyed via patient census.[Every year after randomization for 5 years]