The effect of adjuvant therapy with aspirin on relapse prevention of hepatocellular carcinoma after curative resection: A prospective randomized controlled trial

• Conditions: recurrence of hepatocellular carcinoma with microvascular tumor thrombus after curative resection; Cancer - Liver

• Registration Number: ACTRN12613000520730
• Lead Sponsor: Estern hepatobiliary surgery hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Patients whose age ranged from 18 to 70 years, with histologically proven heptocellular 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 aspirin, 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence was confirmed by dynamic contrast-enhanced Computerised Tomography scan or selective hepatic arteriography in subjects with an elevated AFP level or with a newly identified mass[Time from curative resection to the first diagnosis of tumor recurrence];Overall survival: Time from operation to death. Patients alive at the end of follow-up are surveyed via patient census[Every year after operation for 2 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 2 years]