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Trial registered on ANZCTR


Registration number
ACTRN12613000520730
Ethics application status
Approved
Date submitted
13/04/2013
Date registered
10/05/2013
Date last updated
10/05/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of adjuvant therapy with aspirin on relapse prevention of hepatocellular carcinoma after curative resection: A prospective randomized controlled trial
Scientific title
The effect of adjuvant therapy with aspirin on relapse prevention of hepatocellular carcinoma after curative resection: A prospective randomized controlled trial
Secondary ID [1] 282329 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
recurrence of hepatocellular carcinoma with microvascular tumor thrombus after curative resection 288876 0
Condition category
Condition code
Cancer 289217 289217 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After 1 month of the curative resection, the adjuvant group received 100mg aspirin tablet one time per one day by oral until tumor recurrence confirmed by Liver contrast-enhanced CT or MRI tumor with or without elevated AFP or 2 years after operation or the patient death during the study.
The monthly review after the blood, liver, kidney function, alpha-fetoprotein (AFP) and liver ultrasound. The three-monthly review of liver-enhanced CT or MRI. If bone pain, line ECT or check
The processing schedule of Adverse reactions:
a. Grade III adverse reactions: aspirin dose reduced by 50%;
b. Grade III adverse reactions are continued more than 2 weeks or Grade IV adverse reactions: stop taking aspirin
c. When WBC <2.5 × 109 / L and/or PLT <40 × 109 / L: aspirin dose reduced by 50% and get drugs which can enhance white blood cells and/or platelet count;
d. When the dose of aspirin reduced but WBC and/or platelet count continued to decline: stop taking aspirin

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.
Intervention code [1] 286944 0
Treatment: Drugs
Comparator / control treatment
After R0 resection, according to NCCN guideline 2012 of hepatobiliary cancers, there is no definite treatment for patients. So the control group will get best support treatment.
Control group
Active

Outcomes
Primary outcome [1] 289328 0
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
Timepoint [1] 289328 0
Time from curative resection to the first diagnosis of tumor recurrence
Primary outcome [2] 289329 0
Overall survival: Time from operation to death. Patients alive at the end of follow-up are surveyed via patient census
Timepoint [2] 289329 0
Every year after operation for 2 years
Secondary outcome [1] 302249 0
Disease-free survival (DFS)
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.
Timepoint [1] 302249 0
Every year after randomization for 2 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 5013 0
China
State/province [1] 5013 0
Shanghai

Funding & Sponsors
Funding source category [1] 287085 0
Self funded/Unfunded
Name [1] 287085 0
Country [1] 287085 0
China
Primary sponsor type
Hospital
Name
Estern hepatobiliary surgery hospital
Address
No.225, Changhai Road, Yangpu District, Shanghai, 200438
Country
China
Secondary sponsor category [1] 285860 0
None
Name [1] 285860 0
Address [1] 285860 0
Country [1] 285860 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289144 0
Verification of Clinical Research Ethics Committee
Ethics committee address [1] 289144 0
Ethics committee country [1] 289144 0
China
Date submitted for ethics approval [1] 289144 0
22/02/2012
Approval date [1] 289144 0
01/04/2013
Ethics approval number [1] 289144 0
EHBHKY2013-001—07

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39250 0
Prof Yang Jiamei
Address 39250 0
Estern Hepatobiliary Surgery Hospital, NO.225, Changhai Road, Shanghai, 200438
Country 39250 0
China
Phone 39250 0
+8602181875554
Fax 39250 0
Email 39250 0
yangjiamei2010@163.com
Contact person for public queries
Name 39251 0
Li Yesheng
Address 39251 0
Estern Hepatobiliary Surgery Hospital, NO.225, Changhai Road, Shanghai, 200438
Country 39251 0
China
Phone 39251 0
+8602181875554
Fax 39251 0
Email 39251 0
leeyesheng@163.com
Contact person for scientific queries
Name 39252 0
Li Yesheng
Address 39252 0
Estern Hepatobiliary Surgery Hospital, NO.225, Changhai Road, Shanghai, 200438
Country 39252 0
China
Phone 39252 0
+8602181875554
Fax 39252 0
Email 39252 0
leeyesheng@163.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.