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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
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Scientific title
The effect of adjuvant therapy with aspirin on relapse prevention of hepatocellular carcinoma after curative resection: A prospective randomized controlled trial
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Secondary ID [1]
282329
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none
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
recurrence of hepatocellular carcinoma with microvascular tumor thrombus after curative resection
288876
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Condition category
Condition code
Cancer
289217
289217
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0
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Liver
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
286944
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Treatment: Drugs
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
289328
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Timepoint [1]
289328
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Time from curative resection to the first diagnosis of tumor recurrence
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Primary outcome [2]
289329
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Overall survival: Time from operation to death. Patients alive at the end of follow-up are surveyed via patient census
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Assessment method [2]
289329
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Timepoint [2]
289329
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Every year after operation for 2 years
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Secondary outcome [1]
302249
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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.
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Assessment method [1]
302249
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Timepoint [1]
302249
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Every year after randomization for 2 years
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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.
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/06/2013
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
120
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
5013
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China
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State/province [1]
5013
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Shanghai
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Funding & Sponsors
Funding source category [1]
287085
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Self funded/Unfunded
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Name [1]
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Address [1]
287085
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Country [1]
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China
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Primary sponsor type
Hospital
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Name
Estern hepatobiliary surgery hospital
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Address
No.225, Changhai Road, Yangpu District, Shanghai, 200438
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Country
China
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Secondary sponsor category [1]
285860
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None
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Name [1]
285860
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Address [1]
285860
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Country [1]
285860
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289144
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Verification of Clinical Research Ethics Committee
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Ethics committee address [1]
289144
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No.225, Changhai Road, Yangpu District, Shanghai, 200438
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Ethics committee country [1]
289144
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China
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Date submitted for ethics approval [1]
289144
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22/02/2012
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Approval date [1]
289144
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01/04/2013
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Ethics approval number [1]
289144
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EHBHKY2013-001—07
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Summary
Brief summary
Postoperative recurrence of hepatocellular carcinoma (HCC) 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 HCC. We conducted a randomized controlled trial to investigate whether adjuvant therapy with aspirin after the operation could inhibit the recurrence of HCC after curative resection.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Yang Jiamei
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Address
39250
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Estern Hepatobiliary Surgery Hospital, NO.225, Changhai Road, Shanghai, 200438
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Country
39250
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China
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Phone
39250
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+8602181875554
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Fax
39250
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Email
39250
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[email protected]
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Contact person for public queries
Name
39251
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Dr Li Yesheng
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Address
39251
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Estern Hepatobiliary Surgery Hospital, NO.225, Changhai Road, Shanghai, 200438
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Country
39251
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China
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Phone
39251
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+8602181875554
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Fax
39251
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Email
39251
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[email protected]
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Contact person for scientific queries
Name
39252
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Dr Li Yesheng
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Address
39252
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Estern Hepatobiliary Surgery Hospital, NO.225, Changhai Road, Shanghai, 200438
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Country
39252
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China
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Phone
39252
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+8602181875554
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Fax
39252
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Email
39252
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[email protected]
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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.
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