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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
Postoperative adjuvant treatment with Capecitabine postpones recurrence of hepatocellular carcinoma after curative resection: a randomized controlled trial
Scientific title
A prospective randomized controlled trial comparing recurrence outcome of adjuvant capecitabine therapy versus no adjuvant therapy for patients with hepatocellular carcinoma after curative resection
Secondary ID [1] 919 0
Chinese Clinical Trial Register
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatocellular carcinoma 237195 0
Condition category
Condition code
Cancer 237518 237518 0 0

Study type
Description of intervention(s) / exposure
Beginning 3 to 4 weeks post operation, the capecitabine group received two weeks of capecitabine oral tablet at 1000 mg/m2, twice a day, 30 min after breakfast and dinner (Xeloda, 500 mg/tablet, Roche, Shanghai, China) followed by one week of rest. This three week regimen was repeated for a total of 4 to 6 cycles.
Intervention code [1] 236900 0
Treatment: Drugs
Comparator / control treatment
The control group received no adjuvant therapy for 18 weeks
Control group

Primary outcome [1] 238326 0
Time to recurrence (TTR)

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.
Timepoint [1] 238326 0
Time from curative hepatectomy to the first diagnosis of tumor recurrence.
Primary outcome [2] 238327 0
Overall survival (OS)
Timepoint [2] 238327 0
Every year after randomization for 5 years
Secondary outcome [1] 244706 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] 244706 0
Every year after randomization for 5 years

Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
70 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
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
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Drawing consecutively numbered sealed envelopes and implementation was ensured by a research assistant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 2 / Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 1872 0
State/province [1] 1872 0

Funding & Sponsors
Funding source category [1] 237296 0
Name [1] 237296 0
Eastern Hepatobiliary Surgery Hospital
Address [1] 237296 0
No.225 Changhai Road, Shanghai 200438, China
Country [1] 237296 0
Primary sponsor type
Eastern Hepatobiliary Surgery Hospital
No.225 Changhai Road, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai 200438, China
Secondary sponsor category [1] 236779 0
Name [1] 236779 0
Second Military Medical University
Address [1] 236779 0
No.800 Xiangyin Road, Shanghai 200433, China
Country [1] 236779 0

Ethics approval
Ethics application status
Ethics committee name [1] 239381 0
Institutional Review Board of Shanghai Eastern Hepatobiliary Surgery Hospital
Ethics committee address [1] 239381 0
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai 200438, China
Ethics committee country [1] 239381 0
Date submitted for ethics approval [1] 239381 0
Approval date [1] 239381 0
Ethics approval number [1] 239381 0

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 postoperative adjuvant therapy with capecitabine could inhibit the recurrence of HCC after radical resection.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 29862 0
Address 29862 0
Country 29862 0
Phone 29862 0
Fax 29862 0
Email 29862 0
Contact person for public queries
Name 13109 0
XIA Yong
Address 13109 0
No.225 Changhai Road, Shanghai 200438,China
Country 13109 0
Phone 13109 0
Fax 13109 0
Email 13109 0
Contact person for scientific queries
Name 4037 0
XIA Yong
Address 4037 0
No.225 Changhai Road, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University,Shanghai 200438,China
Country 4037 0
Phone 4037 0
Fax 4037 0
Email 4037 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary