Capecitabine to Prevent Recurrence of Hepatocellular Carcinoma After Curative Resection
Capecitabine as Adjuvant Chemotherapy to Prevent Recurrence of Hepatocellular Carcinoma After Curative Resection: a Randomized Controlled Trial
1 other identifier
interventional
290
1 country
1
Brief Summary
The purpose of this study is to determine whether capecitabine is effective to prevent disease recurrence after curative hepatic resection in patients with hepatocellular carcinoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hepatocellular-carcinoma
Started Nov 2007
Longer than P75 for phase_2 hepatocellular-carcinoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 20, 2007
CompletedFirst Posted
Study publicly available on registry
November 21, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedJuly 21, 2010
August 1, 2009
4.7 years
November 20, 2007
July 20, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary end point was to determine the effect on disease-free survival and overall survival by oral capecitabine.
four years
Secondary Outcomes (1)
The secondary end point was to analyze the relationship between preventive effectiveness of capecitabine with thymidine phosphorylase expression level of tumor tissue.
four years
Study Arms (2)
Intervention treatment
EXPERIMENTALCapecitabine
No intervention treatment
NO INTERVENTIONNo other preventive treatment
Interventions
Capecitabine 1,250 mg/m2 twice daily on days 1-14, followed by a 7-day drug-free interval. Treatment repeats every 21 days. The above cycle is repeated for 4-6 times.If disease recurrence or unacceptable toxicity or other criteria for withdrawal are met, treatment will be stopped.
Eligibility Criteria
You may qualify if:
- First curative hepatic resection
- Hepatocellular Carcinoma (histologically confirmed)
- Cirrhosis of Child-Pugh class A or B
- A performance status ≤ 2
- Adequate bone marrow ,hepatic and renal functions (white blood cell (WBC) count \> 2.5×10\^3/μL, platelet count \> 40×10\^3/μL, a serum bilirubin level, alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2 times the upper limit of the normal value, and serum creatinine level \< 1.5 mg/dL)
- Major organ (heart, lung and brain) function was normal
- An age between 18 and 79 years.
You may not qualify if:
- Any active infectious process
- Known hypersensitivity to capecitabine
- The presence of clinically confirmed extrahepatic metastasis, macroscopic evidence of tumor thrombus in the inferior vena cava or the main portal vein or the main bile duct
- Other previous or synchronous malignant disorders
- Postoperative dysfunction of any organ.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jian Zhou, M.D.
Fudan University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 20, 2007
First Posted
November 21, 2007
Study Start
November 1, 2007
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
July 21, 2010
Record last verified: 2009-08