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Trial record 8 of 21 for:    TYMP

Capecitabine to Prevent Recurrence of Hepatocellular Carcinoma After Curative Resection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00561522
Recruitment Status : Unknown
Verified August 2009 by Fudan University.
Recruitment status was:  Active, not recruiting
First Posted : November 21, 2007
Last Update Posted : July 21, 2010
Information provided by:
Fudan University

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Neoplasm Metastasis Drug: Capecitabine Other: No other preventive treatment Phase 2 Phase 3

Detailed Description:
Hepatocellular carcinoma (HCC) accounts for 70-90% of primary liver cancers, which is the third most common cause of death from cancer worldwide; over half a million new cases are diagnosed worldwide each year. Hepatic resection has been established as one of the most effective and safe therapeutic options for HCC. However, recurrence, particularly metastatic recurrence, is one of the major obstacles to long-term survival. Several adjuvant treatments have been used to prevent recurrence after surgery, but their effectiveness remains controversial. Fluorouracil (FU), an antimetabolite, is a commonly used chemotherapeutic agent, with activity in a variety of solid tumors including those of the head and neck, breast, prostate, pancreas, liver, and genitourinary and gastrointestinal tracts. Capecitabine (Xeloda; Roche), a novel prodrug of 5-FU, is an orally administered tumor-selective cytotoxic agent that is converted to 5-FU by three enzymes. Capecitabine has the advantages of convenient oral administration and of mimicking the effect of protracted intravenous (i.v.) 5-FU. Capecitabine is currently approved by the FDA for use as first-line therapy in patients with metastatic colorectal cancer when single-agent fluoropyrimidine therapy is preferred. The drug is also approved for use as a single agent in metastatic breast cancer patients who are resistant to both anthracycline- and paclitaxel-based regimens or in whom further anthracycline treatment is contraindicated. Our previous study found that PD-ECGF mRNA was highly expressed in human HCC and particularly in portal vein tumor thrombus as compared with noncancerous liver tissues. Capecitabine inhibits tumor growth and metastatic recurrence after resection of HCC in highly metastatic nude mice model. The effect of capecitabine may be attributed to the high expression of PD-ECGF in tumors. The antitumor activity of single-agent capecitabine was modest in patients with HCC, including those with cirrhosis. Von Delius et al reported that capecitabine was found to be safe for treatment of patients with HCC, including those with compensated cirrhosis. On the basis of previous findings, we designed a randomized, controlled trial to test the hypothesis that adjuvant postoperative chemotherapy with capecitabine can prevent tumor recurrence after radical hepatic resection in patients with HCC. Because capecitabine is administered orally, we considered that this treatment would be clinically useful if its effectiveness could be confirmed.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Capecitabine as Adjuvant Chemotherapy to Prevent Recurrence of Hepatocellular Carcinoma After Curative Resection: a Randomized Controlled Trial
Study Start Date : November 2007
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Intervention treatment
Drug: Capecitabine
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.

No Intervention: No intervention treatment
No other preventive treatment
Other: No other preventive treatment
No other preventive treatment

Primary Outcome Measures :
  1. The primary end point was to determine the effect on disease-free survival and overall survival by oral capecitabine. [ Time Frame: four years ]

Secondary Outcome Measures :
  1. The secondary end point was to analyze the relationship between preventive effectiveness of capecitabine with thymidine phosphorylase expression level of tumor tissue. [ Time Frame: four years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00561522

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China, Shanghai
Zhongshan Hospital, Fudan University
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
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Study Director: Jian Zhou, M.D. Fudan University

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Responsible Party: Zhongshan Hospital Identifier: NCT00561522     History of Changes
Other Study ID Numbers: 2007-07-RCT-LCI1
First Posted: November 21, 2007    Key Record Dates
Last Update Posted: July 21, 2010
Last Verified: August 2009
Keywords provided by Fudan University:
Hepatocellular Carcinoma
Radical Hepatic Resection
Drug Prevention
Additional relevant MeSH terms:
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Neoplasm Metastasis
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplastic Processes
Pathologic Processes
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Disease Attributes
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents