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Capecitabine as Adjuvant Chemotherapy to Prevent Recurrence of Hepatocellular Carcinoma After Curative Resection: a Randomized Controlled Trial

Phase 2/Phase 3
18 Years
79 Years
Open (Enrolling)
Hepatocellular Carcinoma, Neoplasm Metastasis

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Trial Information

Capecitabine as Adjuvant Chemotherapy to Prevent Recurrence of Hepatocellular Carcinoma After Curative Resection: a Randomized Controlled Trial

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.

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

- Other previous or synchronous malignant disorders

- Postoperative dysfunction of any organ.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary end point was to determine the effect on disease-free survival and overall survival by oral capecitabine.

Outcome Time Frame:

four years

Safety Issue:


Principal Investigator

Jian Zhou, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Fudan University


China: Ethics Committee

Study ID:




Start Date:

November 2007

Completion Date:

July 2012

Related Keywords:

  • Hepatocellular Carcinoma
  • Neoplasm Metastasis
  • Recurrence
  • Metastasis
  • Hepatocellular Carcinoma
  • Radical Hepatic Resection
  • Drug Prevention
  • Capecitabine
  • Surgery
  • Neoplasms
  • Carcinoma
  • Neoplasm Metastasis
  • Recurrence
  • Carcinoma, Hepatocellular