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Phase II Trial of Capecitabine for the Treatment of Unresectable/ Metastatic or Advanced Hepatocellular Carcinoma(HCC) (HCC-CAP)

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: NCT00464295
Recruitment Status : Completed
First Posted : April 23, 2007
Last Update Posted : December 14, 2007
Information provided by:
Aga Khan University

Brief Summary:
In patients with unresectable/advanced Hepatocellular Carcinoma receiving Capecitabin, we anticipate that the proposed chemotherapy will have a delay in progression of the disease . It is also expected that proposed chemotherapy will have acceptable toxicity and Quality of life.

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Drug: Capecitabine in HCC Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Capecitabine for the Treatment of Unresectable/ Metastatic or Advanced Hepatocellular Carcinoma(HCC)
Study Start Date : August 2006
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. To evaluate response rate and overall survival after completing minimum of three cycles of Capecitabine in Advance HCC [ Time Frame: 12 months from the start of chemotherapy ]

Secondary Outcome Measures :
  1. To evaluate the time to progression, toxicity and quality of life for patients on chemotherapy [ Time Frame: 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  • Written informed consent.
  • Age between 18 and 70 years.
  • Documented by at least 2 out of three mentioned criteria and evidence of non-resectability.

    1. Radiological either CT Scan/US abdomen
    2. Biopsy,
    3. Serum alphafeto protein level
  • Multi centric hepatoma or TNM Classification Stage IV.
  • Child's class B or C with a Child's score of maximum 11.
  • No other active malignancy except localized basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
  • Life expectancy of greater then 3 months.
  • Current laboratory values must be within the limits listed below:

Haemoglobin > 8 g/dL WBC > 4,000/uL Absolute Neutrophil Count > 1,500/uL Platelets > 75,000/uL

  • ECOG Performance status of < 2.
  • Patients who have received adjuvant or neoadjuvant therapy are eligible. A minimum interval of 4 weeks since last chemotherapy will be required.
  • Prior radiotherapy will be allowed if it did not involve a site used to assess response and 4 weeks have elapsed since completion of radiotherapy.

Exclusion Criteria:

  • History of allergic reaction to compound chemically related to CAP.
  • Concomitant or previous malignancies within five years other than basal or squamous cell carcinoma of the skin and carcinoma in situ of the cervix.
  • Active, uncontrolled infection. .
  • Concurrent medical problems which could limit the life expectancy or the ability of the patient to receive chemotherapy.
  • Mental condition that could limit the patient in comprehending the concept of clinical trial or complying with its requirements.
  • Brain or leptomeningeal involvement.
  • Pre-existing neurotoxicity of >=grade 2.
  • Concomitant radiotherapy, unless localised for bone pain control or palliation.
  • Being of reproductive potential and not agreeing to practice an effective contraceptive method.
  • Pregnancy or lactation.
  • Severe renal impairment with Creatinine clearance <30ml/minute.
  • Documented Cardiomyopathy or severe coronary artery disease, or history of arrhythmias.

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): NCT00464295

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Aga Khan University
Karachi, Sind, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
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Principal Investigator: Muhammad K Anis, MD Aga Khan University
Principal Investigator: Zaigham Abbas, MD Aga Khan University
Study Director: Wasim Jafri, MD Aga Khan University
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Responsible Party: Muhammad Kashif Anis, Aga Khan University Identifier: NCT00464295    
Other Study ID Numbers: 449-Med/ERC-05
First Posted: April 23, 2007    Key Record Dates
Last Update Posted: December 14, 2007
Last Verified: December 2007
Keywords provided by Aga Khan University:
Hepatocellular Carcinoma
Phase 2 Trial
Treatment Efficacy
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents