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

This study has been completed.
Information provided by:
Aga Khan University Identifier:
First received: April 20, 2007
Last updated: December 13, 2007
Last verified: December 2007
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 Intervention Phase
Carcinoma, Hepatocellular Drug: Capecitabine in HCC Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Capecitabine for the Treatment of Unresectable/ Metastatic or Advanced Hepatocellular Carcinoma(HCC)

Resource links provided by NLM:

Further study details as provided by Aga Khan University:

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

Enrollment: 15
Study Start Date: August 2006
Study Completion Date: October 2007
  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00464295

Aga Khan University
Karachi, Sind, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
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
  More Information

Responsible Party: Muhammad Kashif Anis, Aga Khan University Identifier: NCT00464295     History of Changes
Other Study ID Numbers: 449-Med/ERC-05
Study First Received: April 20, 2007
Last Updated: December 13, 2007

Keywords provided by Aga Khan University:
Hepatocellular Carcinoma
Phase 2 Trial
Treatment Efficacy

Additional relevant MeSH terms:
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 processed this record on June 23, 2017