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

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.