Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2025-12-24 @ 1:30 PM
NCT ID:
NCT00464295
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00464295
Study Brief:
Protocol Section:
NCT00464295