NCT00464295已完成2 期
Phase II Trial of Capecitabine for the Treatment of Unresectable/ Metastatic or Advanced Hepatocellular Carcinoma(HCC)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- To evaluate response rate and overall survival after completing minimum of three cycles of Capecitabine in Advance HCC
研究概览
简要总结
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.
详细描述
II. OBJECTIVES
II.A. Primary Objectives: To evaluate response rate (RR) and overall survival (OS).
II.B. Secondary Objective: To evaluate the time to progression (TTP), median time to response (MTR), toxicity and quality of life (QOL).
III. STUDY DESIGN:
III.A. Inclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent.
- •Age between 18 and 70 years.
- •Documented by at least 2 out of three mentioned criteria and evidence of non-resectability.
- •Radiological either CT Scan/US abdomen
- •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
- •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 <
- •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.
排除标准
- •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
- •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.
结局指标
主要结局
To evaluate response rate and overall survival after completing minimum of three cycles of Capecitabine in Advance HCC
时间窗: 12 months from the start of chemotherapy
次要结局
- To evaluate the time to progression, toxicity and quality of life for patients on chemotherapy(12 months)
研究者
研究点 (2)
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