NCT00516945已完成不适用
A Randomized Controlled Study Comparing the Impact of Prophylactic Versus Deferred Lamivudine on the Delivery of Cytotoxic Chemotherapy in Hepatitis B Surface-antigen Positive Patients With Malignant Solid Tumor
Hospital Authority, Hong Kong1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2004年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- incidence of chemotherapy interruptions
研究概览
简要总结
Patients with non-lymphoma and non-leukaemia cancer who are also hepatitis B carriers will have a risk of hepatitis B reactivation during chemotherapy. Lamivudine can be used effectively to control hepatitis upon reactivation during chemotherapy and the chemotherapy may not need to be interrupted. The study aims to investigate whether adding the anti-viral drug Lamivudine at the start of chemotherapy for all patients, rather than at the time of hepatitis reactivation for those with reactivation, will help to improve the delivery of chemotherapy in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with histology-proven malignant solid tumor other than malignant lymphoma
- •Patients with age between 18 and 75
- •Patients with Karnofsky performance score (KPS) of at least 60
- •Patients planned for at least 4 cycles of intensive cytotoxic chemotherapy (either as part of curative therapy or as palliative therapy), except for those receiving single agent cisplatin chemotherapy alone concurrently with radiation for radiosensitization
- •Patients with at least 6 months' life expectany from date of recruitment
- •Patients with normal liver function tests including alanine aminpotransferase (ALT), alkaline phosphatase (ALP), gamma glutamyl-transpeptidase (GGT), and bilirubin
- •Patients with no known history of radiological &/or histological diagnosis of chronic active hepatitis or cirrhosis of any cuase, or history of prior hepatitis B reactivation, or prior chronic therapy for HBV within 6 months
- •Patients with no evidence of autoimmune hepatitis, hepatitis C or delta virus infection, HIV infection or radiological evidence of liver metastasis
- •Patients with negative pregnancy test for female gender of child-bearing age
排除标准
- •Patients with age < 18 and > 75
- •Patients with Karnofsky performance score (KPS) of < 60
- •Patients planned for single agent cisplatin chemotherapy alone concurrently with radiation for radiosensitization
- •Patients with < 6 months' life expectancy from date of recruitment
- •Patients with abnormal liver function tests including alanine aminotransferase (ALT), alkaline phosphatase (ALP), gamma glutamyl- transpeptidase (GGT), and bilirubin
- •Patients with known history or radiological and/or histological diagnosis of chronic active hepatitis or cirrhosis of any cause, or history of prior hepatitis B reactivation, or prior chronic therapy for HBV within 6 months
- •Patients with autoimmune hepatitis, hepatitis C or delta virus infection, HIV infection or radiological evidence of liver metastasis
- •pregnant female patients
结局指标
主要结局
incidence of chemotherapy interruptions
时间窗: during chemotherapy of the study period
次要结局
- incidence of and survival free from hepatitis B reactivation(during and after chemotherapy of the study period)
- HBeAg positive seroconversion and YMDD mutant development rates(during study period after chemotherapy)
- chemotherapy dose intensity reduction due to hepatitis B reactivation(during chemotherapy of the study period)
研究者
研究点 (1)
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