An Open, Randomized Controlled Clinical Trial to Compare the Prophylactic Use or Preemptive Use of an Anti-viral Drug Entecavir in Patients With Colorectal Cancer Who Are Inactive Hepatitis B Carriers
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence of hepatitis B virus associated hepatitis
研究概览
简要总结
There has been no report on whether the patients with colorectal cancer who are also inactive Hepatitis B Carriers should receive Prophylactic Use or preemptive Use of an Anti-viral Drug Entecavir. This open, randomized controlled clinical trial aims to compare the impact of the prophylactic use or preemptive use of an anti-viral drug Entecavir on the outcomes of patients with colorectal cancer who are also inactive hepatitis B carriers during chemotherapy and the subsequent follow-ups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients with age between 18 and 75
- •Patient with histology-proven colorectal adenocarcinoma.
- •Patients with Eastern Cooperative Oncology Group performance status (ECOG) of 0-1
- •Patients planned for at least 4 cycles of cytotoxic chemotherapy (either as part of curative therapy or as palliative therapy)
- •Patients with at least 6 months' life expectancy from date of recruitment
- •Patients with positive Hepatitis B Surface-antigen (HBsAg)
- •Patients with normal liver function tests including alanine aminotransferase (ALT), aspartate aminotransferase alkaline (AST), phosphatase (ALP), gamma glutamyl-transpeptidase (GGT), and bilirubin
- •Patients with negative HBV-DNA
- •Patients with no known history of radiological &/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 no evidence of autoimmune hepatitis, hepatitis C or D virus infection, HIV infection or radiological evidence of liver metastasis
- •adequate bone marrow, hepatic, and renal function within 14 days before recruitment
- •patients who sign the informed consent
- •Patients with good compliance during chemotherapy and follow-ups
排除标准
- •Patients planned for radiation or radionuclide therapy
- •Pregnant female patients
- •Patients with a history of psychiatric drugs abuse and can't quit or with a mental disorder
- •Patients with immunodeficiency, other congenital or acquired immunodeficiency, or transplantation history
- •According to the investigators' judgment, patients with concomitant disease that seriously harms patients' safety or the completion of study.
研究组 & 干预措施
Prophylactic Entecavir
Entecavir is prophylactically used from the time of chemotherapy initiation at the dose of 0.5 mg p.o daily
干预措施: Entecavir (Drug)
Preemptive Entecavir
Entecavir is preemptively used from the time that hepatitis B virus DNA copies are more than 100 IU/ml at the dose of 0.5 mg p.o daily
干预措施: Entecavir (Drug)
结局指标
主要结局
Incidence of hepatitis B virus associated hepatitis
时间窗: through study completion, an average of 1 year
Hepatitis is defined as a 3-fold or greater increase in the serum ALT level that exceeded the reference range (\>58U/L) or an absolute increase in the level of ALT of greater than 100 U/L compared with the baseline level
次要结局
- Incidence of hepatitis B virus reactivation(through study completion, an average of 1 year)
- Interruption of chemotherapy due to hepatitis(through study completion, an average of 1 year)
研究者
Ruihua Xu
Dr
Sun Yat-sen University