Effect of Direct Acting Antiviral Agents on Behavior of Hepatocellular Carcinoma and Overall Survival in Patients With Chronic Hepatitis C
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Behavior of hepatocellular carcinoma
研究概览
简要总结
Investigators aim to study the effect of direct acting antiviral agents (DAAs) on behavior of hepatocellular carcinoma (HCC) and overall survival in patients with chronic hepatitis C (CHC).
详细描述
Introduction:
Chronic hepatitis C (HCV) infection can be complicated with liver cirrhosis and subsequently hepatocellular carcinoma (HCC). HCC develops at an annual rate of 1% to 4%, although higher rates up to 7% have been reported in Japan. Recently; Reig et al; noticed that there was an unexpected high rate of early tumor recurrence in patients with HCV-related HCC undergoing interferon-free therapy (1). After this report; many publications have discussed the issue of HCC development and recurrence in HCV patients treated with interferon free regimens. Results of these trials are controversial with no definite conclusion till today. There is an unmet need for further study the effect of interferon free regimens on development of de novo HCC, recurrence of HCC and behavior of HCC in chronic HCV patients.
Aim of the study:
Investigators aim to study the effect of direct acting antiviral agents (DAAs) on behavior of hepatocellular carcinoma (HCC) and overall survival in patients with chronic hepatitis C (CHC).
Materials & methods:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Patients with HCV related Hepatocellular carcinoma (HCC); all patients with confirmed diagnosis of HCC according to EASL-EORTC guidelines who attend HCC outpatient clinics in the study centers will be enrolled after signing informed consent. Patients will be then assigned into two main comparison groups:
- •Group I: HCC patients who received DAAs for chronic HCV previously (either responders or not)
- •Group II: HCC patients who are naive to DAAs.
排除标准
- •Patients who refuse to be enrolled in the study.
- •Patients with hepatitis B virus or any other causes of cirrhosis.
- •Other prior malignancy without complete remission in the last five years, with the exception of adequately treated basal cell carcinoma or in situ cervical cancer; in case of other prior malignancy, the diagnosis of HCC has to be histologically proven.
- •HCC developed on transplanted liver.
结局指标
主要结局
Behavior of hepatocellular carcinoma
时间窗: 6 months - 3 years
Early recurrence, or rapid progression
Overall survival (OS)
时间窗: 6 months - 3 years
he length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.
次要结局
- Progression-free survival (PFS)(6 months - 3 years)
研究者
Mohamed Alboraie
Principal Investigator
Al-Azhar University