RECURRENCE RATE OF HEPATOCELLULAR CARCINOMA AFTER TREATMENT OF CHRONIC HEPATITIS C PATIENTS WITH DIRECT ACTING ANTIVIRALS: RANDOMIZED CONTROLLED PHASE 3 TRIAL (CAUTIOUS TRIAL)
试验速览
- 阶段
- 3 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Recurrence rate
研究概览
简要总结
- Unexpected results were published in 2016 showed increased aggressiveness and rates of HCC recurrence after curative treatment of HCC in HCV patients treated by DAAs achieving SVR. On the other hand, the retrospective analysis of ANRS study, did not observe an increased risk of HCC recurrence after DAAs treatment in patients who underwent curative HCC treatment.
- Assess the recurrence rate of HCC in HCV infected patients with prior history of treated HCC who achieved rCR with and without administration of DAAs and assess the effect of its timing.
详细描述
Hepatocellular carcinoma (HCC) is the most common primary cancer of the liver, represents more than 90% of primary liver cancers, and is one of the leading cause of cancer-related death worldwide, therefore, it is a major global health problem.
In 2017, it is estimated that 40,710 people in the united states will be diagnosed with liver cancer and intrahepatic duct cancer; 29,200 males and 11,510 females and approximately 28,920 deaths. Incidence rates of HCC are 3 times higher in males than in females.
In Egypt, the estimated number of liver cancer is increasing as it was 29,975 in 2015 and will be 35,320 in 2020, 41,513 in 2025 and 85,471 in 2050. Liver cancer is the most frequent cancer in Egypt as it represents about 24% of all cancers in Egypt.
Cirrhosis is an important risk factor for HCC, and may be caused by chronic viral hepatitis, alcohol, inherited metabolic diseases such as hemochromatosis or alpha-1-antitrypsin deficiency, and non-alcoholic fatty liver disease. All causes of cirrhosis may be complicated by carcinogenesis, but the risk is higher in patients with hepatitis infection. Overall, one-third of cirrhotic patients will develop HCC during their lifetime.
Worldwide, approximately 54% of all cases of HCC are associated with hepatitis B virus (HBV) infection, while 31% are due to hepatitis c virus (HCV) infection, while only 15% are associated with other causes.
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
- 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
- •Age: more than or equal to 18 years old.
- •Confirmed HCV viremia by PCR.
- •CHILD Pugh "A".
- •HCC diagnosed by criteria according to AASLD guidelines.
- •HCC patients should have been treated prior to randomization by resection, or ablation and achieving rCR.
排除标准
- •Patients below 18 old.
- •Patients with advanced liver condition.
- •Patients known HBV or HIV infection.
- •Prior history of liver transplantation.
- •HCC treatment but without rCR before randomization
- •Pregnancy and lactation.
- •Patients with other malignancies other than HCC.
研究组 & 干预措施
Administration of DAA-based treatment (Arm 1)
Arm 1 will be divided into 2 groups by randomization according to a 1:1 ratio into:
Group A: Administration of DAA-based treatment after 3 months of complete remission of HCC.
Group B: Administration of DAA-based treatment after 6 months of complete remission of HCC.
干预措施: Administration of DAA-based treatment (Drug)
Control arm (Arm 2)
Not receiving DAAs after complete remission of HCC and to be kept on follow-up
干预措施: Administration of DAA-based treatment (Drug)
结局指标
主要结局
Recurrence rate
时间窗: Follow up will be done from baseline for up to 24 months for detection of sustained HCC treatment,tumoral progression or denovo occurrence
To compare the Recurrence Rate of HCC in the two main randomized arms (administration of DAAs "arm 1" and control arm "arm 2")
次要结局
- effect of timing of administration of DAAs after achieving rCR as regard recurrence rate(Follow up will be done from baseline for up to 24 months)
- Identifications of predictive factors of HCC recurrence(Follow up will be done from baseline for up to 24 months)
研究者
Fatma Sayed
Ph.D Candidate
Ain Shams University