Adjuvant α-Interferon Treatment After Resection of Hepatocellular Carcinoma in HCV-Related Cirrhosis: a Randomized Trial on Prevention of Cancer Recurrence
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Recurrence Free Survival
研究概览
简要总结
We conducted a randomized controlled trial of adjuvant interferon (IFN) therapy in patients with hepatitis-C virus (HCV)-related cirrhosis who underwent curative resection of hepatocellular carcinoma (HCC) to investigate whether IFN could reduce or delay the incidence of recurrent tumor (secondary/tertiary prevention of HCC). Patients were randomly assigned to treatment with IFN (3MU thrice/wk /48 weeks) vs. no treatment after curative resection of HCC(control group)
详细描述
Background
Primary liver cancer (hepatocellular carcinoma, HCC) remains a major cancer-related cause of death with an estimated incidence of 1 million cases per year worldwide and particular endemic distribution related to chronic hepatitis carriers. Post-necrotic cirrhosis due to chronic infection by HBV and HCV is the leading background for HCC development with a yearly rate of 3% and a 5-year probability of survival of 20%.
Liver surgery, resection or transplantation, appears the only chance of curative treatment of the tumor, but feasibility is still ranging from 15 to 30% in Western countries at time of diagnosis. Several alternative treatments are available but their potential curative effects are lacking, due to the absence of controlled trials.
Liver resection is claimed to be feasible in order 15-30% of patients with HCC with mortality reported in major centers extremely low (5%). Technical and biological devices developed in the setting of OLT can now support the limited reserve of cirrhotic livers after resection.
Regulated segmentectomy is advisable with removal of the whole portal territory belonging to the tumor. Single nodule tumors (< 5 cm) and compensated cirrhosis (Child class A) are accepted as the best candidates for liver resection that now can be performed with minimal blood loss, and minimal ischemia damage. Intraoperative ultra sound examination is now routinely used as the golden standard for staging and detection of previously undiscovered neoplastic nodules. Hepatic decompensation with ascites development, cholestasis and variceal bleeding within three months from surgery are the main negative prognostic factors for patient survival. Five years survival exceed 50% but tumor recurrences due to cirrhosis persistence could exceed 30% after three years of follow-up. Several attempts to reduce recurrence through antiangiogenetic and antiproliferative agents have been proposed.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCV-RNA positive / HBsAg-negative patients with HCC undergoing potentially curative resection
- •Curative surgery (i.e. no residual tumor intraoperative US and tumor-free margins at pathology)
- •No recurrence 1 month after surgery (CT, NMR, US)
- •Pre-resection treatments allowed (TACE, RFA, PEI)
- •HCV-RNA positive (lower limit of detection: 100 copies/ml) regardless of blood titers or genotype
排除标准
- •HBsAg-positivity
- •Evidence of any active neoplastic site
- •Previous IFN or chemotherapy or treatment of other tumors
- •Severe surgical complication and/or causes of cirrhosis not related to HCV
- •Patient comorbidity (Hb <12 g/dl, HIV infection, autoimmune disease, psychiatric disorder, seizure, severe cardiovascular disease, poorly controlled diabetes, BMI >35)
- •Active alcohol intake (>80 g/day)
结局指标
主要结局
Recurrence Free Survival
次要结局
- Disease Specific Survival
- Overall Patient Survival