A Randomized Controlled Trial of the Efficacy of Hepatectomy or TILA-TACE in Patients With Resectable Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- disease-progression-free period
研究概览
简要总结
Hepatocellular carcinoma (HCC) is one of the most common cancers in the world with major occurrences in eastern Asian countries such as China. HCC is the third leading cause of cancer-related deaths in the world. There are multiple treatment options for liver cancer including surgery, transcatheter arterial chemoembolization (TACE), liver transplantation, absolute ethanol injection, radiation therapy, and biological therapy. Surgery is the primary radical treatment measure for HCC, but its indication is narrow and is only suitable for certain group of patients. Another common treatment for liver cancer, TACE, can not only block tumor blood supply, control tumor growth, or even cause necrosis and result in tumor shrinkage, it can also deliver target chemotherapy drugs to the tumor tissue. However, there are still some controversies on the efficacy of TACE treatment. Therefore in this study, we will conduct a randomized comparison study of the efficacy of surgical resection and TILA-TACE treatment.
详细描述
The Barcelona Clinic Liver Cancer staging system (BCLC) is one of the more recognized staging criteria and has been recommended by the European Association for the Study of Liver and the American Association for the Study of Liver Diseases. BCLC staging is based on patients' general condition, tumor condition, and liver function to identify the best treatment option and predict prognosis using evidence-based medicine. Surgical excision is recommended for BCLC stage 0, liver transplantation or radiofrequency ablation is recommended for BCLC stage A, and TACE treatment is recommended for BCLC stage B.
However, there are still some controversies on the efficacy of TACE treatment. In recent years, development of technologies has led to improved methods including targeting-intratumoral-lactic-acidosis TACE (TILA-TACE). Early clinical practice has confirmed that compared with TACE, TILA-TACE has a relatively high response rate and efficiency. In clinical practice, the current standard treatments for patients with surgically resectable HCC are controversial and there is no recommendation in the guidelines.
This study is designed to evaluate and compare the therapeutic efficacies of surgical resection and TILA-TACE treatment in patients with resectable HCC.
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)
盲法说明
Cases will be randomized by computer into the groups
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
- •Ages 18-75 with no gender, ethnicity, religion, or geographical restrictions.
- •Diagnosed HCC patient.
- •The following criteria will be used for the evaluation of tumor resectability and adequate remaining liver volume: ≥ 30% remaining liver volume/total liver volume for non-hepatitis patients; ≥ 40% remaining liver volume/total liver volume for hepatitis patients.
- •Imaging examination with no cancer embolus above the secondary branch of the portal vein.
- •New lesions found five years after liver cancer treatment.
- •Child-Pugh A or B grade liver function.
- •No concurrent malignancies in other systems.
- •Informed subjects who fully understand and willingly cooperate with the test program with signed relevant documents.
排除标准
- •Suffer from other malignancies.
- •Have received any other liver cancer treatments.
- •Pathological diagnosis as non-HCC.
- •Experience large blood vessel invasion, distant metastases, or unresectable liver cancer.
- •One or more organ failures.
- •Child-Pugh C grade liver function.
- •Incomplete surgical resection or TILA-TACE.
研究组 & 干预措施
Surgery group
We will completely resection of the visible tumor and made the resection margin negative. We will use regular/irregular resection of the liver tumor tissue, hemihepatectomy or extended hepatectomy.
TILA-TACE group
After femoral artery catheterization, 5-Fr angiography catheters will be used for complete radiography of the celiac artery, the hepatic artery proper, left and right hepatic arteries and their branches, and 2.8-Fr micro-catheters will be used for complete radiography of the tumor's nutrient arteries. Lipiodol-epirubicin emulsions and 5% sodium bicarbonate injection solutions will be used for perfusion of chemotherapy drugs. Different sizes of embolic microspheres will be used alternatively for chemoembolization.
干预措施: TILA-TACE (Procedure)
结局指标
主要结局
disease-progression-free period
时间窗: This will be the time period from the beginning of treatment to the time that disease progression has been observed (up to 120 months).
This will be the time period from the beginning of treatment to the time that disease progression has been observed.
次要结局
- overall survival period(from the beginning of the treatment, until the death of the patient or the end of the study period (up to 100 months).)