NCT02125396Unknown3 期
Adjuvant Radiotherapy Comparing Transarterial Chemoembolization for Curative Hepatocellular Carcinoma: a Randomized Controlled Trials
Guangxi Medical University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年5月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Overall survivals
研究概览
简要总结
Despite advances in our understanding of hepatocellular carcinoma (HCC) and its diagnosis, the prognosis for patients with HCC remains disheartening, due to a high recurrence rate and frequent intrahepatic metastasis. Various therapies for use after hepatic resection have been reported, but they are associated with adverse side effects or they fail to improve overall survival. Nowadays, adjuvant transarterial chemoembolization (TACE) is recommended as the most effective therapy for postoperative HCC. And the indication is patients with risk factors of recurrence. While more and more prospective studies revealed that radiotherapy is effective for advanced HCC. And the side effects of radiotherapy are controlled. Until now, no prospective or retrospective study compared the efficacy of adjuvant TACE and radiotherapy for postoperative 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
- 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
- •Age 18-75 years
- •Diagnosis of HCC was confirmed by histopathological examination of surgical samples in all patients
- •Patients have Child-Pugh A liver function and undergo potentially curative hepatic resection
- •Patients with risk factors for recurrence (tumor size >5 cm, multiple nodules, vascular invasion, absence of tumor capsule, poorly differentiated tumor, and narrow resection margin)
- •No previous treatment of HCC except liver resection
- •No evidence of metastasis to the lymph nodes and/or distant metastases on the basis of preoperative imaging results and perioperative findings
- •No malignancy other than HCC for 5 years prior to the initial HCC treatment
- •No imaging evidence of invasion into the major portal/hepatic vein branches
- •No history of encephalopathy, ascites refractory to diuretics or variceal bleeding
排除标准
- •History of cardiac disease:
- •congestive heart failure > New York Heart Association (NYHA) class 2;
- •active coronary artery disease (myocardial infarction more than 6 months prior to study entry is permitted);
- •cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers, calcium channel blocker or digoxin; or
- •uncontrolled hypertension (failure of diastolic blood pressure to fall below 90 mmHg, despite the use of 3 antihypertensive drugs).
- •Active clinically serious infections ( > grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)
- •Known history of human immunodeficiency virus (HIV) infection
- •Known Central Nervous System tumors including metastatic brain disease
- •Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
- •History of organ allograft
- •Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- •Known or suspected allergy to the investigational agent or any agent given in association with this trial
- •Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
- •Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial.
- •Excluded therapies and medications, previous and concomitant:
- •Prior use of any systemic anti-cancer treatment for HCC, eg. chemotherapy, immunotherapy or hormonal therapy (except that hormonal therapy for supportive care is permitted). Antiviral treatment is allowed, however interferon therapy must be stopped at least 4 weeks prior randomization.
- •Prior use of systemic investigational agents for HCC
- •Autologous bone marrow transplant or stem cell rescue within four months of start of study drug
结局指标
主要结局
Overall survivals
时间窗: 5 years
次要结局
- Recurrence rates(5 years)
研究者
Jian-Hong Zhong
Affiliated Tumor Hospital
Guangxi Medical University
研究点 (1)
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