A Prospective Multicenter Non-randomized Controlled Study of Palliative Treatments for Patients With Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
The standard treatment choice for advanced hepatocellular carcinoma (HCC) is sorafenib, and its efficacy is limited. More active treatments were performed in patients with advanced HCC in China, which include radical hepatectomy or TACE. The study is to investigate whether the active treatment will profit survival of patients, and to evaluate the safety.
详细描述
This is a prospective non-randomized controlled study. Patients with advanced hepatocellular carcinoma (BCLC C stage) who underwent palliative resection or TACE followed with Sorafenib or treated by sorafenib alone will be included. The patients will be divided to group A (palliative resection plus sorafenib), group B (palliative TACE plus sorafenib), and group C (sorafenib alone). The sample size will be about 200 cases altogether.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Male or female patients > 18 years of age.
- •Diagnosed to have advanced HCC (BCLC C stage).
- •Patients who have a life expectancy of at least 12 weeks.
- •Patients whose primary tumor can be resected.
- •Definition of resectable in this study:
- •Tumor number <=
- •If number of tumors >= 3, then all tumors were located in the same lobe.
- •Without tumor invasion of the main trunk of the portal vein, or hepatic duct, or caval vein.
- •Hepatocellular carcinoma with histological diagnose or clinical diagnose according to AASLD.
- •No major post-operative complication.
- •Patients who have an ECOG PS of 0, or
- •Cirrhotic status of Child-Pugh class A only.
- •The following laboratory parameters:
- •Platelet count > 60 x 109/L Hemoglobin > 8.5 g/dL Albumin > 3.5 g/dL Total bilirubin < 25μmol/L Alanine transaminase (ALT) and AST < 2.5 x upper limit of normal Serum creatinine <1.5 x the upper limit of normal Prothrombin time (PT)<3 seconds above control.
- •Patients who give written informed consent.
排除标准
- •Previous or concurrent cancer that is distinct in primary site or histology from HCC.
- •History of cardiac disease.
- •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.
- •Known or suspected allergy to the investigational agent or any agent given in association with this trial.
- •Pregnant or breast-feeding patients.
- •Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study.
- •Excluded therapies and medications, previous and concomitant: Systemic chemotherapy and target drug other than sorafenib. Antiviral treatment is allowed.
- •Radiotherapy except for which done for bone metastases palliatively.
研究组 & 干预措施
A, surgery
The patients in this group will receive palliative resection of HCC, then take sorafenib as remain therapy.
干预措施: hepatic resection (Procedure)
B, TACE
Patients in group B will receive transcatheter hepatic arterial chemoembolization, then take sorafenib as remain therapy.
干预措施: transcatheter hepatic arterial chemoembolization (Procedure)
C, sorafenib
Patients in group C will receive monotherapy of sorafenib.
干预措施: sorafenib (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: anticipate 6-12 months
defined as the time from the first treatment to death
次要结局
- AEs and SAEs(anticipate 6-12 months)
- Progression Free Survival (PFS)(anticipate 3-6 months)
- cost of treatments(3 months in average)
研究者
XU li
Department of Hepatobiliary Surgery, Cancer Center
Sun Yat-sen University