A Randomized Control Clinical Trial Between Precise Hepatectomy and Combined Interventional Treatment on Hepatocellular Carcinoma (HCC) With Cirrhotic Portal Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
There is no consensus about the optimal treatment of hepatocellular carcinoma (HCC) with cirrhotic portal hypertension, While this group of patients are classified as hepatectomy contraindication according to guidelines from National Comprehensive Cancer Network (NCCN) and American Association for the Study of Liver Diseases (AASLD). With improvement of surgical technique, preoperative evaluation, and perioperative management,especially the Precise Hepatectomy Technique, more and more studies confirmed the safety of surgical intervention to hepatocellular carcinoma (HCC) patients with cirrhotic portal hypertension.However, most of the previous studies were either retrospective or with small samples.
The investigators project is a prospective randomized controlled trial, planning to compare the safety, efficacy and quality of life between precise hepatectomy and combined interventional treatment on hepatocellular carcinoma (HCC) with cirrhotic portal hypertension, to make a further understanding of optimal strategy.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of hepatocellular carcinoma patients, in accordance with HCC Professional Committee of the Chinese Anti-Cancer Association 2001 "Clinical Diagnosis of Primary Liver Cancer and Staging Criteria"
- •solitary tumor ≤5cm, or three or fewer lesions none ≤3cm，As Milan criteria
- •History of hepatitis B or HBsAg positive
- •Cirrhosis and portal hypertension
- •No treatment on liver cancer before
- •KPS score ≥ 70
- •The age of 18 to 65 years
- •Child-Pugh A or B (Class B, scoring no more than 7 points)
- •Baseline laboratory test comply with the following criteria:
- •White blood cell ≥ 1.0×109/L
- •Platelet ≥ 25×109/L
- •Hemoglobin ≥ 80g/L
- •Serum ALT,AST ≤ 3×upper limit of normal (ULN)
- •Serum creatinine ≤ 1.5 × ULN
- •INR<1.5, or prothrombin time <ULN +4 sec
- •Albumin ≥30g/L
- •Total bilirubin ≤34mmol/L
- •Informed consent with signature and time
- •Good patient compliance
- •The surgical group patients received radical hepatectomy. Radical surgery is defined as: complete resection of visible tumor, R0 resection margins, and also including:
- •The number of tumors is less than 3
- •No tumor thrombus found in major branch of the portal veins, hepatics, inferior vena cava or bile duct
- •No hepatic hilar lymph node metastasis
- •No extrahepatic metastasis
排除标准
- •extrahepatic metastasis; With metastasis in major branch of portal vein, hepatic vein
- •History of hepatitis C or HCV-Ab positive
- •Pugh Child-Pugh C, or with massive ascites or had a history of hepatic encephalopathy, or Upper digestive tract bleeding
- •Poor physical condition or cachexia
- •During the past 12 months just before the study, there had been any of the following: myocardial infarction, severe/unstable angina, coronary artery bypass graft surgery, congestive heart failure, cerebrovascular accident (including transient ischemic attack), pulmonary embolism; arrhythmia according to the NCI-CTCAE ≥ grade 2, QTc interval extension (male> 450 ms, female> 470 ms);
- •Renal insufficiency, need peritoneal dialysis or hemodialysis
- •Serious dysfunction of other organs
- •History of second primary malignant tumors
- •Known or new evidence of brain or leptomeningeal disease
- •Hemophilia or bleeding tendency, and are taking therapeutic doses of coumarin derivative anticoagulant therapy drugs
- •Pregnant or lactation, all female patients with childbearing potential must have a pregnancy test (serum or urine) within 7 days after enrollment,and the result is negative
- •History of organ transplantation
- •Known HIV infection
- •With any other serious acute and chronic physical or mental disease or abnormal laboratory tests, which are likely to increase risks or interfere with the interpretation of the results, or researchers believe that patients are not suitable for enrollment
研究组 & 干预措施
surgery
Precise hepatectomy
干预措施: Precise hepatectomy (Procedure)
combined intervention
transcatheter hepatic arterial chemoembolization and/or ablation
干预措施: Combined intervention (chemoembolization/ablation) (Other)
结局指标
主要结局
Overall survival
时间窗: 5 years
Overall survival is based on death from any cause, not just the condition being treated, thus it picks up death from side effects of the treatment, and effects on survival after relapse
次要结局
- Time to progress(TTP)(3 years)
- Disease control rate(DCR)(3 years)
- Treatment complication(90 days)
- Quality of life(Qol)(5 years)
研究者
Yunfei Yuan
Prof.
Sun Yat-sen University