NCT00644020Unknown不适用
A Randomized, Double Blind, Placebo Controled, Multicenter Phase ⅡStudy to Evaluate the Safety and Efficacy of Tyroserleutide for Injection in Hepatocellular Carcinoma(HCC) Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- DFS(disease free survival)
研究概览
简要总结
The investigation is a randomized, double-blind, placebo involved and multi-center clinical trial. All subjects are assigned to 4 groups, including 3mg, 6mg, 12mg per day and placebo group. Each group includes 25 subjects, who have hepatic-cellular carcinoma accompanied with branch vein thrombosis. They receive investigational drug 40 days after resection surgery. Each cycle lasts 4 to 6 days with an interval of 29 days in all 6 cycles.
详细描述
- Patients who have signed the Informed Consent Form and are eligible for the entry criteria will be randomly assigned to either the TYROSERLEUTIDE treatment group or the placebo group. No matter which group the subject is assigned, he/she would receive chemotherapy treatment through the portal vein pump which was transplanted during the carcinoma section surgery 40 days before the randomization.
- Participants will be given either TYROSERLEUTIDE or placebo through intravenous injection with an interval of 29 days, during which the participant will not take any investigational drug or any other anti-tumor treatment as well. On the day just next to the completion of each cycle of research treatment which usually lasts for 3-5 days, the participant will receive medical inspection so as to observe and ensure drug safety.
- Participants will continue to receive investigational drug for 6 cycles until being detected with recurrence or metastasis of tumor or experiencing any serious side effects.
- A CT scan or MRI scan will be performed for each participant to exclude the recurrence or metastasis of tumor and assess the effects of treatment once before the initiation of each new cycle.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Written informed consent
- •Age between 18 and 75 years
- •Hepatocellular Carcinoma accompanied with branch vein thrombosis
- •Carcinoma and bolt resection Integrity, cutting edge no tumor cells by microscopic lens in operation
- •CTA or MRI no Carcinoma and bolt after operation
排除标准
- •hypersensitivity to the composition similarity of investigational drug
- •Concomitance other system primary tumor
- •surface area 1.47m2～1.92m2
- •HBV (-) and HCV(-)
- •Patients who have received resectional surgery for HCC
- •HCC complicating main portal vein cork
- •HCC complicating hepatic vein cork
- •Patients who have received systematicness therapy for HCC
- •Patients who have received immunoregulant 4 weeks before randomization
- •Concurrent participation in another clinical trial involving experimental treatment is excluded 4 weeks before randomization
- •uncontrolled infection, hemorrhage, guts leakage postoperative complications
- •postoperative liver function Child-pugh C
- •no evidence of extra-hepatic metastases postoperative
- •no utility sample for gene chip research
- •no physical examination, laboratory and imageology examination that baseline request
研究组 & 干预措施
Group 1
the Tyroserleutide for injection at the dosage of 3mg/d
干预措施: mitomycin, Fluorouracil (Drug)
Group 2
the Tyroserleutide for injection at the dosage of 6mg/d
干预措施: mitomycin, Fluorouracil (Drug)
Group 3
the Tyroserleutide for injection at the dosage of 12mg/d
干预措施: mitomycin, Fluorouracil (Drug)
Group 4
the placebo group
干预措施: mitomycin, Fluorouracil (Drug)
结局指标
主要结局
DFS(disease free survival)
时间窗: six month
次要结局
- 1.OS （Overall Survival） 2.QOL (quality of life)(six month)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
A Study of Oryz-Aspergillus Enzyme and Pancreatin Tablet in Patients With Cirrhosis and MalnutritionCirrhosisNCT04057326Shenzhen Kangzhe Pharmaceutical Co., Ltd.132
Unknown
4 期
Efficacy and Safety of Yuxuebi Tablet in Treating Night Pain of Ankylosing Spondylitis (AS).Ankylosing SpondylitisNCT04934059China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.60
已完成
2 期
Evaluate the Efficacy and Safety of D-2570 in Participants With Moderate-to-Severe Plaque PsoriasisPlaque PsoriasisNCT06278350InventisBio Co., Ltd161
Unknown
4 期
A Clinical Study to Evaluate the Efficacy and Safety of Hemocoagulase InjectionHemoptysisNCT03270735Lee's Pharmaceutical Limited100
招募中
1 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Uterine Blood Mesenchymal Stem Cells Injection for the Treatment of Severe Pneumonia Caused by VirusesSevere Viral Pneumonia(Not Include COVID-19)NCT06693362Ruijin Hospital60