A Prospective Clinical Trial of TACE Combined With Methylcantharidimide Tablets in the Treatment of Large and Unresectable Hepatocellular Carcinoma
试验速览
- 阶段
- 4 期
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Disease control rate (DCR)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of transarterial chemoembolization (TACE) combined with methylcantharidimide tablets in the treatment of patients with large and unresectable hepatocellular carcinoma.
详细描述
Most guidelines recommend transarterial chemoembolization (TACE), as the standard of care for unresectable hepatocellular carcinoma (HCC ) at Barcelona Clinic Liver Cancer (BCLC) stage A-B. While a number of studies demonstrate poor effect of TACE for patients with large hepatocellular carcinoma. The efficacy of TACE on large (≥ 10 cm) stage A-B HCC is far from satisfactory. The median overall survival was only 6.5-9.1 months. Methylcantharidimide is a single molecule drug used for the treatment of primary liver cancer.
Thus, the investigators carried out this prospective trial to demonstrate the efficacy and safety of TACE combined with methylcantharidimide tablets in patients with large and unresectable hepatocellular carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 range from 18-75 years;
- •The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL);
- •Simultaneously staged as BCLC A or BCLC B based on Barcelona Clinic Liver Cancer staging system;
- •Patients must have at least one tumor lesion that can be accurately measured;
- •Solitary tumor with diameter ≥10cm, or multiple tumors, diameter of the largest was more than 7cm;
- •Diagnosed as unresectable with consensus by the panel of liver surgery experts,
- •Re commanded treated by TACE with consensus by the panel of liver multi-disciplinary treatment (MDT);
- •No past history of TACE, chemotherapy or molecule-targeted treatment;
- •No Cirrhosis or cirrhotic status of Child-Pugh class A only;
- •No liver protection therapy in 2 weeks before enrolled, and meet the following laboratory parameters:(a) Platelet count ≥ 75,000/μL; (b)Hemoglobin ≥ 8.5 g/dL;(c) Total bilirubin ≤ 30mmol/L;(d) Serum albumin ≥ 32 g/L;(e) Glutamic pyruvic transaminase (ALT) and glutamic oxalacetic transaminase (AST) ≤ 6 x upper limit of normal;(f) Serum creatinine≤ 1.5 x upper limit of normal;(g) international normalized ratio（INR）> 2.3 or prothrombin time (PT)/activated partial thromboplastin time (APTT) within normal limits; (h) Absolute neutrophil count (ANC) >1,500/mm3;
- •Ability to understand the protocol and to agree to sign a written informed consent document.
排除标准
- •Factors that affect oral administration, such as dysphagia, chronic diarrhea and intestinal obstruction;
- •Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry;
- •Known of serious heart disease which can nor endure the treatment such as cardiac ventricular arrhythmias requiring anti-arrhythmic therapy;
- •Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy;
- •Known history of HIV;
- •History of organ allograft;
- •Known or suspected allergy to the investigational agents or any agent given in association with this trial;
- •Evidence of bleeding diathesis;
- •Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug;
- •Serious non-healing wound, ulcer, or bone fracture;
- •Known central nervous system tumors including metastatic brain disease;
- •Poor compliance that can not comply with the course of treatment and follow up;
- •Factors that the researchers consider it not appropriate to be included
研究组 & 干预措施
TACE plus methylcantharidimide tablets
Methylcantharidimide tablets( 75mg po tid) is administered before first TACE 3 days and taken continuously after TACE treatment. Every 6 weeks is a cycle.
干预措施: methylcantharidimide tablets (Drug)
结局指标
主要结局
Disease control rate (DCR)
时间窗: 18 months
DCR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), or stable disease (SD). CR was defined as disappearance of any intratumoral arterial enhancement in all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of viable (enhancement of arterial phase) target lesions taking as reference the baseline sum of the diameters of target lesions. SD was when a case does not qualify for either PR or progressive disease (PD) and was new non-target lesions. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions.
次要结局
- Time to progression (TTP)(18 months)
- Overall Survival (OS)(18 months)
- clinical symptoms(18 months)
- Health Related Quality of Life (HRQoL)(18 months)
- Adverse Events(18 months)
研究者
Lei Chen
vice president of hospital
Suzhou Municipal Hospital