A Randomized, Multi-centre, Efficacy Evaluation of PI-88 in Patients With Hepatocellular Carcinoma After Hepatectomy - A Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 172
- 试验地点
- 6
- 主要终点
- Tumour Non-recurrence Rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of PI-88 to inhibit or reduce tumor recurrence in patients with hepatocellular carcinoma following hepatectomy.
详细描述
Although early diagnosis and treatment improve survival, hepatocellular carcinoma (HCC) is rarely cured and recurs frequently after regional therapy or transplantation. Hepatic resection can improve 5-year recurrence-free survival by up to 25%. Micrometastases of HCC have been detected by molecular techniques in 88% of patients at the time of surgery, and probably cause postoperative recurrence. Efforts to reduce the risk of recurrence after a curative resection have been tried, including various regimens of adjuvant and neoadjuvant therapy.
In this study , an anti-angiogenic agent, PI-88, is being used as an adjuvant therapy for HCC patients after curative hepatic resection. The efficacy endpoints, including tumour non-recurrence rate, time to first recurrence and 1-year survival rate are being evaluated. Several risk factors associated with tumour recurrence are also being analysed.
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
- •Patients have voluntarily given written informed consent
- •Age ≥ 18 years but ≤ 75 years
- •Males or females
- •Histological diagnosis of hepatocellular carcinoma
- •Curative hepatectomy within the past 4-6 weeks
- •ECOG performance status of 0 to 2
- •Cardiac functional capacity ≤ to class II (New York Heart Association)
- •Patients with adequate renal, hepatic, and haematopoietic function as defined by:
- •Serum creatinine ≤ 2.0 mg/dL
- •Total bilirubin < 2.5 mg/dL
- •Neutrophil count > 1.5 x 10^9/L
- •ALT < 5 x upper limit of normal (ULN)
- •White blood cell (WBC) count ≥ 3 x 10^9/L
- •Platelet count ≥ 80 x 10^9/L
- •Prothrombin time international normalized ratio (PT-INR) ≤ 1.3 (or PT-INR ≤ 1.4 but PT within normal range)
- •Activated partial thromboplastin time (APTT) < ULN
排除标准
- •Patients with history of allergy and/or hypersensitivity to anticoagulants/thrombolytic agents, especially heparin.
- •Patients with history of immune mediated thrombocytopenia, thrombotic thrombocytopenic purpura, or other platelet disease
- •Patients with previous positive result in a heparin-induced thrombocytopenia (HIT) antibody test.
- •Patients with any tumour metastasis.
- •Patients with uncontrolled infection or serious infection within the past 4 weeks.
- •Patients with myocardial infarction, stroke, or congestive heart failure within the past 3 months.
- •Patients with history of inflammatory bowel disease, any other abnormal bleeding tendency, or patients at risk of bleeding due to open wounds or planned surgery.
- •Patients with acute or chronic gastrointestinal bleeding within the past 1 year.
- •Patients with a history of drug abuse or psychiatric disorder.
- •Patients with known HIV infection or AIDS-related illness.
- •Patients who received other investigational or anti-neoplastic medication within the past 4 weeks.
- •Use of aspirin, aspirin-containing medications, non-steroidal anti-inflammatory drugs (except for COX-2 inhibitors), heparin, low molecular weight heparin, warfarin, anti-platelet drugs, or any other anticoagulant medications 2 weeks prior to or during the study period.
- •Women who are pregnant or breast-feeding.
- •Women of child-bearing potential who are not using an adequate method of contraception.
研究组 & 干预措施
160 mg PI-88/Day
PI-88 160 mg/day SC injection
干预措施: PI-88 (Drug)
250 mg PI-88/Day
PI-88 250 mg/day SC injection
干预措施: PI-88 (Drug)
结局指标
主要结局
Tumour Non-recurrence Rate
时间窗: Week 48
The tumor non-recurrence rate at the end of the 48-week study period
次要结局
- Time to Recurrence(until confirmed tumour recurrence, or for a maximum of 48 weeks)
- Survival Rate(Week 48)