A Phase I/II, Dose-escalation Study of Lipotecan® Plus Radiotherapy in Locally Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Adverse Event/Serious Adverse Event
研究概览
简要总结
Radiotherapy (R/T) for locally advanced hepatocellular carcinoma (HCC) is often used in patient who is not suitable for transarterial chemoembolization (TACE) and other local therapy, especially in those with portal vein tumor thrombosis (PVTT) caused by tumor cells. Several previous studies have showed that local R/T is tolerable and can induce a substantial tumor response in HCC management. In addition, the safety, toxicity and preliminary efficacy of Lipotecan® (TLC388) has also been proved in patients with terminal malignancy. This study aims to evaluate the safety, tolerability and efficacy of concomitant Lipotecan® and radiotherapy in patients with locally advanced HCC and PVTT.
详细描述
Lipotecan® is a drug product of TLC388 HCl, which is a potent camptothecin analog with cytotoxic activities against a variety of human tumor cell lines and anti-tumor activities in several xenograft models with human tumor cell lines. Structurally, TLC388 HCl is related to other camptothecins, but it has been chemically modified to improve stability and potency, and to minimize toxicities.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Females or males 20-70 years of age (inclusive)
- •Patients with histological confirmed HCC or other conditions
- •Patients with locally advanced HCC and PVTT that is not suitable for other local therapies
- •Other inclusion criteria also apply
排除标准
- •Females who are pregnant/lactating or planning to be pregnant, or patients of childbearing potential who are not using medically recognized method of contraception.
- •Patients with documented extrahepatic metastasis
- •Patients with stage III-IV encephalopathy or tense ascites
- •Patients who have received any local or systemic therapy for HCC within 4 weeks prior to the initiation of study treatment
- •Patients who have received Lipotecan® treatment prior to the initiation of study treatment
- •Other exclusion criteria also apply
研究组 & 干预措施
Lipotecan® (TLC388)
Dosage form: 40mg TLC388 base/vial lyophilized cake Dose: Chemotherapy, i.v. q.w. x 6 doses (dose-escalation)
* The dosage regimen would be escalated gradually until MTD had been found out.
干预措施: Lipotecan® (TLC388) (Drug)
结局指标
主要结局
Adverse Event/Serious Adverse Event
时间窗: week 12
Serious/ Adverse Event
Maximum tolerated dose (MTD)
时间窗: week 12
Maximum tolerated dose
Dose-limiting toxicity (DLT)
时间窗: week 12
Dose-limiting toxicity
PVTT response rate
时间窗: week7
PVTT response rate
次要结局
- Tumor downstaging rate(week7, week12)
- Hepatic tumor response rate (overall tumor response rate)(week7, week12)
- Change from baseline in tumor marker/biomarkers(week4, week7, week12)
- Overall survival (OS)(week7, week12, 1year)
- Time to progression (TTP)(week7, week12, 1 year)
- Progression-free survival (PFS)(week7, week12, 1 year)