Dose Escalation Study Of Donafenib and Toripalimab Combined With TACE in Patients With Unresectable Hepatocellular Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Dose limiting toxicity(DLT)
研究概览
简要总结
This study is the single-center, open-label phase I clinical trial to evaluate tolerability, safety and efficacy of Donafenib and JS001 in combination with TCAE in patients with Unresectable Hepatocellular Carcinoma.
详细描述
The phase I clinical trial is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of Donafenib in this regimen, and select an acceptable safe dose for the phase II clinical trial(RP2D).
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 18-75 (inclusive), male or female;
- •Diagnosis of Unresectable Hepatocellular Carcinoma confirmed clinically or histologically or cytologically according to the "Guidelines for diagnosis and treatment of primary liver cancer" (2019 Edition);
- •At least one measurable lesion (according to RECIST v1.1)
- •ECOG performance status score of 0 -1;
- •Life expectancy ≥ 12 weeks;
- •Fully understand this research and voluntarily sign the ICF.
排除标准
- •Diffuse liver cancer；
- •Refractory hepatic encephalopathy, refractory ascites, or hepatorenal syndrome；
- •Pregnancy or lactation；
- •Patients with extrahepatic diffusion；
- •Spontaneous tumor rupture；
- •Expected non-compliance.
研究组 & 干预措施
Donafenib/JS001/TACE
Donafenib and JS001 Combined With TACE
干预措施: Donafenib Tosilate Tablets (Drug)
Donafenib/JS001/TACE
Donafenib and JS001 Combined With TACE
干预措施: Toripalimab Injection (Biological)
结局指标
主要结局
Dose limiting toxicity(DLT)
时间窗: 21 days after the first dose of JS001 and Donafenib, assessed up to 2 years
Dose limiting toxicity (DLT) is referred to grade 3 non-hematological toxicity or grade 4 hematological toxicity.
次要结局
- Duration of response (DOR)(From the date of first documented response (RECIST 1.1.) until the first date of documented progression or death in the absence of disease progression, assessed up to 2 years.)
- Overall survival (OS)(From the date of randomization until death due to any cause, assessed up to 2 years.)
- Progression free survival (PFS)(From date of randomization until the date of objective disease progression or death, assessed up to 2 years.)