A Multi-center, Open, Dose Exploration and Dose Expansion Phase I/II Clinical Study of Toripalimab（JS001） Combined With Donafenib in Patients With Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Dose limiting toxicity (DLT)
研究概览
简要总结
This study is an open, multi-center phase I/II clinical study.
详细描述
It will explore the tolerability (phase I) and effectiveness (phase II) of the Donafenib tosilate tablets combined with Toripalimab injection in patients with advanced HCC. The study is conducted in two phases, the first phase is the dose exploration phase (phase I), and the second phase is the dose expansion phase (phase II).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with locally advanced or metastatic HCC who are not suitable for surgical resection, who are clinically diagnosed or confirmed by histopathology and/or cytology according to the "Standards for the Diagnosis and Treatment of Primary Liver Cancer" (2017);
- •At least one measurable lesion (according to RECIST v1.1);
- •ECOG performance status score of 0 or 1;
- •Life expectancy ≥ 12 weeks；
- •Have not received systemic therapy (systemic chemotherapy and/or molecular targeted therapy).If the patient has received adjuvant chemotherapy after local treatment, the chemotherapy needs to be over for more than 12 months, and disease progression or metastasis occurs；
- •Fully understand this research and voluntarily sign the ICF。
排除标准
- •Patients with diffuse liver cancer, hepatic encephalopathy that is difficult to control, and liver cancer patients whose lesion size accounts for 70% or more of the entire liver.
- •Patients with intrahepatic cholangiocarcinoma (ICC) or HCC-ICC mixed type；
- •Tumor invades inferior vena cava VP4.
研究组 & 干预措施
JS001+Donafenib
Donafenib 100mg QD/100 mg BID/200 mg BID orally + JS001 240mg Q3W iv
干预措施: Donafenib Tosilate Tablets (Drug)
JS001+Donafenib
Donafenib 100mg QD/100 mg BID/200 mg BID orally + JS001 240mg Q3W iv
干预措施: Toripalimab Injection (Drug)
结局指标
主要结局
Dose limiting toxicity (DLT)
时间窗: 28 days after the first dose of JS001 and Donafenib
Severe toxicity that may be related to JS001 or donafenib during dose escalation of phase I clinical trial
Objective response rate（ORR） as determined by the Invertigator using RECIST V1.1
时间窗: From the time of initial administration until intolerant toxicity, disease progression, withdrawal of ICF, loss of follow-up, death or early study termination occurs (whichever occurs first),assessed up to 18 months
The ratio of patients who are evaluated as CR or PR
次要结局
- Overall survival (OS)(From the time of initial administration until intolerant toxicity, disease progression, withdrawal of ICF, loss of follow-up, death or early study termination occurs (whichever occurs first),assessed up to 18 months)
- Progression free survival (PFS)(From the time of initial administration until intolerant toxicity, disease progression, withdrawal of ICF, loss of follow-up, death or early study termination occurs (whichever occurs first),assessed up to 18 months)
- Anti-JS001 antibody(From the time of initial administration until intolerant toxicity, disease progression, withdrawal of ICF, loss of follow-up, death or early study termination occurs (whichever occurs first),assessed up to 18 months)