Gecacitinib Combined With Donafenib and PD-1 Inhibitor as Second-Line Therapy for Unresectable Hepatocellular Carcinoma Failed in Immunotherapy, A Phase II Prospective Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Gecacitinib Combined With Donafenib and PD-1 Inhibitor as Immune Rechallenge Therapy for Unresectable Hepatocellular Carcinoma
详细描述
Jak inhibitors have already demonstrated the ability to reverse T-cell exhaustion in the treatment of Hodgkin lymphoma. Gecacitinib is a Jak inhibitor that has been approved for the treatment of bone marrow fibrosis. This study was designed to evaluate the safety and efficacy of Gecacitinib Combined With Donafenib and PD-1 Inhibitor as Immune Rechallenge Therapy for Unresectable Hepatocellular Carcinoma . Total 35 subjects will be recruited in this study, ORR will be will be used as primary outcome measures, OS, PFS, DCR and safety will be the secondary endpoints.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age and gender: >18 years old and≤75 years old, both men and women.
- •All subjects must have Hepatocellular Carcinoma confirmed by pathological or clinical diagnosis.
- •Patients with viable and measurable target lesion per RECIST 1.
- •Patients with unresectable hepatocellular carcinoma (uHCC) who experienced disease progression after first-line therapy containing immune checkpoint inhibitors.
- •Patients who are expected to live more than 3 months.
- •9.ECOG PS 0-
- •10.Child-Pugh ≤7.
排除标准
- •Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma confirmed by histology or cytology.
- •History of malignant tumor, excluding the following cases:
- •Malignant tumor that was curatively treated more than 5 years prior to study entry and has not recurred since then;
- •Successful radical resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder carcinoma, preinvasive cervix carcinoma, and other preinvasive cancers.
- •Diffuse tumor lesion.
- •Preexisting or history of hepatic encephalopathy, hepatorenal syndrome or liver transplantation.
- •Clinically uncontrolled ascites or pleural effusion.
- •Received treatment with a JAK inhibitor previously .
- •Clinically severe gastrointestinal bleeding within 6 months of the start of treatment or any life-threatening bleeding events within 3 months of the start of treatment.
研究组 & 干预措施
study arm
The participants in this arm will be treated with combination therapy of Gecacitinib（100mg,Bid,po）, Donafenib (200mg,Bid,po), and PD-1(Q3W,iv).
干预措施: Gecacitinib Combined With Donafenib and PD-1 Inhibitor (Drug)
结局指标
主要结局
ORR
时间窗: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
Evaluation of tumor burden based on mRECIST criteria
次要结局
- DCR(From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years)
- OS(From date of enrollment until the date of death from any cause, assessed up to 3 years)
- PFS(From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years)
- Incidence of treatment-related adverse events (TRAE)(From date of enrollment until the date of 30 days after the last treatment according to the protocol, assessed up to 3 years)
研究者
Wei Zhang
Professor
Tianjin Medical University Cancer Institute and Hospital