Nimotuzumab Combined With Immune Checkpoint Inhibitors for the Treatment of Advanced Liver Cancer After First Line Treatment Failure ，a Prospective， Open Label，Single Arm，Phase II Trail
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- ORR（Objtective reseponse rate）
研究概览
简要总结
This is a phase II, open-label, single-arm clinical study of nimotuzumab in combination with immune checkpoint inhibitors in patients with advanced liver cancer who have failed first-line therapy
详细描述
This study is a prospective, single-arm study, and plans to include 30 patients with hepatocellular carcinoma who do not respond to first-line therapy with a protoPD-1 (or PD-L1) inhibitor in combination with nimotuzumab in the posterior line, and receive nimotuzumab 400mg, D1, QW in combination with PD-1 (or PD-L1) inhibitor in the later line of treatment until disease progression and intolerable toxicity
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
- 17 Years 至 79 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with histologically or cytologically confirmed advanced hepatocellular carcinoma (HCC), or The clinical diagnosis meets the American Association of Liver Diseases (AASLD) diagnostic criteria for hepatocellular carcinoma；
- •Prior experience of targeted, immune, progression after conventional therapy, or intolerance (including TKIs,ICIs, chemotherapy, VEGF monoclonal antibody, or ICIs in combination with TKIs/VEGFs monoclonal antibody/chemotherapy)；
- •Child-Pugh liver function rating within 7 days prior to the first dose of study drug: Grade A or better grade B (≤ 7 points) ;
- •Phase B or C as assessed by BCLC; or Phase III as assessed by CNLC;
- •Within 4 weeks prior to the first dose, at least one measurable target lesion remained according to mRECIST v1.1；
- •EGFR postive and RAS wildtype；
排除标准
- •Dignosised as hepatic cholangiocarcinoma, mixed cell carcinoma, or fibrolamellar cell carcinoma；
- •History of hepatic encephalopathy within 6 months prior to the first dose of this study；
- •Portal hypertension with endoscopic red signs, or those who are considered by the investigator to be at high risk of bleeding or who have had esophageal or gastric variceal bleeding within 6 months prior to the first dose；
- •Symptomatic brain or meningeal metastases (unless patient is treated> 3 months, no evidence of progression on imaging within 4 weeks prior to treatment, and tumor-related clinical symptoms is stable)
研究组 & 干预措施
Nimtuzumab combined ICIs
Patients will be treated with nimotuzumab combined immune checkpoint inhibitors treatment
干预措施: Nimotuzumab (Drug)
Nimtuzumab combined ICIs
Patients will be treated with nimotuzumab combined immune checkpoint inhibitors treatment
干预措施: ICIs(Immune checkpoint inhibitors) (Drug)
结局指标
主要结局
ORR（Objtective reseponse rate）
时间窗: up to 24 month
（Objtective reseponse rate）
次要结局
- PFS（pregression free survival）(up to 24 month)
- OS（overall survival）(up to 24 month)
研究者
Jihui Hao
Chief physician
Tianjin Medical University Cancer Institute and Hospital