A Single-arm, Prospective Study of HAIC Sequential TAE Combined With Tislelizumab and Surufatinib in Unresectable Intrahepatic Cholangiocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This is a single center, single arm, phase II, prospective study to evaluate the safety and effectiveness of HAIC combined with TAE plus an ICI and an TKI in adult patients (aged ≥18 years) with unresectable intrahepatic cholangiocarcinoma.
详细描述
Compared with systemic intravenous chemotherapy, hepatic arterial infusion chemotherapy(HAIC) has the advantages of increasing local drug concentration and reducing systemic toxic and side effects. All patients were treated with HAIC (Oxaliplatin and Raltitrexed ). Surufatinib was taken orally after meals, once a day, with 3-5 capsules (50mg/capsule) each time； Tislelizumab was given 200mg every 3 weeks. The treatment continued until the patient developed the disease or met the other criteria for terminating the study.
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
- •Written informed consent for the trial.
- •Aged ≥18 years.
- •Histologically confirmed intrahepatic cholangiocarcinoma.
- •No other previous systematic treatment for BTC.
- •At least one measurable lesion (RECIST 1.1).
- •Eastern Cooperative Oncology Group performance status 0 or
- •Life expectancy of 3 months or greater.
- •Child-Pugh classification score ≤7.
排除标准
- •Recurrent patients.
- •Eastern Cooperative Oncology Group performance status ≥
- •Life expectancy of less than 3 months.
- •Child-Pugh classification score >
- •History of hepatic encephalopathy or liver transplantation.
- •Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
- •Symptomatic pleural effusion, ascites, and pericardial effusion that require drainage.
- •Portal vein tumor thrombus (PVTT) involves both the main trunk and contralateral branch or upper mesenteric vein. Inferior vena cava tumor thrombus.
- •Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-CTLA4, etc.).
- •History of (non-infectious) pneumonitis that required steroids, evidence of interstitial lung disease or active, non-infectious pneumonitis.
- •The researcher considers it inappropriate to enter this study.
研究组 & 干预措施
TAE+HAIC+Tislelizumab+Surufatinib
Patients will receive hepatic arterial infusion chemotherapy (HAIC) sequential transcatheter arterial embolization(TAE) combined with Tislelizumab and Surufatinib
干预措施: HAIC+TAE (Drug)
TAE+HAIC+Tislelizumab+Surufatinib
Patients will receive hepatic arterial infusion chemotherapy (HAIC) sequential transcatheter arterial embolization(TAE) combined with Tislelizumab and Surufatinib
干预措施: Tislelizumab (Drug)
TAE+HAIC+Tislelizumab+Surufatinib
Patients will receive hepatic arterial infusion chemotherapy (HAIC) sequential transcatheter arterial embolization(TAE) combined with Tislelizumab and Surufatinib
干预措施: Surufatinib (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: 24 months
the sum of complete response rate and partial response rate
次要结局
- Overall survival (OS)(24 months)
- Conversion to surgical resection rate(3 months)
- Progression-free survival (PFS)(24 months)
- Incidence rate of adverse events(24 months)
- 1-year overall survival rate(12 months)
- Disease Control rate (DCR)(24 months)
研究者
Zhang Zongli
Professor
Qilu Hospital of Shandong University