NCT07619937已完成2 期
Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Combined With Tislelizumab and Regorafenib as First-Line Therapy for Advanced Cholangiocarcinoma: A Single-Centre, Single-Arm, Phase II Trial
The First Affiliated Hospital of Zhengzhou University1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2022年7月22日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) combined with tislelizumab and regorafenib as first-line therapy in patients with locally advanced or metastatic cholangiocarcinoma.
The main questions it aims to answer are:
- What is the objective response rate (ORR) of this combination regimen according to RECIST 1.1 criteria
- What are the disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety profile associated with this treatment
Participants will:Receive hepatic arterial infusion chemotherapy (HAIC)+ tislelizumab (PD-1 inhibitor)+regorafenib (oral multikinase inhibitor). Undergo regular imaging assessments to evaluate tumor response per RECIST 1.1.Be monitored for survival outcomes and adverse events throughout treatment and follow-up.
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 years ;
- •Histologically or cytologically confirmed unresectable locally advanced or metastatic intra- or extrahepatic cholangiocarcinoma ;
- •Clinical stage III-IV according to the 8th edition of the AJCC TNM classification ;
- •No prior antitumor therapy;
- •Child-Pugh liver function class A or B ;
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
- •At least one measurable lesion per RECIST 1.1 ;
- •Adequate haematologic and hepatic/renal function;
- •Total bilirubin ≤ 2× upper limit of normal (patients who have undergone biliary drainage are eligible) ;
- •Adequate cardiac and pulmonary reserves to tolerate interventional procedures ;
- •Signed informed consent, good compliance, and ability to attend follow-up visits.
排除标准
- •Contraindications to transarterial chemoembolization, targeted therapy, or immunotherapy ;
- •Prior antitumor treatment ;
- •Concurrent primary malignancies;
- •Child-Pugh class C;
- •Severe cardiac, pulmonary, or renal dysfunction ;
- •Active autoimmune disease or need for long-term immunosuppressive therapy ;
- •Hypersensitivity to contrast agents or study drugs ;
- •Pregnancy or lactation;
- •Anticoagulant or thrombolytic therapy within 3 months before enrollment or bleeding diathesis.
研究者
zhen li
Department of Interventional Radiology
The First Affiliated Hospital of Zhengzhou University
研究点 (1)
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