Transcatheter Hepatic Artery Chemoembolization Combined With Immune Checkpoint Inhibitors for Liver Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
This study will evaluate the efficacy and safety of TACE combined with immune checkpoint inhibitors to treat unresectable hepatocellular carcinoma.
详细描述
The specific operation of TACE is based on the CSCO Diagnosis and Treatment Guidelines for Primary Liver Cancer (2022 Edition). TACE is performed through microcatheters. After TACE, the coaxial catheter is retained in the hepatic artery or left or right hepatic artery branch. The specific body plan is oxaliplatin+calcium folinate+5-Fu (FOLFOX) (J Hepatol, 2018). Oxaliplatin 85mg/m2 was continuously injected through arterial pump for more than 4 hours on the first day. After HAIC is completed, remove the catheter and sheath. Repeat catheterization in the next treatment cycle.
Immune checkpoint inhibitors can be administered arterial starting after the first TACE treatment, q4w (± 3 days). If the situation requires, the arterial administration of ICI can be adjusted forward or backward for 7 days to adapt to TACE treatment.
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
- •Confirmed diagnosis of HCC by histology/ cytology or clinical criteria
- •Sign informed consent
- •When screening for age, the age should be ≥ 18 years old
- •Eligible for TACE treatment
- •ECOG physical condition score is 0 or 1
- •No prior systemic therapy for HCC, especially immunotherapy
- •According to the following mRECIST criteria, at least one measurable intrahepatic lesion is suitable for repeated evaluation
排除标准
- •Have any history of kidney disease or nephrotic syndrome
- •Evidence of extrahepatic spread (EHS)
- •Cardiovascular diseases with clinical significance (such as activity), including unstable angina, ≥ grade 2 congestive heart failure, and arrhythmia with poor drug treatment control
- •Any condition representing a contraindication to TACE as determined by the investigators
- •Known genetic factors for bleeding or thrombosis; Any previous or current evidence indicating a tendency for bleeding
- •Individuals who have received immunotherapy (anti PD-1, anti PD-L1, or anti CTLA-4 treatment)
- •Previously received HAIC (hepatic artery infusion chemotherapy), TACE (hepatic artery chemoembolization), TAE (hepatic artery embolization), or TARE (hepatic artery radiation embolization)
- •Previously received systemic anti-cancer treatment for HCC ,ICC or liver metastasis.
结局指标
主要结局
PFS
时间窗: 3 years
Progression free survival
OS
时间窗: 3 years
Overall Survival
次要结局
- ORR(3 years)
研究者
Haipeng Yu
Professor
Tianjin Medical University Cancer Institute and Hospital