NCT05489692已完成不适用
Hepatic Arterial Infusion Chemotherapy Plus Targeted Therapy and/or PD-1 Inhibitors as Conversion Treatment for Unresectable Intrahepatic Cholangiocarcinoma
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2017年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Tumor Response
研究概览
简要总结
Intrahepatic cholangiocarcinoma (ICC) is associated with poor prognosis. This study aims to explore the efficacy and safety FOLFOX-HAIC in combination with targeted therapy and/or PD-1 inhibitors for patients with initially unresectable ICC, as well as its role in conversion therapy. Data were retrospectively reviewed for patients with locally advanced unresectable ICC treated with FOLFOX-HAIC combined with targeted therapy and/or PD-1 inhibitors. The treatment efficacy and safety were evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients were initially diagnosed without any previous oncological treatment.
- •The tumor was assessed as unresectable by two hepatobiliary surgeons (BL and YY, with more than 15 years of experience). Any of the following conditions: (1) Residual liver volume less than 30-40%; (2) Not possible for R0 radical resection; (3) Tumor invades the portal vein, hepatic artery and bile duct, and the normal residual liver cannot be guaranteed blood supply and bile drainage; the tumor involves the hepatic veins and cannot preserve at least one vein.
- •At least one assessable intrahepatic lesion.
- •classified as Child-Pugh Grade A.
- •ECOG PS score 0-
- •baseline blood tests meet the following criteria: leukocytes ≥3.0×10^9/L; neutrophils ≥1.5×10^9/L; platelets ≥75×10^9/L; hemoglobin ≥ 80g/L; serum ALT or AST ≤ 3 times of upper limit of normal (ULN); serum creatinine ≤1.5 x ULN; INR ≤ 1.5, or prothrombin time ≤ ULN + 4 seconds; albumin ≥ 30 g/L; total bilirubin ≤ 3 x ULN.
排除标准
- •severe underlying cardiac, pulmonary, or renal diseases.
- •a second primary malignancy.
- •prior history of organ transplantation.
结局指标
主要结局
Tumor Response
时间窗: 12 months
The tumor responses were evaluated by measuring the longest diameter of target lesions according to response evaluation criteria in solid tumors (RECIST) version 1.1
次要结局
- Progression-free survival(24 months)
- Conversion rate(24 months)
- Overall survival(24 months)
研究者
Yunfei Yuan
Professor
Sun Yat-sen University
研究点 (1)
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