A Phase 2a Study Using Natural Killer (NK) Cell Therapy Combined With Hepatic Artery Infusion Chemotherapy (HAIC) in Patients With Locally Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Objective Response Rate (ORR) of administering VAX-NK/HCC combined with HAIC
研究概览
简要总结
This Phase 2a trial will evaluate the safety and efficacy of NK cell therapy combined with the hepatic artery infusion chemotherapy (HAIC) in patients with intermediate and/or locally advanced hepatocellular carcinoma (HCC). We hypothesized that 5-fluorouracil (FU) with immunomodulatory functions would relieve the immunosuppressive microenvironment from the myeloid-derived suppressor cells (MDSCs), thereby enhancing the anti-tumor activity of NK cells. Thus, the subsequent infusion of autologous NK cells (VAX-NK/HCC) following HAIC treatment may further improve the anti-tumor activity in patients with advanced HCC.
详细描述
Primary Objective I. To assess the objective response rate (ORR) of administering VAX-NK/HCC, autologous NK cells combined with HAIC in patients with locally advanced HCC.
Secondary Objectives I. To assess the efficacy of administering VAX-NK/HCC combined with HAIC. II. To assess the safety of administering VAX-NK/HCC combined with HAIC. III. To assess the immune responses of administering VAX-NK/HCC combined with HAIC.
OUTLINE: This is a Phase 2a study. Patients receive HAIC treatment every 4 week for up to 4 cycles followed by ex-vivo expanded autologous NK cell infusions. The NK cell treatment repeats every 4 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients will be followed until the disease progression.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with intermediate and/or locally advanced HCC histologically confirmed by biopsy or by typical radiological findings.
- •Subjects who were not suitable for or failed curative treatments such as surgical resection, local ablation therapy, transarterial chemoembolization (TACE), sorafenib, atezolizumab, bevacizumab, etc.
- •Child-Pugh liver function class A or B.
- •Subjects' ECOG performance status of 0 or
- •The presence of macrovascular invasion.
- •Adequate liver, renal, and hematologic functions.
排除标准
- •Subjects who received the immune cell-based therapy within 6 months before the screening visit.
- •Subjects with a history of a malignancy other than HCC within the last 5 years, liver transplantation, and hypersensitivity to 5-FU or cisplatin.
- •Subjects with extra-hepatic metastases.
- •Subjects who have ongoing autoimmune disease.
- •Female subjects who are pregnant or lactating or women of child-bearing potential but unable to take adequate contraception.
结局指标
主要结局
Objective Response Rate (ORR) of administering VAX-NK/HCC combined with HAIC
时间窗: average 6 months
ORR will be measured as the proportion of patients with a best overall response of complete response (CR) and partial response (PR) of administering VAX-NK/HCC combined with HAIC.
次要结局
- Time to progression (TTP) of administering VAX-NK/HCC combined with HAIC(average 6 months)
- The lymphocyte/monocyte ratio (LMR)(average 6 months)
- Quality of Life of administering VAX-NK/HCC combined with HAIC(average 6 months)
- Disease control rate (DCR) of administering VAX-NK/HCC combined with HAIC(average 6 months)
- Overall survival (OS) of administering VAX-NK/HCC combined with HAIC(average 12 months)
- The proportions of T and NK cells(average 6 months)
- The serum cytokine levels(average 6 months)
- Adverse Events (AEs) and Serious Adverse Events (SAEs) of administering VAX-NK/HCC combined with HAIC(average 6 months)
- The NK cell cytotoxicity(average 6 months)