Clinical Study on Adoptive Treatment of Advanced Hepatocellular Carcinoma With Allogeneic γδ-T Cells
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The change of performance status score
研究概览
简要总结
Brief Summary: In this study, effects of γδ T cells on Advanced hepatocyte carcinoma The goal of this clinical trial is to learn about effects of allogeneic γδ T therapy in advanced hepatocyte carcinoma patients.
The main question it aims to answer is:Will advanced hepatocyte carcinoma patients be benefit from allogeneic γδ T therapy? Participants will received GDKM-100injection (allo-γδ T Cells) Infusion every two weeks.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
The change of performance status score
时间窗: up to approximately 16months
In medicine(oncology and Other fields), performance status is an attempt to Quantify cancer patients' general well-being and activities of daily life.This measure is used to determine whether they can receive chemotherapy, whether dose adjustment is necessary，and as a measure for the required intensity of palliative care. It is also used in oncological randomized controlled trials as a measure of quality of life. PS scores range from 1 to 5,with Higher PS score indicating worse prognosis.
Overall Survival
时间窗: Up to 16months
From the date of entry into the clinical study until death from any cause
The Child-Pugh score
时间窗: up to approximately 16months
The Child-Pugh score is a system for assessing the prognosis-including the required strength of treatment and necessity of liver transplant-of chronic liver disease. It provides a forecast of the increasing severity of liver disease and expected survival rate.Child-Pugh scores range from 5 to 15, with higher scores indicating worse prognosis.Class A: 5-6, Class B: 7-9, Class C: 10-15 (minimum 5, maximum 15;)
次要结局
- PFS（Progression-Free Survival )(up to approximately 16months)
- TTP（time to disease progression )(up to approximately 16months)
- DoR(duration of remission )(up to approximately 16months)
- ORR（objective remission rate ）(up to approximately 16months)
- DCR (disease control rate)(up to approximately 16months)