← 返回临床试验

自体树突状细胞和异体树突状细胞分泌组治疗晚期鼻咽癌

英文原题:Autologous Dendritic Cells and Allogenic Dendritic Secretomes for Patients With Advanced Nasopharyngeal Cancer

ClinicalTrials.gov 2022/03/02(首次登记) I/II 期注册临床试验 · 进行中(不再招募)

简要介绍

这是一项 I/II 期注册临床试验,评估自体树突状细胞治疗鼻咽癌的安全性、可行性及初步疗效。当前状态:进行中(不再招募)。计划入组 15 例。试验地点:亚太其他 · 雅加达(共 1 个中心)。登记号:NCT05261750。

入组条件决定能不能参加

不限性别 · ≥ 18 Years 且 ≤ 80 Years

纳入标准:EBV阳性并确诊晚期鼻咽癌;按RECIST标准,放疗或放化疗标准治疗后部分缓解、疾病稳定或进展;过去2个月未服用传统草药;能够理解研究并愿签署知情同意;过去1个月内接受标准放疗/放化疗,最多接受过额外一种治疗。

排除标准:妊娠、计划妊娠或哺乳;研究期间需放化疗;标准治疗后按RECIST达到完全缓解;自身免疫反应、湿疹、过敏史或过敏性休克;肌酐清除率<40 mL/min、胆红素>ULN 1.5倍或SGPT/SGOT>ULN 5倍;使用皮质类固醇等免疫抑制药;重大胸腹部手术史;未控制感染导致医疗风险高;乙肝、丙肝或HIV阳性;充血性心衰或其他心脏病史;医生判断不适合;拒绝或未参加部分/全部研究流程。
核对登记原文(英文)
Inclusion Criteria:

* Patients who tested positive EBV and confirmed suffering advanced nasopharyngeal cancer
* Patients who have partial response or stable disease or progressive disease after performed standard therapy (radiology or chemoradiation) based on RECIST
* Did not take traditional medicine in the last 2 months.
* Patients can understand the nature of the study and willing to sign informed consent
* Patients who received standard medical (radiology or chemoradiation) up to one additional therapy in the last 1 month.

Exclusion Criteria:

* Patients who are pregnant, planning to pregnant, or breastfeeding
* Patients assessed to require chemoradiation during this study
* Patients who get complete score after undergo standard therapy (radiology or chemoradiation) based on the RECIST
* Patients who have autoimun reaction, eczema, allergy or allergy history, and anaphylaxis
* Patients who have creatinin clearance result \<40 ml/min, bilirubin serum \>1.5x above normal, SGPT-SGOT \>5x above normal
* Patients on immunosuppressive medications, such as corticosteroids
* Patients who undergo Major thoracic or abdominal operation
* Patients on high medical risk condition due to uncontrolled infection
* Patients who diagnosed positive of Hepatitis B, Hepatitis C or Human Immunodeificiency virus (HIV)
* Patients who have concurrent congestive heart failure history and other heart disease
* Patients who have health conditions assessed by the doctor in charge cannot be included in this clinical trial
* Patients who refuse or did not participate in part or all of the research process

以上为辅助阅读译文。是否适合入组须由主治医生判断,最终以登记平台与研究者确认为准。

研究终点衡量什么算有效

  • 主要终点Karnofsky体能状态评分治疗前。
  • 主要终点Karnofsky体能状态评分治疗后1周。
  • 主要终点Karnofsky体能状态评分治疗后1个月。
  • 主要终点Karnofsky体能状态评分治疗后3个月。
核对登记原文(英文)

主要终点:Karnofsky Performance Status · To measure the patient's Quality of Life. Karnofsky Performance Status can be used to determine patient's prognosis and measured changes of patient's ability to do daily activities which ranges from 0-100. · Before therapy;Karnofsky Performance Status · To measure the patient's Quality of Life. Karnofsky Performance Status can be used to determine patient's prognosis and measured changes of patient's ability to do daily activities which ranges from 0-100. · 1 week after therapy;Karnofsky Performance Status · To measure the patient's Quality of Life. Karnofsky Performance Status can be used to determine patient's prognosis and measured changes of patient's ability to do daily activities which ranges from 0-100. · 1 month after therapy;Karnofsky Performance Status · To measure the patient's Quality of Life. Karnofsky Performance Status can be used to determine patient's prognosis and measured changes of patient's ability to do daily activities which ranges from 0-100. · 3 months after therapy

研究设计怎么做的

研究类型
干预性研究
入组人数
15 人(预计)
分组方式
随机分组
  • 安慰剂(Aqua Pro-Injection)安慰剂对照组

    肌内注射Aqua Pro-Injection两次,间隔2天。

  • 自体树突状细胞(辅助治疗)试验组

    先肌内注射Aqua Pro-Injection,两天后肌内注射自体树突状细胞。

  • 自体DC联合异体DC分泌组试验组

    先肌内注射异体DC分泌组,两天后肌内注射自体DC。

核对分组登记原文(英文)
  • Placebo (Aqua Pro-Injection) · PLACEBO_COMPARATOR · Subject will given 2 times injection of Aqua Pro-Injection via intramuscular (interval 2 days).
  • Auto-DC (Autologous Dendritic Cell as Adjuvant Therapy) · EXPERIMENTAL · Subject will given injection of Aqua Pro-Injection via intramuscular, two days after followed by Auto-DC via intramuscular.
  • Combination of Auto DC and Allo-DC-Secretome · EXPERIMENTAL · Subject will given injection of Allo-DC-Secretome via intramuscular, two days after followed by Auto-DC via intramuscular.

关键日期

开始日期
2022-04-30
主要完成日期
2026-02-28
全部完成日期
2026-02-28
登记状态核实于
2026-02

联系与责任方

申办方
PT. Prodia Stem Cell Indonesia

登记简述

本研究评估树突状细胞治疗和树突状细胞分泌组治疗晚期鼻咽癌的安全性和潜在效果。

核对登记原文(英文)

The purpose of this study is to determine the safety and potential of dendritic cells therapy and secretomes therapy for advanced nasopharyngeal cancer.

登记原文与核验信息

试验登记号
NCT05261750
试验期别
I 期 / II 期
试验状态
进行中(不再招募)
试验中心
PT Prodia StemCell Indonesia · 雅加达 · 印度尼西亚
适应症(原文)
Nasopharyngeal Cancer
干预方式(原文)
Placebo (Aqua Pro-Injection); Auto-DC (Autologous Dendritic Cell as Adjuvant Therapy); Combination of Auto DC and Allo-Dendritic Cell-Secretome (Allogeneic Dendritic Cell-Secretome as Adjuvant Therapy)