肿瘤浸润 B 细胞抑制鼻咽癌转移
Tumor-infiltrating B cells inhibit nasopharyngeal carcinoma metastasis.
本研究表明,TIL-B在NPC的抗肿瘤免疫中发挥重要的调节作用,并提示其治疗潜力,为开发基于B细胞或靶向TLS的免疫治疗策略提供了依据。
英文原题:Autologous Dendritic Cells and Allogenic Dendritic Secretomes for Patients With Advanced Nasopharyngeal Cancer
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。
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。
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。
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
肌内注射Aqua Pro-Injection两次,间隔2天。
先肌内注射Aqua Pro-Injection,两天后肌内注射自体树突状细胞。
先肌内注射异体DC分泌组,两天后肌内注射自体DC。
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。
The purpose of this study is to determine the safety and potential of dendritic cells therapy and secretomes therapy for advanced nasopharyngeal cancer.
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