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TIL 治疗鼻咽癌:注册临床试验(分期未知)(Jiangxi Provincial)

英文原题:Prognostic Value of TIL in Nasopharyngeal Carcinoma

ClinicalTrials.gov 2025/01/08(首次登记) 注册临床试验(分期未标注) · 邀请入组

⚠ 该试验的登记信息已有 21 个月未更新, 页面上显示的「邀请入组」可能已经失效。联系研究中心之前,建议先到 ClinicalTrials.gov 核对登记原文的最新状态与联系方式。

简要介绍

这是一项分期未标注的注册临床试验,评估细胞治疗用于鼻咽癌的安全性、可行性及初步疗效。当前状态:邀请入组。计划入组 216 例。试验地点:中国 · 南昌(共 1 个中心,其中中国 1 个)。登记号:NCT06763640。

入组条件决定能不能参加

不限性别 · ≥ 18 Years 且 ≤ 70 Years

纳入标准:

• 组织病理学确诊鼻咽癌。
• 初次治疗时无远处转移,分期为II至III期(AJCC第9版)。
• 年龄18至70岁,Karnofsky评分≥80分。
• 器官功能良好,须符合以下条件:
  • 血液学:白细胞>3.0×10^9/L;中性粒细胞绝对计数(ANC)>1.5×10^9/L;血红蛋白>90 g/L;血小板>100×10^9/L;白蛋白≥3 g/dL。
  • 肝功能:胆红素≤正常值上限(ULN)的1.5倍,AST和ALT≤ULN的3倍,碱性磷酸酶(ALP)≤ULN的3倍。
  • 国际标准化比值(INR)、凝血酶原时间(PT)或活化部分凝血活酶时间(APTT)≤ULN的1.5倍。
  • 肾功能:血清肌酐≤ULN的1.5倍或肌酐清除率≥60 mL/min。
• 愿意且能够遵守访视安排、治疗计划、实验室检查及其他研究程序。
• 愿意遵守研究期间各项安排,且不参加其他药物或医疗器械相关临床研究。
• 签署正式知情同意书,确认理解本研究符合医院政策。
• 有足够的石蜡包埋组织块,可供科学研究使用。

排除标准:

• 合并其他恶性肿瘤。
• 对本研究使用的任何药物有严重速发型过敏史。
• 无民事行为能力或限制民事行为能力。
• 药物滥用或酒精成瘾;患有身心疾病,研究者判断其无法充分理解本研究可能发生的并发症。
• 存在可能增加研究方案治疗风险或干扰结果解释的其他严重急慢性疾病(包括免疫介导性结肠炎、炎症性肠病、非感染性肺炎、肺纤维化)或精神疾病(包括痴呆、癫痫,以及近期、过去1年内或当前有自杀意念或行为),或存在相关实验室检查异常;研究者判断患者不适合参加。
• 既往确诊免疫缺陷,或已知HIV/获得性免疫缺陷综合征(AIDS)相关疾病。
• 妊娠或哺乳期女性;或有生育能力但不愿或无法在整个研究期间及治疗结束后至少1年采取避孕措施的男性或女性患者。
核对登记原文(英文)
Inclusion Criteria:

* Histopathology confirms nasopharyngeal carcinoma;
* At the initial treatment, there was no evidence of distant metastasis, and the staging was II-III (AJCC 9th);
* Age range of 18-70 years old, KPS ≥ 80 points;
* Having good organ function; The following conditions must be met: Hematology: White blood cell count\>3.0 × 109/L; Absolute neutrophil count (ANC)\>1.5 × 109/L; Hb\>90g/L; Platelets\>100 × 109/L; Albumin ≥ 3g/dL Liver function: Bilirubin ≤ 1.5 times the upper limit of normal (ULN), AST and ALT ≤ 3 times ULN, and alkaline phosphatase (ALP) ≤ 3 times ULN • International normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤ 1.5 times ULN; • Renal function: Serum creatinine ≤ 1.5 times ULN or creatinine clearance rate ≥ 60mL/min.
* Patients who are willing and able to comply with visit arrangements, treatment plans, laboratory tests, and other research procedures;
* Willing to comply with arrangements during the research period and cannot participate in any other clinical studies related to drugs and medical devices;
* Patients sign a formal informed consent form to indicate that they understand that this study complies with hospital policies.
* Sufficient tissue stored in wax blocks suitable for scientific research use.

Exclusion Criteria:

* Merge with other malignant tumors
* Individuals with a history of severe immediate hypersensitivity to any medication used in this study
* No capacity for civil conduct or limited capacity for civil conduct;
* Abuse of drugs or alcohol addiction, patients with physical or mental illnesses, and those deemed by the researchers to have a complete or thorough understanding of the possible complications of this study;
* Other serious acute or chronic medical conditions (including immune-mediated colitis, inflammatory bowel disease, non-infectious pneumonia, pulmonary fibrosis) or mental illnesses (including dementia and epilepsy, recent, past year, or active suicidal ideation or behavior) that may increase the risks associated with the study protocol treatment, or may interfere with the interpretation of study results and (based on the researcher's judgment) make patients unsuitable for participation in this study, or laboratory test abnormalities;
* Previously diagnosed with immunodeficiency or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related diseases;
* Pregnant or lactating female patients, male or female patients who have fertility but are unwilling or unable to use contraception for at least one year throughout the study period and after the end of the treatment plan.

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

  • 主要终点无病生存期(DFS)3年
  • 次要终点总生存期
  • 次要终点无远处转移生存期
  • 次要终点无局部区域复发生存期
  • 次要终点客观缓解率
核对登记原文(英文)

主要终点:Disease Free Survival (DFS) · DFS was defined as the interval from the date of diagnosis to the data of disease recurrence or death · 3 Years
次要终点:Overall Survival;Distant Metastasis-free Survival;Locoregional Recurrenc-free Survival;Objective Response Rate

研究设计怎么做的

研究类型
观察性研究
入组人数
216 人(预计)

关键日期

开始日期
2025-01-01
主要完成日期
2027-12-31
全部完成日期
2028-12-31
登记状态核实于
2025-01

联系与责任方

申办方
Jiangxi Provincial Cancer Hospital

登记简述

本中心计划开展一项前瞻性、多中心观察性研究,利用深度学习方法分析数字病理图像中的肿瘤浸润淋巴细胞(TIL)浸润比例,并分析其在鼻咽癌中的预后意义,以帮助指导个体化治疗。

核对登记原文(英文)

Our center plans to conduct a prospective, multicenter, observational study aimed at observing the percentage of TIL infiltration calculated using deep learning methods based on digital pathological images, and analyzing its prognostic significance in nasopharyngeal carcinoma, in order to help guide personalized treatment.

登记原文与核验信息

试验登记号
NCT06763640
试验状态
邀请入组
中国试验中心(1 个)
Jiangxi Cancer Hospital · 南昌 · 中国
适应症(原文)
Nasopharyngeal Carcinoma (NPC)