肿瘤细胞治疗研究
英文原题：The Construction of a Predictive Model for Gastric Cancer Immunotherapy Response Based on Tumor-Infiltrating Lymphocytes (TILs) and Histone H3K4me3 in the Tumor Microenvironment
⚠ 该试验的登记信息已有 15 个月未更新， 页面上显示的「招募中」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。
这是一项分期未标注的注册临床试验，评估细胞治疗用于胃癌、多发性骨髓瘤的安全性、可行性及初步疗效。当前状态：招募中。计划入组 170 例。试验地点：中国 · 长治（共 1 个中心，其中中国 1 个）。登记号：NCT07069842。
不限性别 · ≥ 18 Years 且 ≤ 75 Years
纳入标准： 1. 年龄18至75岁，组织学确诊局部晚期（LA）不可切除或转移性胃/胃食管结合部（G/GEJ）腺癌。 2. 计划接受一线ICI联合化疗，可联合或不联合抗HER2治疗。 3. 至少有一个按iRECIST V1.1标准定义的可测量靶病灶，ECOG体能状态评分0至2。 排除标准： 1. 研究开始前3年内有继发性恶性肿瘤史，或存在其他类型的脑/脑膜转移瘤。 2. 研究者判断可能严重危及患者安全或妨碍完成研究的合并疾病。
Inclusion Criteria: * 1.Diagnosed with histologically confirmed locally advanced (LA) unresectable or metastatic gastric/gastroesophageal junction (G/GEJ) adenocarcinoma, aged 18 to 75 years. 2.Scheduled to receive first-line therapy with ICIs plus chemotherapy with or without anti-her-2 therapy. 3.Have at least one measurable lesion as the target lesion per iRECIST V.1.1 criteria and an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 Exclusion Criteria: \- 1.History of secondary malignant tumors within 3 years prior to study initiation, or other types of brain/meningeal metastatic tumors. 2.Presence of concomitant diseases that, in the investigator's judgment, may seriously jeopardize their safety or interfere with study completion
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：Response to Immunotherapy in Solid Tumors · 1 year
胃癌是全球死亡率较高的癌症之一，亟需改善治疗结局。免疫治疗的出现突破了胃癌化疗的瓶颈，但患者间疗效差异显著，仍有待提高。大量研究显示，肿瘤微环境（TME）和表观遗传修饰显著影响胃癌免疫治疗疗效。肿瘤浸润淋巴细胞（TIL）和组蛋白H3K4me3的动态变化可能重塑TME，进而影响免疫治疗效果。基于这些发现，本研究提出科学假设：TME中TIL的密度和空间分布，以及H3K4me3修饰水平，可能是预测胃癌患者免疫治疗应答的关键生物标志物。本项目拟深入研究TIL和H3K4me3增强免疫检查点抑制剂（ICI）疗效的潜在机制，并据此构建胃癌免疫治疗应答预测模型。该模型有助于识别最可能从免疫治疗中获益的患者、促进个体化治疗，并为胃癌治疗提供新思路和方法，推动胃癌免疫治疗领域发展。
Gastric cancer is one of the cancers with a high mortality rate globally, and its treatment outcomes urgently need to be improved. The emergence of immunotherapy has broken through the bottleneck of chemotherapy for gastric cancer. However, the therapeutic efficacy of immunotherapy varies significantly among patients and still needs to be enhanced. Extensive research has demonstrated that the efficacy of immunotherapy for gastric cancer is significantly influenced by the tumor microenvironment (TME) and epigenetic modifications. The dynamic changes in tumor-infiltrating lymphocytes (TILs) and histone H3K4me3 may reshape the TME, thereby affecting the efficacy of immunotherapy. Based on these findings, this study proposes the scientific hypothesis that the density and spatial distribution of TILs in the TME, as well as the level of H3K4me3 modification, may serve as key biomarkers for predicting the response of gastric cancer patients to immunotherapy. This project aims to delve into the potential mechanisms by which TILs and H3K4me3 enhance the efficacy of immune checkpoint inhibitors (ICIs) and to construct a predictive model for the response to immunotherapy in gastric cancer based on TILs and H3K4me3. The establishment of this model will help identify the patient population most likely to benefit from immunotherapy, facilitate personalized treatment, provide new ideas and approaches for the treatment of gastric cancer, and advance the field of gastric cancer immunotherapy.
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