肿瘤细胞治疗研究
英文原题：Sintilimab With P-GEMOX Versus the P-GEMOX in the Teatment of Advanced-stage Extranodal Natural Killer/T Cell Lymphoma
这是一项 II 期注册临床试验，评估肿瘤浸润淋巴细胞治疗淋巴瘤的安全性、可行性及初步疗效。当前状态：招募中。计划入组 84 例。试验地点：中国 · 广州（共 1 个中心，其中中国 1 个）。登记号：NCT06583083。
不限性别 · ≥ 18 Years
纳入标准： 1. 病理学确诊为ENKTL。 2. 晚期。 3. 至少有一个可测量或可评估的病灶。 4. 年龄 > 18岁，无性别限制，预期生存期超过3个月。 5. 愿意参加临床研究；充分知情并已签署书面知情同意书。 6. 器官和骨髓功能良好。 排除标准： 1. 侵袭性NK细胞白血病。 2. 中枢神经系统受累。 3. 重要器官存在显著功能障碍的患者。 4. 对研究药物、同类药物或辅料有过敏史。 5. 距大器官手术不足6周（不包括以活检为目的的手术）。 6. 妊娠或哺乳期女性，以及不愿采取避孕措施的育龄女性。 7. 活动性感染，不包括与肿瘤相关B症状有关的发热。 8. 已知有人类免疫缺陷病毒（HIV）感染和/或获得性免疫缺陷综合征（AIDS）病史。
Inclusion Criteria: 1. Pathologically diagnosed with ENKTL. 2. Advanced stage. 3. Has at least one measurable or assessable lesion. 4. Age \> 18 years, no gender restrictions, with an expected survival of more than 3 months. 5. Willing to participate in the clinical study; fully informed and has signed a written informed consent form. 6. Adequate organ and bone marrow function. Exclusion Criteria: 1. Aggressive NK-cell leukemia. 2. Central nervous system involvement. 3. Patients with significant dysfunction of vital organs. 4. History of allergy to the investigational drug, similar drugs, or excipients. 5. Less than 6 weeks since major organ surgery (excluding surgery for biopsy purposes). 6. Pregnant or breastfeeding women, and women of childbearing potential who are unwilling to use contraception. 7. Active infection, excluding fever related to tumor-associated B symptoms. 8. Known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome (AIDS).
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：PFS · progression free survival · Up to 4 years
次要终点：ORR rate；CR rate；OS；Adverse events
Sintilimab联合P-GEMOX方案
P-GEMOX方案
结外NK/T细胞淋巴瘤是一种罕见且高度侵袭性的非霍奇金淋巴瘤亚型。虽然早期ENKTL患者的总体生存率有所提高，但晚期患者的预后仍然较差，目前尚无标准治疗方案。PD-1/PD-L1抑制剂已在多种癌症中显示出显著疗效，近期研究在结外NK/T细胞淋巴瘤中也显示出令人鼓舞的结果。尽管PD-1抗体在复发或难治性患者中表现出疗效，但其与化疗联合作为一线治疗的有效性仍不明确。本研究旨在通过随机对照试验评估信迪利单抗联合化疗在新诊断晚期结外NK/T细胞淋巴瘤患者中的疗效和安全性，同时探索可能预测治疗结果的潜在生物标志物，为结外NK/T细胞淋巴瘤患者提供新的治疗选择。
Extranodal NK/T-cell lymphoma is a rare and highly aggressive subtype of non-Hodgkin lymphoma. While the overall survival rates have improved for early-stage ENKTL patients, the prognosis for those with advanced disease remains poor, and there is currently no standard treatment. PD-1/PD-L1 inhibitors have demonstrated significant efficacy in various cancers, and recent studies have shown promising results in extranodal NK/T-cell lymphoma as well. Although PD-1 antibodies have exhibited efficacy in relapsed or refractory patients, their effectiveness when combined with chemotherapy as a first-line treatment remains unclear. This study aims to evaluate the efficacy and safety of sintilimab combined with chemotherapy in a randomized controlled trial for newly diagnosed advanced extranodal NK/T-cell lymphoma patients, while also exploring potential biomarkers that may predict treatment outcomes, offering new therapeutic options for extranodal NK/T-cell lymphoma patients.
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