肿瘤细胞治疗研究
英文原题：Screening Study of Combined Sequential Chemotherapy and Radiation Therapy for Early-stage NK/T-cell Lymphoma
这是一项 II 期注册临床试验，评估TIL（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 210 例。试验地点：中国 · 福州、南通、上海、杭州（共 7 个中心，其中中国 7 个）。登记号：NCT06314334。
不限性别 · ≥ 18 Years 且 ≤ 75 Years
纳入标准： * 病理检查符合WHO-2016版NKTCL诊断标准； * 原发病灶位于上呼吸消化道，如鼻腔、鼻窦、鼻咽、口咽或口腔；依据2014年Lugano标准进行PET/CT和骨髓检查，临床分期为IE/IIE； * 按2014年Lugano标准评估淋巴瘤疗效，至少有一个可测量病灶或可由PET/CT评估的病灶； * 既往未接受淋巴瘤化疗、放疗、免疫治疗或生物治疗； * 年龄18–75岁，性别不限； * ECOG体能状态0–2； * 器官和骨髓功能充分：血液学ANC≥1.0×10⁹/L、血小板≥75×10⁹/L、血红蛋白≥90 g/L，且前14天未使用G-CSF、输注血小板或红细胞；肝功能总胆红素≤ULN的1.5倍、ALT和AST≤ULN的2倍；肾功能血清肌酐≤ULN的1.5倍；凝血功能纤维蛋白原≥1.5 g/L；心脏功能LVEF≥50%，心电图无急性心肌梗死、心律失常或≥Ⅰ度房室传导阻滞； * 愿意遵守研究方案、随访计划及实验室/辅助检查。 排除标准： * 合并HCV、HIV或HBV感染，且血浆HBV-DNA>10³/mL； * 胰腺炎病史； * 急性或全身感染且需要静脉抗生素治疗； * 噬血细胞综合征、弥散性血管内凝血（DIC）等严重并发症； * 重要器官功能障碍，如呼吸衰竭、NYHA≥Ⅱ级慢性充血性心衰、失代偿肝肾功能不全、积极治疗仍未控制的高血压或糖尿病，或过去6个月内心血管血栓/出血事件； * 有不适合接受免疫检查点抑制剂的自身免疫病史； * 妊娠或哺乳； * 精神障碍； * 对化疗方案药物已知过敏； * 过去6个月内合并需手术或化疗的其他肿瘤； * 当前使用其他试验药物。
Inclusion Criteria: * Patients who meet the diagnostic criteria for NKTCL (WHO-2016) based on pathological examination. * Primary lesions located in the upper respiratory and digestive tract such as the nasal cavity, sinuses, nasopharynx, oropharynx, or oral cavity, with clinical staging of IE/IIE based on PET/CT and bone marrow examination according to the Lugano 2014 criteria. * Evaluated for lymphoma response according to the Lugano 2014 criteria, with at least one measurable lesion or lesion assessable by PET/CT. * No prior treatment with chemotherapy, radiotherapy, immunotherapy, or biological therapy for lymphoma. * Age between 18 and 75 years, both genders. * Eastern Cooperative Oncology Group performance status (ECOG) score of 0-2. * Must have adequate organ and bone marrow function, defined as follows: Hematology: Absolute neutrophil count (ANC) ≥1.0×10\^9/L, platelet count (PLT) ≥75×10\^9/L, hemoglobin (Hb) ≥90g/L; no administration of granulocyte colony-stimulating factor, platelet transfusion, or red blood cell transfusion in the previous 14 days. Liver function: Total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2×ULN. Renal function: Serum creatinine (Cr) ≤1.5×ULN. Coagulation function: Plasma fibrinogen ≥1.5g/L. Cardiac function: Left ventricular ejection fraction (LVEF) ≥50%, no acute myocardial infarction, arrhythmia, or atrioventricular conduction block of grade I or above on electrocardiogram. * Willing to comply with the study protocol, follow-up plan, and laboratory and ancillary investigations. Exclusion Criteria: * Patients co-infected with HCV, HIV, or HBV with plasma HBV-DNA \>10\^3/ml. * Patients with a history of pancreatitis. * Patients with acute or systemic infections requiring intravenous antibiotic therapy. * Patients with severe complications such as hemophagocytic syndrome, DIC, etc. * Significant organ dysfunction: such as respiratory failure, chronic congestive heart failure with NYHA class ≥2, decompensated liver or renal dysfunction, uncontrolled hypertension and diabetes despite aggressive treatment, and cardiovascular thrombotic or hemorrhagic events in the past 6 months. * Patients with a history of autoimmune diseases who are not suitable for treatment with immune checkpoint inhibitors. * Pregnant and lactating women. * Patients with psychiatric disorders. * Known allergies to drugs in the chemotherapy regimen. * Patients with concomitant other tumors requiring surgery or chemotherapy within the past 6 months. * Currently using other experimental drugs.
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：PFS24 · Rate of patients with 24-month progression-free survival · From date of randomization until the date of first documented progression, assessed up to 24 months by the Lugano 2014 response criteria.
次要终点：ORR；OS；EFS；TRAE
接受4个周期信迪利单抗联合培门冬酶治疗，每周期3周，共4周期；同时接受调强放疗（IMRT，50–56 Gy），放疗在首次信迪利单抗治疗后21天内开始。
接受4个周期PGEMOX化疗，每周期3周；末次化疗后4周内序贯接受IMRT放疗（50–56 Gy）。
先接受2个周期GELAD化疗，每周期3周；第二周期后4周内接受IMRT放疗（50–56 Gy）；放疗结束后再接受2个周期GELAD化疗。
结外鼻型NK/T细胞淋巴瘤（NKTCL）是东亚人群常见的恶性肿瘤，常起源于鼻腔并扩散至其他器官，与EB病毒（EBV）感染相关，侵袭性较强。早期患者通常接受化疗和放疗，疗效较好。近期研究显示免疫检查点抑制剂可能用于NKTCL治疗，但最佳治疗顺序和疗效仍不清楚。 本研究比较三种治疗策略：A）培门冬酶联合信迪利单抗并同步放疗；B）PGemOx化疗后序贯放疗；C）GELAD夹心式放化疗。研究旨在根据24个月无进展生存期（PFS）确定最佳治疗方案。
Extranodal NK/T-cell lymphoma, nasal type (NKTCL) is a common malignant tumor in East Asian populations, often starting in the nasal cavity and spreading to other organs. Associated with EBV infection, NKTCL is aggressive. Early-stage patients typically receive chemo and radiotherapy, with promising outcomes. Recent studies show the potential of immune checkpoint inhibitors in NKTCL treatment. However, optimal treatment sequencing and efficacy remain unclear. This study aims to compare three strategies: (A) Pegaspargase with Sintilimab and radiotherapy; (B) chemo then radiotherapy (PGemOx); (C) sandwich chemoradiotherapy (GELAD). The goal is to identify the best treatment based on 24-month progression-free survival.
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