肿瘤细胞治疗研究
英文原题：Autologous Tumor Infiltrating Lymphocytes (GT101 Injection) in Patients With Recurrent or Metastatic Cervical Cancer
这是一项 II 期注册临床试验，评估细胞治疗用于相关疾病的安全性、可行性及初步疗效。当前状态：招募中。计划入组 83 例。试验地点：中国 · 北京、福州、深圳、桂林（共 24 个中心，其中中国 24 个）。登记号：NCT06241781。
仅女性 · ≥ 18 Years 且 ≤ 70 Years
入选标准 1. 患者或其法定授权代表能够理解研究要求，并已签署经机构审查委员会/独立伦理委员会（IRB/IEC）批准的书面知情同意书。 2. 签署知情同意时年龄18至70岁。 3. 组织学或细胞学确诊不可切除的复发/转移性宫颈癌，且既往至少接受过一线全身治疗。 4. ECOG体能状态0或1。 5. 预期生存期≥12周。 6. 重要器官及骨髓功能充分。 7. 肿瘤切除前，须有影像学记录证实自末次治疗以来疾病进展。 8. 按RECIST 1.1标准有可测量病灶（除已切除病灶外还须有其他可测量病灶）。 排除标准 1. 研究者判断存在无法控制的肿瘤相关疼痛。需使用止痛药者，入组时疼痛管理方案须已稳定；适合姑息放疗的症状性病灶须在入组前完成放疗。 2. 有精神障碍、酒精/药物/其他物质滥用。 3. 妊娠或哺乳，或计划在细胞输注后1年内怀孕。 4. 筛选前4周内参加其他临床试验，或计划同时参加本研究及其他临床试验。 5. 研究者酌情判断的其他不适合参加研究的情况。
Inclusion Criteria: * 1\. The Patients (or legally authorized representative) Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) ,must have the ability to understand the requirements of the study); * 2\. The patient must be 18 to 70 years of age at the time of consent; * 3\. Must have a confirmed diagnosis of malignancy of their receptive histologies or cytology: unresectable recurrent or metastatic cervical carcinomas and previously received≥ 1 prior systemic therapy; * 4\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; * 5\. Expected survival time of ≥ 12 weeks; * 6\. Adequate normal organ and marrow function; * 7\. Before tumor resection, the confirmatory imaging of disease progress since last treatment should be documented. * 8.Patients must have measurable disease measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria (in addition to the resected lesion). Exclusion Criteria: * 1.Patients with uncontrollable tumor-related pain as judged by the investigator; participants requiring painkiller must already have had a stable pain management options at the time of study entry; symptomatic lesions suitable for palliative radiotherapy should be completed prior to study entry; * 2.Patients who have psychiatric disorders, alcohol, drug or substance abuse; * 3.Women who are pregnant or breastfeeding, or planning to become pregnant within 1 year after cell infusion; * 4.Participate in other clinical trials within 4 weeks prior to screening, or planning to participate in this study and other clinical trials at the same time; * 5.Any other conditions that would make the patient unsuitable candidate for the study at the discretion of the investigator.
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：Progression Free Survival · Defined as time from first study treatment until disease progression or death from any cause, whichever occurs first. · 3 years
次要终点：Duration of Response；Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
接受自体肿瘤浸润淋巴细胞（TIL）GT101注射液治疗。
接受吉西他滨注射液治疗。
这是一项II期、多中心、开放标签、随机、平行分组治疗研究，比较自体肿瘤浸润淋巴细胞（GT101注射液）与吉西他滨治疗复发/转移性宫颈癌受试者的疗效和安全性。
This is a Phase II, multicenter, open-label, randomized, parallel group, treatment study to assess the efficacy and safety of Autologous Tumor Infiltrating Lymphocytes (GT101 injection) compared with Gemcitabine in participants with recurrent or metastatic cervical cancer.
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