NCT06241781招募中2 期
A Phase 2, Multicenter Randomized Controlled Open-label Study of Autologous Tumor Infiltrating Lymphocytes (GT101 Injection) in Patients With Recurrent or Metastatic Cervical Cancer
Grit Biotechnology25 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2024年4月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 83
- 试验地点
- 25
- 主要终点
- Progression Free Survival
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
GT101 injection treatment group
Experimental
干预措施: GT101 injection (Biological)
Gemcitabine injection treatment group
Active Comparator
干预措施: Gemcitabine injection (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: 3 years
Defined as time from first study treatment until disease progression or death from any cause, whichever occurs first.
次要结局
- Duration of Response(3 years)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(3 years)
研究者
研究点 (25)
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