NCT07166263尚未招募1 期
Exploratory Study of NK510 Cell Therapy in the Treatment of Recurrent and Refractory Advanced Gastric Cancer and Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Dose-Limiting Toxicity
研究概览
简要总结
This study will evaluate the safety and efficacy of NK510 in the treatment of relapsed and refractory advanced gastric cancer and colorectal cancer.NK510 will be administered by intravenous infusion for systemic therapy and intraperitoneal perfusion therapy. The safety and efficacy of this treatment will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 18 years, regardless of gender.
- •Gastric cancer and colorectal cancer that are inoperable and unresectable with radiotherapy: For gastric cancer, molecular diagnosis confirms that it is not AFP-producing gastric cancer.
- •Progressive disease or recurrence after receiving ≥ 2 lines of treatment.
- •Patients are divided into two groups (Group A and Group B) based on the presence or absence of peritoneal metastasis. The criteria for determining peritoneal metastasis are as follows:
- •Drained ascites ≥ 500ml, or B-ultrasound/CT in the supine position shows ascites depth ≥ 3cm.
- •Peritoneal metastasis confirmed by any of the following criteria:
- •i. Positive for exfoliated cancer cells in ascites. ii. Diagnosed as peritoneal metastatic carcinoma by imaging and symptoms. iii. Peritoneal metastasis confirmed by abdominal exploration. iv. Ascites confirmed as exudate by routine ascites examination and ascites biochemistry.
- •At least one measurable lesion on CT or MRI according to RECIST v1.1 (Response Evaluation Criteria in Solid Tumors).
- •ECOG performance status of 0-
- •Expected survival period ≥ 3 months.
- •Able to comply with the study protocol and follow-up procedures, and voluntarily sign the informed consent form for participation in this study.
排除标准
- •Pregnant or lactating women.
- •Subjects with central nervous system (CNS) metastases and/or carcinomatous meningitis with obvious symptoms.
- •A history of other malignant tumors within the past 3 years.
- •Subjects with active, known or suspected autoimmune diseases [excluding type 1 diabetes, hypothyroidism requiring only hormone replacement therapy, skin diseases that do not require systemic treatment (e.g., vitiligo, psoriasis, or alopecia), or diseases that are not expected to relapse without external triggers].
- •Subjects with a history of immunodeficiency, including positive HIV test results, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
- •A history of severe cardiovascular and cerebrovascular diseases, including but not limited to: severe cardiac rhythm or conduction abnormalities such as ventricular arrhythmias requiring clinical intervention, third-degree atrioventricular block, etc.; QTc interval > 480 ms on 12-lead electrocardiogram at rest; acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events within 6 months before enrollment; New York Heart Association (NYHA) cardiac function classification ≥ class II or left ventricular ejection fraction (LVEF) < 50%; clinically uncontrolled hypertension.
研究组 & 干预措施
Systemic therapy with NK510 via intravenous infusion
Experimental
Systemic therapy with NK510 via intravenous infusion combined with PD-L1 or other regimens selected by the investigator
干预措施: NK510 (Drug)
Intraperitoneal perfusion therapy with NK510
Experimental
Intraperitoneal perfusion therapy with NK510 plus IL-2, PD-L1 or other regimens selected by the investigator for systemic therapy
干预措施: NK510 (Drug)
结局指标
主要结局
Dose-Limiting Toxicity
时间窗: 6 weeks
To evaluate the DLT during N510 treatment
Overall response rate (ORR)
时间窗: 6 weeks
Effectiveness Metrics
Puncture-free survival (PuFS)
时间窗: 6 weeks
Effectiveness Metrics
次要结局
- Progression-free survival (PFS)(2 years)
研究者
研究点 (1)
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