NCT07304258尚未招募2 期
A Prospective, Phase II Clinical Study of HIPEC Combined With NIPS and Tislelizumab Conversion Therapy for Gastric Cancer With Peritoneal Metastasis With Positive Cytology Alone or PCI Score ≤10
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Surgical Conversion Rate
研究概览
简要总结
This study aims to evaluate the efficacy and safety of HIPEC combined with NIPS and tislelizumab conversion therapy for gastric/gastroesophageal junction cancer with positive cytology alone (CY1P0) or a Peritoneal Carcinomatosis Index (PCI) ≤10
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment-naïve patients who have not received chemotherapy, radiotherapy, or any other antitumor therapy prior to the start of the clinical trial;
- •Age between 18 and 75 years;
- •Male or non-pregnant, non-lactating female;
- •Gastric or gastroesophageal junction adenocarcinoma confirmed by gastroscopy and pathological diagnosis;
- •HER-2 negative by immunohistochemistry (IHC), and PD-L1 CPS ≥1;
- •Laparoscopic exploration confirming either positive cytology alone (P0CY1) or peritoneal metastasis (PCI score ≤10);
- •No other distant metastases;
- •Hematological criteria: white blood cell count ≥3.5×10⁹/L, neutrophils ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, hemoglobin ≥90 g/L;
- •Biochemical criteria: ALT ≤2.5×ULN, AST ≤2.5×ULN, total bilirubin ≤1.5×ULN, serum creatinine ≤1.5×ULN;
- •Left ventricular ejection fraction ≥50%;
- •ECOG performance status 0-1;
- •Ability to comply with the study protocol and voluntarily provide signed informed consent.
排除标准
- •Inability to comply with the study protocol or procedures;
- •Known HER2-positive status;
- •Known diagnosis of squamous cell carcinoma, undifferentiated carcinoma, or other histological types of gastric cancer, or adenocarcinoma mixed with other histological types;
- •Current conditions or diseases affecting drug absorption;
- •Patients preoperatively confirmed as unsuitable for conversion therapy;
- •Severe cardiovascular diseases, such as uncontrolled heart failure, coronary artery disease, arrhythmia, or uncontrolled hypertension;
- •Symptomatic active central nervous system metastases (e.g., clinical symptoms, cerebral edema, spinal cord compression, carcinomatous meningitis, leptomeningeal disease, and/or progressive growth);
- •Known allergy to the investigational drug(s);
- •Prior treatment with anti-PD-1/PD-L1 antibodies, anti-PD-L2 antibodies, anti-CD137 antibodies, anti-CTLA-4 antibodies, or other drugs/antibodies targeting T-cell co-stimulation or checkpoint pathways;
- •Clinically uncontrolled active infections, such as acute pneumonia, active hepatitis B or C (HBV DNA ≥1×10⁴ copies/mL or >2000 IU/mL despite prior antiviral therapy); Known primary immunodeficiency or active tuberculosis; History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; Known history of human immunodeficiency virus (HIV) infection (HIV antibody positive);
- •Significant malnutrition (weight loss ≥5% within 1 month or >15% within 3 months prior to informed consent, or food intake reduced by ≥50% within 1 week), unless corrected for ≥4 weeks before the first dose of investigational drug;
- •History of other primary malignancies, except:
- •Malignancies in complete remission for at least 2 years prior to enrollment with no required treatment during the study;
- •Adequately treated non-melanoma skin cancer or malignant lentigo with no evidence of recurrence;
- •Adequately treated carcinoma in situ with no evidence of recurrence;
- •Female patients who are pregnant or breastfeeding;
- •Any concomitant illness that, in the investigator's judgment, seriously endangers patient safety or affects study completion;
- •Patients deemed ineligible for the study by the investigator.
研究组 & 干预措施
Arm A
Experimental
干预措施: Paclitaxel Injection, S-1, tislelizumab (Drug)
Arm A
Experimental
干预措施: HIPEC (Device)
Arm A
Experimental
干预措施: NIPS (Device)
结局指标
主要结局
Surgical Conversion Rate
时间窗: The day of surgery
Proportion of R0 Resection Patients in the ITT Population
次要结局
- 2-year OS rate(2 years)
- 1-year PFS rate(1 year)
- Progression-free survival（PFS）(3 years)
- Overall survival (OS)(3 years)
- Adverse events(3 years)
研究者
Qun Zhao
Principal Investigator
Hebei Medical University
研究点 (1)
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