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

Обзор

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

Вмешательства

• Устройство HIPEC
  HIPEC protocol: Paclitaxel Injection, 75mg/m², D1, D3, D5, for three cycles, followed by a two-week rest before initiating NIPS combined with systemic therapy.
• Устройство NIPS
  Paclitaxel Injection for intraperitoneal perfusion at a dose of 20mg/m² on D1 and D8; Q3W.
• Препарат Paclitaxel Injection, S-1, tislelizumab
  Paclitaxel Injection: 50mg/m², iv, D1, D8; Q3W; Tegafur Gimeracil Oteracil Potassium Capsules (S-1):For body surface area (BSA) \<1.25, 40mg per dose; BSA ≥1.25 to \<1.5, 50mg per dose; BSA ≥1.5, 60mg per dose; po, bid, D1-D14; Q3W; Tislelizumab: 200mg per administration, intravenous drip over 30 minutes (not less than 20 minutes and not exceeding 60 minutes), D1, Q3W.

Первичные конечные точки

• Surgical Conversion Rate [Срок оценки: The day of surgery]

Вторичные конечные точки (5)

• 1-year PFS rate [Срок оценки: 1 year]
• 2-year OS rate [Срок оценки: 2 years]
• Progression-free survival（PFS） [Срок оценки: 3 years]
• Overall survival (OS) [Срок оценки: 3 years]
• Adverse events [Срок оценки: 3 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fourth Affiliated Hospital of Hebei Medical University — Shijiazhuang

Идентификаторы

NCT: NCT07304258 · HIPEC-NIPS-T Trial

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗