跳至主要内容
临床试验/NCT06784765
NCT06784765招募中不适用

Preventive Use of Pressurized Intraperitoneal Aerosol Chemotherapy in Locally Advanced Gastric Cancer: A Non-Randomized Controlled Study

National Research Oncology and Transplantology Center, Kazakhstan2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2025年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
160
试验地点
2
主要终点
Incidence of peritoneal carcinomatosis

研究概览

简要总结

Gastric cancer is the fifth most common cancer worldwide and the third leading cause of cancer-related mortality. In patients with locally advanced gastric cancer, multimodal treatment strategies, including perioperative chemotherapy, have significantly improved survival rates. Despite these advances, peritoneal carcinomatosis (PC) remains a serious problem, occurring in 60% of cases after radical surgery. PC is associated with poor prognosis and limited treatment options.

Intra-abdominal chemotherapy, particularly hyperthermic intraperitoneal chemoperfusion (HIPEC), has demonstrated advantages in the treatment of PC. However, a new technique, pressurized intraperitoneal aerosolized chemotherapy (PIPAC), is emerging as a promising alternative. PIPAC delivers chemotherapeutic agents directly to the peritoneal surface as an aerosol, allowing deeper penetration of drugs into tumor implants while minimizing toxicity and invasiveness.

This study hypothesizes that the addition of PIPAC as a preoperative treatment for patients with locally advanced gastric cancer may reduce the incidence of peritoneal carcinomatosis compared to standard therapy. The primary objective of this study is to determine whether preoperative PIPAC reduces the incidence of peritoneal carcinomatosis in these patients.

详细描述

Gastric cancer is the fifth most common cancer globally and the third leading cause of cancer-related death. In patients with locally advanced gastric cancer, multimodal treatment strategies, including perioperative chemotherapy, have significantly improved survival outcomes. However, PC remains a major challenge, often occurring in 60% of cases after radical surgery, and is associated with a poor prognosis and limited treatment options.

Intra-abdominal chemotherapy, particularly HIPEC, has shown benefits in the treatment of PC. However, a newer method, PIPAC, is emerging as a promising alternative. PIPAC delivers chemotherapeutic agents directly to the peritoneal surface via aerosol, ensuring deeper penetration of the drugs into tumor implants and offering lower toxicity and less invasiveness compared to traditional methods.

This study hypothesizes that adding PIPAC as a preoperative treatment in patients with locally advanced gastric cancer may reduce the occurrence of peritoneal carcinomatosis compared to standard therapy alone. PIPAC will be applied before neoadjuvant chemotherapy to patients at high risk for peritoneal recurrence, with the goal of improving survival rates and reducing recurrence after surgery.

The main objectives of this study are to determine whether preoperative PIPAC reduces the incidence of peritoneal carcinomatosis in patients with locally advanced gastric cancer. Secondary objectives include assessing overall survival (OS), progression-free survival (PFS), disease-free survival (DFS), the occurrence of serious adverse events (SAEs), quality of life (QoL) as measured by the EORTC QLQ-C30, postoperative mortality (Clavien-Dindo classification), and pathological response (TRG) in comparison to patients receiving standard treatment.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
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

入选标准

  • Adults aged 18-70 years with histologically confirmed locally advanced gastric adenocarcinoma (T3-4N0-3M0), ECOG performance status 0-2, and negative peritoneal cytology.
  • Inclusion Criteria:
  • Signed informed consent
  • Aged 18-70 years
  • ECOG performance status 0-2
  • Histologically confirmed adenocarcinoma of the stomach (T3-4N0-3M0)
  • Negative peritoneal cytology from diagnostic laparoscopy
  • No prior chemotherapy or radiotherapy

排除标准

  • Presence of distant metastases
  • Positive peritoneal cytology
  • Previous cancer treatment (chemotherapy, radiotherapy, or surgery)
  • Severe comorbid conditions contraindicating surgery or chemotherapy
  • Pregnancy or lactation
  • Known hypersensitivity to study drugs

结局指标

主要结局

Incidence of peritoneal carcinomatosis

时间窗: 12, 24 months after surgery

Incidence of Peritoneal Carcinomatosis refers to the frequency or rate at which new cases of peritoneal carcinomatosis are diagnosed within a specific population over a defined period.

次要结局

  • Overall survival(1. 3, 5 years after surgery)
  • Disease-free survival(3, 6, 9, 12, 18, 24 months after surgery)
  • Quality of life by EORTC QLQ-C30(before surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery)
  • Frequency of adverse events(through study completion, 30 days after surgery, 90 days after surgery)

研究者

发起方
National Research Oncology and Transplantology Center, Kazakhstan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Altay Kerimkulov, MD

Principal investigator

National Research Oncology and Transplantology Center, Kazakhstan

研究点 (2)

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