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Studies

Interventional Recruiting

NCT06784765 on ClinicalTrials.gov

Preventive Use of PIPAC in Locally Advanced Gastric Cancer.

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

  • Sponsor: Ministry of Education and Science of the Republic of Kazakhstan
  • Collaborators: Ministry of Science and Higher Education of the Republic of Kazakhstan
  • Enrollment: 160 (Estimated)
  • Study start: 2025-01-15 (Actual)
  • Primary completion: 2026-12-30 (Estimated)
  • Study completion: 2027-12-01 (Estimated)
  • Allocation: Non-Randomized
  • InterventionModel: Parallel
  • Masking: None
  • PrimaryPurpose: Prevention

Brief Summary

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.

Conditions

  • Gastric Cancer

Intervention / Treatment

  • Procedure: Intervention Group
  • Procedure: Control Group

Primary Outcome Measures

  • Incidence of peritoneal carcinomatosis (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.

Countries

Kazakhstan

Locations and Investigators

  • National Research Oncology Centre, Astana, Kazakhstan (Recruiting)
    • Altay Kerimkulov, MD