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NCT06784765Recruiting

Preventive Use of PIPAC in Locally Advanced Gastric Cancer.

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

Source: ClinicalTrials.gov · Last updated 9 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
160 (estimated)
First submitted
31 Dec 2024
Start date
15 Jan 2025
Primary completion date
30 Dec 2026
Lead sponsor
National Research Oncology and Transplantology Center, Kazakhstan
NCT number
NCT06784765

What you commit to

  • Study type: Interventional
  • Planned participants: 160
  • From 15 Jan 2025 to the primary completion date, 30 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Previous cancer treatment (chemotherapy, radiotherapy, or surgery)
  • Severe comorbid conditions contraindicating surgery or chemotherapy
  • Known hypersensitivity to study drugs

Other

  • Presence of distant metastases
  • Positive peritoneal cytology
  • Pregnancy or lactation

Who the study is looking for

  • 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

Criteria the registry did not label

  • Adults aged 18-70 years with histologically confirmed locally advanced gastric adenocarcinoma (T3-4N0-3M0), ECOG performance status 0-2, and negative peritoneal cytology.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
National Research Oncology Centre
Coordinator of this site? Confirm its status
AstanaKazakhstanRecruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.