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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06784765
Enrollment
160
Registered
2025-01-20
Start date
2025-01-15
Completion date
2027-12-01
Last updated
2025-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

Gastric Cancer, peritoneal carcinomatosis, gastrectomy, PIPAC, FLOT

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.

Detailed description

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.

Interventions

PROCEDUREIntervention Group

Preventive pressurized intraperitoneal aerosol chemotherapy (PIPAC) with cisplatin (10 mg/m2) and doxorubicin (2.1 mg/m2) + perioperative chemotherapy (FLOT regimen) +gastrectomy with D2 lymphadenectomy

PROCEDUREControl Group

Retrospective cohort receiving standard perioperative chemotherapy (FLOT regimen) + gastrectomy with D2 lymphadenectomy

Sponsors

Ministry of Science and Higher Education of the Republic of Kazakhstan
CollaboratorOTHER_GOV
National Research Oncology and Transplantology Center, Kazakhstan
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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: 1. Signed informed consent 2. Aged 18-70 years 3. ECOG performance status 0-2 4. Histologically confirmed adenocarcinoma of the stomach (T3-4N0-3M0) 5. Negative peritoneal cytology from diagnostic laparoscopy 6. No prior chemotherapy or radiotherapy

Exclusion criteria

1. Presence of distant metastases 2. Positive peritoneal cytology 3. Previous cancer treatment (chemotherapy, radiotherapy, or surgery) 4. Severe comorbid conditions contraindicating surgery or chemotherapy 5. Pregnancy or lactation 6. Known hypersensitivity to study drugs

Design outcomes

Primary

MeasureTime frameDescription
Incidence of peritoneal carcinomatosis12, 24 months after surgeryIncidence 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.

Secondary

MeasureTime frameDescription
Overall survival1. 3, 5 years after surgeryOverall Survival (OS) refers to the length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients are still alive.
Disease-free survival3, 6, 9, 12, 18, 24 months after surgeryDisease-Free Survival (DFS) is the period of time after treatment during which a patient shows no signs of the disease.
Quality of life by EORTC QLQ-C30before surgery, 3 months after surgery, 6 months after surgery, 12 months after surgeryQuality of life (assessed using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), which is calculated in points)
Frequency of adverse eventsthrough study completion, 30 days after surgery, 90 days after surgeryFrequency of Adverse Events (graded by CTCAE v5.0) refers to the rate or proportion of patients experiencing side effects or complications associated with a treatment, categorized according to severity using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Countries

Kazakhstan

Contacts

Primary ContactAltay Kerimkulov, MD
altay.kerimkulov@gmail.com+77014382825

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026