Preventive Use of PIPAC in Locally Advanced Gastric Cancer.

May 6, 2025 updated by: Altay Kerimkulov, MD, National Research Oncology and Transplantology Center, Kazakhstan

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PIPAC+FLOT
◦ Preventive pressurized intraperitoneal aerosol chemotherapy (PIPAC) with cisplatin (10 mg/m2) and doxorubicin (2.1 mg/m2) + perioperative chemotherapy (FLOT regimen) + gastrectomy with D2 D2 lymphadenectomy.
Procedure: Intervention 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
Other Names:
  • D2 lymphadenectomy
  • gastrectomy
  • doxorubicin (2.1 mg/m2)
  • cisplatin (10 mg/m2)
  • perioperative chemotherapy (FLOT regimen)
  • Preventive pressurized intraperitoneal aerosol chemotherapy (PIPAC)
Active Comparator: FLOT
Retrospective cohort receiving standard perioperative chemotherapy (FLOT regimen) + gastrectomy with D2 D2 lymphadenectomy.
Procedure: Control Group
Retrospective cohort receiving standard perioperative chemotherapy (FLOT regimen) + gastrectomy with D2 lymphadenectomy
Other Names:
  • D2 lymphadenectomy
  • gastrectomy
  • standard perioperative chemotherapy (FLOT regimen)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of peritoneal carcinomatosis
Time Frame: 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.
12, 24 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 1. 3, 5 years after surgery
Overall 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.
1. 3, 5 years after surgery
Disease-free survival
Time Frame: 3, 6, 9, 12, 18, 24 months after surgery
Disease-Free Survival (DFS) is the period of time after treatment during which a patient shows no signs of the disease.
3, 6, 9, 12, 18, 24 months after surgery
Frequency of adverse events
Time Frame: through study completion, 30 days after surgery, 90 days after surgery
Frequency 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.
through study completion, 30 days after surgery, 90 days after surgery
Quality of life by EORTC QLQ-C30
Time Frame: before surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
Quality of life (assessed using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), which is calculated in points)
before surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Research Oncology and Transplantology Center, Kazakhstan

Collaborators

Ministry of Science and Higher Education of the Republic of Kazakhstan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

December 31, 2024

First Submitted That Met QC Criteria

January 15, 2025

First Posted (Actual)

January 20, 2025

Study Record Updates

Last Update Posted (Actual)

May 9, 2025

Last Update Submitted That Met QC Criteria

May 6, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAZNEOPAC
  • BR24992950 (Other Grant/Funding Number: Committee of Science of the Ministry of Science and Higher Education of the Republic of Kazakhstan)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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