Preventive Use of PIPAC in Locally Advanced Gastric Cancer.

NCT ID: NCT06784765

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-15
• Study Completion Date: 2027-12-01

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Intervention Group

Intervention Type: PROCEDURE

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

FLOT

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

Group Type: ACTIVE_COMPARATOR

Control Group

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Control Group

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

Intervention Type: PROCEDURE

Other Intervention Names

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

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Science and Higher Education of the Republic of Kazakhstan

OTHER_GOV

Sponsor Role: collaborator

National Research Oncology and Transplantology Center, Kazakhstan

OTHER

Sponsor Role: lead

Responsible Party

Altay Kerimkulov, MD

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Research Oncology Centre

Astana, , Kazakhstan

Site Status: RECRUITING

Countries

Kazakhstan

Central Contacts

Altay Kerimkulov, MD

Role: CONTACT

altay.kerimkulov@gmail.com

+77014382825

Facility Contacts

Altay Kerimkulov, MD

Role: primary

altay.kerimkulov@gmail.com

+77014382825

References

Sgarbura O, Eveno C, Alyami M, Bakrin N, Guiral DC, Ceelen W, Delgadillo X, Dellinger T, Di Giorgio A, Kefleyesus A, Khomiakov V, Mortensen MB, Murphy J, Pocard M, Reymond M, Robella M, Rovers KP, So J, Somashekhar SP, Tempfer C, Van der Speeten K, Villeneuve L, Yong WP, Hubner M. Consensus statement for treatment protocols in pressurized intraperitoneal aerosol chemotherapy (PIPAC). Pleura Peritoneum. 2022 Mar 1;7(1):1-7. doi: 10.1515/pp-2022-0102. eCollection 2022 Mar 1.

Reference Type: BACKGROUND

PMID: 35602919 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 29413875 (View on PubMed)

Al-Batran SE, Lorenzen S. Management of Locally Advanced Gastroesophageal Cancer: Still a Multidisciplinary Global Challenge? Hematol Oncol Clin North Am. 2017 Jun;31(3):441-452. doi: 10.1016/j.hoc.2017.01.004. Epub 2017 Mar 29.

Reference Type: BACKGROUND

PMID: 28501086 (View on PubMed)

Macdonald JS, Smalley SR, Benedetti J, Hundahl SA, Estes NC, Stemmermann GN, Haller DG, Ajani JA, Gunderson LL, Jessup JM, Martenson JA. Chemoradiotherapy after surgery compared with surgery alone for adenocarcinoma of the stomach or gastroesophageal junction. N Engl J Med. 2001 Sep 6;345(10):725-30. doi: 10.1056/NEJMoa010187.

Reference Type: BACKGROUND

PMID: 11547741 (View on PubMed)

Cotte E, Passot G, Gilly FN, Glehen O. Selection of patients and staging of peritoneal surface malignancies. World J Gastrointest Oncol. 2010 Jan 15;2(1):31-5. doi: 10.4251/wjgo.v2.i1.31.

Reference Type: BACKGROUND

PMID: 21160814 (View on PubMed)

Other Identifiers

BR24992950

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

KAZNEOPAC

Identifier Type: -

Identifier Source: org_study_id