Gastric CancerNCT06784765
Preventive Use of PIPAC in Locally Advanced Gastric Cancer.
A study testing Intervention Group in people with Gastric Cancer, run by National Research Oncology and Transplantology Center, Kazakhstan at 1 site in Kazakhstan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Intervention Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteKazakhstan
- Study dates
- 15 Jan 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Presence of distant metastases
- Positive peritoneal cytology
- Previous cancer treatment (chemotherapy, radiotherapy, or surgery)
- Severe comorbid conditions contraindicating surgery or chemotherapy
- Pregnancy or lactation
- Known hypersensitivity to study drugs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kazakhstan1 site, 1 recruiting
- Recruiting
National Research Oncology Centre
Astana, 010000
Altay Kerimkulov, MD, +77014382825, altay.kerimkulov@gmail.com
About this study
Official title: 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.
Read the 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
- Being tested
- Intervention Group, Control Group
- Keywords
- Gastric Cancer, peritoneal carcinomatosis, gastrectomy, PIPAC, FLOT
- Medical subject headings
- Stomach Neoplasms, Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupProcedure or surgery
Also called doxorubicin (2.1 mg/m2), cisplatin (10 mg/m2), perioperative chemotherapy (FLOT regimen), gastrectomy
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
Control GroupProcedure or surgery
Also called standard perioperative chemotherapy (FLOT regimen), gastrectomy, D2 lymphadenectomy
Retrospective cohort receiving standard perioperative chemotherapy (FLOT regimen) + gastrectomy with D2 lymphadenectomy
| Study group | Role | What they receive |
|---|---|---|
| PIPAC+FLOT | Experimental | ◦ 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. Receives: Procedure: Intervention Group |
| FLOT | Active comparator | Retrospective cohort receiving standard perioperative chemotherapy (FLOT regimen) + gastrectomy with D2 D2 lymphadenectomy. Receives: Procedure: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of peritoneal carcinomatosis
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.
Measured: 12, 24 months after surgery
Secondary outcomes (4)
Overall survival
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.
Measured: 1. 3, 5 years after surgery
Disease-free survival
Disease-Free Survival (DFS) is the period of time after treatment during which a patient shows no signs of the disease.
Measured: 3, 6, 9, 12, 18, 24 months after surgery
Quality of life by EORTC QLQ-C30
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)
Measured: before surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
Frequency of adverse events
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.
Measured: through study completion, 30 days after surgery, 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start15 Jan 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Oncology and Transplantology Center, Kazakhstan
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Higher Education of the Republic of Kazakhstan
- Responsible party
- Principal investigator, Altay Kerimkulov, MD, National Research Oncology and Transplantology Center, Kazakhstan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06784765
- Sponsor's protocol ID
- KAZNEOPAC
- Other IDs
- BR24992950
- Status last verified
- Dec 2024
- First submitted
- 31 Dec 2024
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35602919Coccolini F, Nardi M, Montori G, Ceresoli M, Celotti A, Cascinu S, Fugazzola P, Tomasoni M, Glehen O, Catena F, Yonemura Y, Ansaloni L. Neoadjuvant chemotherapy in advanced gastric and esophago-gastric cancer. Meta-analysis of randomized trials. Int J Surg. 2018 Mar;51:120-127. doi: 10.1016/j.ijsu.2018.01.008. Epub 2018 Feb 20.
PubMed 29413875Al-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.
PubMed 28501086Macdonald 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.
PubMed 11547741Cotte 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.
PubMed 21160814Kerimkulov A, Uskenbayev T, Sarina T, Mamlin M, Shalekenov S, Yessenbayeva G, Kainazarov T, Burkitbayev Z, Ussipbekov B, Kovalchuk D, Rakhmankulov A, Rakhmankulova A, Gaipov A. Efficacy of Preventive Pressurized Intraperitoneal Aerosol Chemotherapy in Patients With Locally Advanced Gastric Cancer: Protocol for a Prospective Controlled Trial. JMIR Res Protoc. 2025 Nov 11;14:e78053. doi: 10.2196/78053.
PubMed 41218205
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Use of Pressurized Intraperitoneal Aerosol Chemotherapy in Locally Advanced Gastric Cancer: A Non-Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06784765
- Acronym / sponsor ID
- KAZNEOPAC
- Conditions
- Gastric Cancer
- Keywords
- Gastric Cancer, peritoneal carcinomatosis, gastrectomy, PIPAC, FLOT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- National Research Oncology and Transplantology Center, KazakhstanUniversity, hospital or other
- Collaborators
- Ministry of Science and Higher Education of the Republic of Kazakhstan
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PIPAC+FLOT | Experimental | 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 D2 lymphadenectomy. |
| FLOT | Active comparator | Procedure: Control GroupRetrospective cohort receiving standard perioperative chemotherapy (FLOT regimen) + gastrectomy with D2 D2 lymphadenectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- Presence of distant metastases
- Positive peritoneal cytology
- Previous cancer treatment (chemotherapy, radiotherapy, or surgery)
- Severe comorbid conditions contraindicating surgery or chemotherapy
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention GroupAlso: doxorubicin (2.1 mg/m2), cisplatin (10 mg/m2), perioperative chemotherapy (FLOT regimen), gastrectomyPreventive pressurized intraperitoneal aerosol chemotherapy (PIPAC) with cisplatin (10 mg/m2) and doxorubicin (2.1 mg/m2) + perioperative chemotherapy (FLOT regimen) +gastrectomy with D2 lymphadenectomy | Procedure or surgery | PIPAC+FLOT |
| Control GroupAlso: standard perioperative chemotherapy (FLOT regimen), gastrectomy, D2 lymphadenectomyRetrospective cohort receiving standard perioperative chemotherapy (FLOT regimen) + gastrectomy with D2 lymphadenectomy | Procedure or surgery | FLOT |
Primary outcome
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.
4 secondary outcomes
Overall survival
Time frame: 1. 3, 5 years after surgery
Disease-free survival
Time frame: 3, 6, 9, 12, 18, 24 months 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
Frequency of adverse events
Time frame: through study completion, 30 days after surgery, 90 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Results publication: PubMed 35602919Sgarbura 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.
- Results publication: PubMed 29413875Coccolini F, Nardi M, Montori G, Ceresoli M, Celotti A, Cascinu S, Fugazzola P, Tomasoni M, Glehen O, Catena F, Yonemura Y, Ansaloni L. Neoadjuvant chemotherapy in advanced gastric and esophago-gastric cancer. Meta-analysis of randomized trials. Int J Surg. 2018 Mar;51:120-127. doi: 10.1016/j.ijsu.2018.01.008. Epub 2018 Feb 20.
- Results publication: PubMed 28501086Al-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.
- Results publication: PubMed 11547741Macdonald 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.
- Results publication: PubMed 21160814Cotte 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.
- Derived from this study: PubMed 41218205Kerimkulov A, Uskenbayev T, Sarina T, Mamlin M, Shalekenov S, Yessenbayeva G, Kainazarov T, Burkitbayev Z, Ussipbekov B, Kovalchuk D, Rakhmankulov A, Rakhmankulova A, Gaipov A. Efficacy of Preventive Pressurized Intraperitoneal Aerosol Chemotherapy in Patients With Locally Advanced Gastric Cancer: Protocol for a Prospective Controlled Trial. JMIR Res Protoc. 2025 Nov 11;14:e78053. doi: 10.2196/78053.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Gastric Cancer, run by National Research Oncology and Transplantology Center, Kazakhstan at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Altay Kerimkulov, MD (+77014382825, altay.kerimkulov@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of peritoneal carcinomatosis (time frame: 12, 24 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06784765, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.