Gastric Cancer (GC)G-PECNCT07313579
Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer
An observational study of Gastric Cancer (GC) and HIPEC, run by Ukrainian Society of Clinical Oncology at 1 site in Ukraine.
Trial summary
The study investigates the outcomes of hyperthermic intraperitoneal chemoperfusion (HIPEC) in combination with curative-intent gastrectomy in resectable locally-advanced and limited-metastatic (low peritoneal cancer index) gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer (GC), HIPEC, Peritoneal Metastases From Gastric Cancer
- What is being tested?
- curative-intent surgery + HIPEC
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteUkraine
- Study dates
- 1 Dec 2025to 1 Dec 2035
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adult patients receiving care at oncological centers in Ukraine who meet all predefined eligibility criteria for this study. Investigators include individuals with for which Gastrectomy+HIPEC is considered an accepted or potentially beneficial treatment option according to national and international clinical guidelines. Participants will be recruited from tertiary surgical oncology hospitals and specialized cancer institutes across Ukraine.
Who may be able to join
- Age 18-80
- Hystologicaly proven gastric adenocarcinoma
- ECOG status 0-1
- Written consent to participate in the study
- Medically and technically operable gastric tumor
- Only T4a or T4b tumours with any peritoneal cytology status
- Cytologically positive peritoneal washings (cyt+) with any T and N criteria
- Adequate haemopoetic, renal and hepatic function (Hb > 120, PLT > 150*10^9/l, ALT < 60, AST <40, total bilirubin < 21 µmol/l, Creatinine clearance (male - 90-140, female - 80-130 ml/min)
Who cannot join
- Pregnancy/breastfeeding
- ECOG status 2-4
- Concomitant malignancy
- Mitomycin and/or Cisplatin hypersensitivity
- Uncontrollable chronic diseases
- Patients with coexisting malignancy other than basal cell carcinoma of the skin within the last five years.
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- Presence of metastases other than regional or peritoneal (such as liver, lungs, bone, brain, distant lymph nodes)
- History of allergic reactions associated with cisplatin and Mitomycin C
- Patients with psychiatric illness/social situations with impaired compliance
- •Refusal to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ukraine1 site, 1 recruiting
- Recruiting
National Cancer Institute (NCI)
Kyiv
Oleksiy Dobrzhanskyi, MD, +380638760185, alekseydobrzhanskiy@gmail.com
Oleksiy Dobrzhanskyi, MD, alekseydobrzhanskiy@gmail.com
About this study
Official title: Observational Prospective Cohort Study on Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer
The study investigates the outcomes of hyperthermic intraperitoneal chemoperfusion (HIPEC) in combination with curative-intent gastrectomy in resectable locally-advanced and limited-metastatic (low peritoneal cancer index) gastric cancer.
Read the detailed description
Several recent studies showed that near-perfect curative-intent R0 surgical technique combined with systemic chemotherapy or even immunotherapy may not always be enough to eliminate microscopic deposits or eliminate peritoneal dissemination in locally advanced gastric cancer or low peritoneal cancer-index (PCI) tumors. The risk of peritoneal dissemination is especially high for T4 tumors, for those with cytologically positive peritoneal washings. Moreover, the risk of peritoneal relapse in low PCI tumors is remarkably high. Combination of surgery and intraperitoneal chemotherapy aims to minimise the risks of the aforementioned peritoneal progression. In the study investigators perform curative surgery followed by single dose of hyperthermic intraperitoneal chemotherapy (HIPEC).
- Conditions
- Gastric Cancer (GC), HIPEC, Peritoneal Metastases From Gastric Cancer, Hyperthermic Intraperitoneal Chemoperfusion
- Being tested
- curative-intent surgery + HIPEC
- Keywords
- Gastric cancer, HIPEC, Hyperthermic Intraperitoneal Chemoperfusion, FLOT, Lymphadenectomy, Gastrointestinal Neoplasms, Digestive System Neoplasms, Gastrointestinal Diseases, Stomach Diseases, Stomach Neoplasms, Chemotherapy, Adjuvant, Combined Modality Therapy, Drug Therapy, Surgical Procedures
- Medical subject headings
- Stomach Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Gastrointestinal Diseases, Stomach Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
curative-intent surgery + HIPECProcedure or surgery
Participants enrolled in this study will undergo curative-intent gastrectomy for gastric cancer, immediately followed by Hyperthermic Intraperitoneal Chemotherapy (HIPEC) performed during the same operative session. Dosage of drugs: mitomycin C 15 mg/m2, cisplatin 75mg/m2. The procedure is conducted according to a standardized protocol in National Cancer Institute
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic cohort (T4a/T4b/cyt+) | The cohort consists of individuals undergoing gastrectomy along with HIPEC. Receives: Procedure: curative-intent surgery + HIPEC | |
| Low PCI cohort (PCI<7) | Patients with low PCI undergo curative surgery with cytoreduction of visually detected peritoneal nodules followed by HIPEC Receives: Procedure: curative-intent surgery + HIPEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peritoneal recurrence rate
Number of patients developed peritoneal recurence
Measured: From enrolment up to 5 years of follow-up
Secondary outcomes (7)
Distant recurrence rate
Time from diagnosis to distant reccurence
Measured: Time from diagnosis up to 5 years of follow-up
Intraperitoneal chemotherapy complications rate
Complications rate assessed by Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 (Grade from 1 to 5)
Measured: 30 days after chemotherapy
Postoperative complications rate
Complications rate assessed by Clavien-Dindo scale (Grade from 1 to 5)
Measured: 30 days after surgery
5-years overall survival
5-years overall survival
Measured: From the time of diagnosis up to 5 years of follow-up
5-years relapse-free survival rate
5-years relapse-free survival rate
Measured: Time from diagnosis up to 5 years of follow-up
Treatment-related quality of life assessed by Quality Of Life Questionnaire C30 version 3.0
Treatment-related quality of life assessed by Quality Of Life Questionnaire C30 version 3.0 (lower score means better outcomes, higher score means worse outcomes)
Measured: 6 months after treatment completion
Treatment-related quality of life assessed by Quality of Life Questionnaire-Stomach
Treatment-related quality of life assessed by Quality of Life Questionnaire-Stomach (lower score means better outcomes, higher score means worse outcomes)
Measured: 6 months after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start1 Dec 2025
- Primary completion1 Dec 2030 (estimated)
- Study completion1 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer (GC)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ukrainian Society of Clinical Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oleksii Dobrzhanskiy, Ukrainian Society of Clinical Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313579
- Sponsor's protocol ID
- 24999/2025
- Acronym
- G-PEC
- Status last verified
- Jan 2026
- First submitted
- 8 Dec 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Prospective Cohort Study on Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer
- ClinicalTrials.gov ID
- NCT07313579
- Acronym / sponsor ID
- G-PEC / 24999/2025
- Conditions
- Gastric Cancer (GC), HIPEC, Peritoneal Metastases From Gastric Cancer, Hyperthermic Intraperitoneal Chemoperfusion
- Keywords
- Gastric cancer, HIPEC, Hyperthermic Intraperitoneal Chemoperfusion, FLOT, Lymphadenectomy, Gastrointestinal Neoplasms, Digestive System Neoplasms, Gastrointestinal Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ukrainian Society of Clinical OncologyUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Dec 2030 (estimated)
- Study completion
- 1 Dec 2035 (estimated)
- First posted
- 2 Jan 2026 (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.
The study investigates the outcomes of hyperthermic intraperitoneal chemoperfusion (HIPEC) in combination with curative-intent gastrectomy in resectable locally-advanced and limited-metastatic (low peritoneal cancer index) gastric cancer.
Detailed description
Several recent studies showed that near-perfect curative-intent R0 surgical technique combined with systemic chemotherapy or even immunotherapy may not always be enough to eliminate microscopic deposits or eliminate peritoneal dissemination in locally advanced gastric cancer or low peritoneal cancer-index (PCI) tumors. The risk of peritoneal dissemination is especially high for T4 tumors, for those with cytologically positive peritoneal washings. Moreover, the risk of peritoneal relapse in low PCI tumors is remarkably high. Combination of surgery and intraperitoneal chemotherapy aims to minimise the risks of the aforementioned peritoneal progression. In the study investigators perform curative surgery followed by single dose of hyperthermic intraperitoneal chemotherapy (HIPEC).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylactic cohort (T4a/T4b/cyt+) | – | Procedure: curative-intent surgery + HIPECThe cohort consists of individuals undergoing gastrectomy along with HIPEC. |
| Low PCI cohort (PCI<7) | – | Procedure: curative-intent surgery + HIPECPatients with low PCI undergo curative surgery with cytoreduction of visually detected peritoneal nodules followed by HIPEC |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients receiving care at oncological centers in Ukraine who meet all predefined eligibility criteria for this study. Investigators include individuals with for which Gastrectomy+HIPEC is considered an accepted or potentially beneficial treatment option according to national and international clinical guidelines. Participants will be recruited from tertiary surgical oncology hospitals and specialized cancer institutes across Ukraine.
Key inclusion criteria (8 listed)
- Age 18-80
- Hystologicaly proven gastric adenocarcinoma
- ECOG status 0-1
- Written consent to participate in the study
- Medically and technically operable gastric tumor
Key exclusion criteria (10 listed)
- Pregnancy/breastfeeding
- ECOG status 2-4
- Concomitant malignancy
- Mitomycin and/or Cisplatin hypersensitivity
- Uncontrollable chronic diseases
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 |
|---|---|---|
| curative-intent surgery + HIPECParticipants enrolled in this study will undergo curative-intent gastrectomy for gastric cancer, immediately followed by Hyperthermic Intraperitoneal Chemotherapy (HIPEC) performed during the same operative session. Dosage of drugs: mitomycin C 15 mg/m2, cisplatin 75mg/m2. The procedure is conducted according to a standardized protocol in National Cancer Institute | Procedure or surgery | Low PCI cohort (PCI<7), Prophylactic cohort (T4a/T4b/cyt+) |
Primary outcome
Peritoneal recurrence rate
Time frame: From enrolment up to 5 years of follow-up
Number of patients developed peritoneal recurence
7 secondary outcomes
Distant recurrence rate
Time frame: Time from diagnosis up to 5 years of follow-up
Intraperitoneal chemotherapy complications rate
Time frame: 30 days after chemotherapy
Postoperative complications rate
Time frame: 30 days after surgery
5-years overall survival
Time frame: From the time of diagnosis up to 5 years of follow-up
5-years relapse-free survival rate
Time frame: Time from diagnosis up to 5 years of follow-up
Treatment-related quality of life assessed by Quality Of Life Questionnaire C30 version 3.0
Time frame: 6 months after treatment completion
Treatment-related quality of life assessed by Quality of Life Questionnaire-Stomach
Time frame: 6 months after treatment completion
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 13 Jan 2026.
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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?
An observational study of Gastric Cancer (GC) and HIPEC, run by Ukrainian Society of Clinical Oncology at 1 site in Ukraine.
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 8 inclusion and 10 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 13 Jan 2026. 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 Ukraine. 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 Oleksiy Dobrzhanskyi, MD (+380638760185, alekseydobrzhanskiy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peritoneal recurrence rate (time frame: From enrolment up to 5 years of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2026.