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RecruitingNCT07313579G-PECUpdated Jan 13, 2026

Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer

An observational study in Gastric Cancer (GC), HIPEC and Peritoneal Metastases From Gastric Cancer, sponsored by Ukrainian Society of Clinical Oncology. Recruiting at 1 site in Ukraine. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-13.

Sponsored by Ukrainian Society of Clinical Oncology · Observational

From the registry’s dates

  • Started Dec 2025; still recruiting 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 80 Years
Sex
All
01

Study 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 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).

02

Conditions studied

  • 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
  • Stomach Diseases
  • Stomach Neoplasms
  • Chemotherapy, Adjuvant
  • Combined Modality Therapy
  • Drug Therapy
  • Surgical Procedures
03

In context

Stomach Neoplasms

3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.

This study's planned enrollment of 200 is below the median of 278 across 790 observational studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Ukrainian Society of Clinical Oncology is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 18-80
  2. Hystologicaly proven gastric adenocarcinoma
  3. status 0-1
  4. Written consent to participate in the study
  5. Medically and technically operable gastric tumor
  6. Only T4a or T4b tumours with any peritoneal cytology status
  7. Cytologically positive peritoneal washings (cyt+) with any T and N criteria
  8. Adequate haemopoetic, renal and hepatic function ( > 120, > 150*10\^9/l, \< 60, AST \<40, total \< 21 µmol/l, (male - 90-140, female - 80-130 ml/min)

Exclusion criteria

Exclusion Criteria:

  1. Pregnancy/breastfeeding
  2. status 2-4
  3. Concomitant
  4. Mitomycin and/or Cisplatin
  5. Uncontrollable chronic diseases
  6. Patients with coexisting malignancy other than basal cell carcinoma of the skin within the last five years.
  7. Presence of other than regional or peritoneal (such as liver, lungs, bone, brain, distant lymph nodes)
  8. History of allergic reactions associated with cisplatin and Mitomycin C
  9. Patients with psychiatric illness/social situations with impaired compliance
  10. •Refusal to participate
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Prophylactic cohort (T4a/T4b/cyt+)

    The cohort consists of individuals undergoing gastrectomy along with HIPEC.

    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

    Procedure: curative-intent surgery + HIPEC

Interventions

  • Procedurecurative-intent surgery + HIPEC

    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

06

What researchers measure

Primary outcomes

  1. Peritoneal recurrence rate

    Number of patients developed peritoneal recurence

    Time frame: From enrolment up to 5 years of follow-up

Secondary outcomes

  1. Distant recurrence rate

    Time from diagnosis to distant reccurence

    Time frame: Time from diagnosis up to 5 years of follow-up

  2. Intraperitoneal chemotherapy complications rate

    Complications rate assessed by Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 (Grade from 1 to 5)

    Time frame: 30 days after chemotherapy

  3. Postoperative complications rate

    Complications rate assessed by Clavien-Dindo scale (Grade from 1 to 5)

    Time frame: 30 days after surgery

  4. 5-years overall survival

    5-years overall survival

    Time frame: From the time of diagnosis up to 5 years of follow-up

  5. 5-years relapse-free survival rate

    5-years relapse-free survival rate

    Time frame: Time from diagnosis up to 5 years of follow-up

  6. 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)

    Time frame: 6 months after treatment completion

  7. 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)

    Time frame: 6 months after treatment completion

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07313579
Lead sponsor
Ukrainian Society of Clinical Oncology
Responsible party
Oleksii Dobrzhanskiy (Physician, Ukrainian Society of Clinical Oncology) — Principal investigator
First posted
Jan 2, 2026
Start date
Dec 1, 2025
Primary completion
Dec 1, 2030 (estimated)
Completion
Dec 1, 2035 (estimated)
Last update
Jan 13, 2026

Study contacts

Oleksiy Dobrzhanskyi, MD
Contact
alekseydobrzhanskiy@gmail.com
+380638760185

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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