Spray chemo shows promise for stomach cancer spread
NCT ID NCT06313801
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares standard chemotherapy alone versus chemotherapy plus a special procedure called PIPAC (pressurized intraperitoneal aerosol chemotherapy) for people with stomach cancer that has spread to the lining of the abdomen. About 106 adults aged 18-75 will take part. The goal is to see if adding PIPAC helps control the cancer longer and with fewer side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 106 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2023
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Availability of signed informed voluntary consent of the patient 2. Age ≥18 years and ≤75 years 3. ECOG ≤1 4. Histological verification of gastric cancer and esophageal-gastric junction Siewert III (adenocarcinoma, ring-cell carcinoma) 5. Her2-neu negative tumor status 6. The presence of a preserved informative block of the primary tumor in the histological archive of the NOCOD (performing a biopsy and/or providing archival material - with the consent of the patient) 7. Verified gastric cancer (adenocarcinoma, ring-cell carcinoma) with the presence of M1 (with the only manifestation of M1 in the form of - Cy+ in initial peritoneal lavage and/or peritoneal dissemination PCI \<16) 8. Peritoneal adhesion index PAI \<16 9. Absence of active infectious, mental diseases, pronounced allergic conditions, as well as other concomitant pathology that may interfere with the implementation of the therapeutic and diagnostic measures provided for in the protocol 10. Adequate organ function (evaluation by laboratory parameters at screening - evaluation of hemoglobin, neutrophils, platelets, AST, ALT, total bilirubin, urea, creatinine) 11. Consent of men and women with preserved childbearing potential to use highly effective methods of contraception. Exclusion Criteria: 1. Lack of informed voluntary consent of the patient 2. Age \<18 years and \>75 years 3. ECOG ≥2 4. Histological forms other than adenocarcinoma and ring-cell carcinoma of the stomach and esophageal-gastric junction Siewert III 5. Her2-neu positive tumor status 6. The absence of a preserved informative block of the primary tumor in the histological archive of the NOCOD 7. M1 with the exception of Cy+ in initial peritoneal lavage and/or peritoneal dissemination PCI \<16 (Distant metastases, including mts in supraclavicular, mediastinal, paraaortic (16 collector), ovarian metastases. Note - MTS in peripheral lymph nodes require a fine needle puncture with cytological examination for verification. In case of mts lesions of intracorporeal lymph nodes, the criteria of mts will be - dimensions of more than 15 mm along the short axis or mts-altered structure of the lymph node, regardless of size; PCI ≥16) 8. Peritoneal adhesion index PAI ≥16 9. Contraindications to performing diagnostic laparoscopy 10. Complicated primary tumor (bleeding, decompensated stenosis, dysphagia III-IV) if not corrected. 11. Decompensated concomitant pathology 12. Primary multiple tumors (except basal cell skin cancer and cervical cancer in situ - provided there are no signs of relapse of the disease) 13. Any specific antitumor treatment for stomach cancer and /or other malignant tumor in the anamnesis (except basal cell skin cancer and cervical cancer in situ - provided there are no signs of relapse of the disease) 14. Previous specialized treatment for stomach cancer 15. Known individual intolerance to drugs included in the protocol 16. Pregnancy, breast-feeding
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Research Institute of Clinical Oncology "Nizhny Novgorod Regional Clinical Oncological Dispensary", 11/1, Delovaya street, Nizhny Novgorod, 603126
RECRUITINGNizhny Novgorod, 603126, Russia
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