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Aerosol chemo shows promise for Hard-to-Treat stomach cancer

NCT ID NCT05644249

Disease control Sponsor: Vilnius University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a new treatment for stomach cancer that has spread to the lining of the abdomen. The approach combines standard chemotherapy with a procedure called PIPAC, which delivers chemotherapy as a pressurized aerosol directly into the abdomen during a keyhole surgery. The study included 37 patients and aimed to see if this combination is feasible and safe as a first-line treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pressurized intraperitoneal aerosol chemotherapy (PIPAC) with cisplatin and doxorubicin, plus systemic FOLFOX chemotherapy
What this could lead to
If this approach proves effective, it could offer a new first-line treatment option for gastric cancer that has spread to the lining of the abdomen, potentially improving outcomes.
What could go wrong
This was a small, early feasibility study with only 37 participants and no comparison group. The results may not apply to all patients, and the combination treatment carries risks from both chemotherapy and the PIPAC procedure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

37 people

The number who actually took part.

Started

Dec 2022

Finished

Sep 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histologically verified gastric adenocarcinoma (HER2 negative) with peritoneal carcinomatosis; 2. Age≥18; 3. ECOG≤1; 4. Patient willing to participate; 5. Patient is the candidate for 1st line FOLFOX palliative systemic chemotherapy. Exclusion Criteria: 1. Extra-abdominal metastases; 2. Siewert I type gastroesophageal junction cancer; 3. Mechanical bowel obstruction; 4. Allergy to study drugs; 5. History of previous intraperitoneal chemotherapy; 6. Pregnancy of refusal for birth-control at least 6 months post-study treatment

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Conditions

The condition(s) this trial relates to.

gastric cancer gastric neoplasm peritoneal carcinomatosis peritoneal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastric cancer Peritoneal carcinomatosis

Contacts and locations

Locations

  • Nationa Cancer Institute

    Vilnius, Vilniaus, 08406, Lithuania

  • Vilnius University hospital Santaros Klinikos

    Vilnius, Vilniaus, 08661, Lithuania

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