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New way to deliver chemo may boost survival in stomach cancer patients

NCT ID NCT07304271

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times

Summary

This phase 3 trial tests whether giving chemotherapy directly into the abdomen (intraperitoneal paclitaxel) along with standard systemic therapy improves survival compared to systemic therapy alone in stomach cancer patients whose cancer has spread to the lining of the abdomen. About 262 participants will be randomly assigned to one of the two groups. The study is currently recruiting.

What this could mean

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

Active substance
Paclitaxel given directly into the abdomen (intraperitoneal)
What this could lead to
If it works, this could offer a new first-line treatment option that improves survival for gastric cancer patients with peritoneal spread.
What could go wrong
This is a phase 3 trial, but the benefit is uncertain. The added intraperitoneal treatment may cause side effects or not improve survival enough to change practice.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 262 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Jan 2031

An estimate. End dates often move.

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: * Gastric or gastro-oesophageal junction Siewert type II or III adenocarcinoma verified by biopsy or cytology from the primary tumour * Peritoneal metastasis verified by biopsy, or cytology from ascites or peritoneal wash fluid * Staging laparoscopy with assessment of peritoneal cancer index (PCI) performed less than four weeks before enrolment. * Patients with tumour positive cytology (CYT+) without clinically manifest peritoneal metastases at baseline (PCI 0) staging laparoscopy can be included if they persist to be CYT+ after at least four cycles of systemic chemotherapy. * Adequate hematology assessment and serum chemistry * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Age of at least 18 years * Life expectancy of at least three months * Assurance that adequate anti-reproductive measures will be taken during study interventions when applicable Exclusion Criteria: * Comorbidity that does not allow treatment with ST or IP paclitaxel * Confirmed or suspected severe abdominal adhesions * Severe coagulation disorder which precludes surgical interventions * Distant metastases (including M1 lymph node metastases) other than peritoneal, with the specific exception of ovarian metastases * Symptomatic ascites already requiring drainage for palliation, or expected to require drainage in the short term * Peritoneal recurrence of gastric cancer diagnosed within 6 months after curative intent surgery * Previously received more than 2 cycles of palliative-intent systemic chemotherapy (with the specific exception of cytology positive patients without manifest peritoneal metastases) for the current gastric cancer (up to 2 cycles of first line chemotherapy is allowed). Perioperative chemotherapy within previous curative context is allowed * Another malignancy that can affect survival within the next three years * Known or suspected allergies against any product included in the trial interventions * DYPD deficiency * Pregnancy or recent delivery within 28 days postpartum or ongoing breastfeeding * Active sex-life without use of secure contraceptive method. * If the investigator considers the patient inappropriate for participation in the study for any other reason * Ongoing or recent participation (within 30 days) in a clinical trial with an investigational medicinal product

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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.

  1. The places running it

    7 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Amsterdam University Medical Center

    NOT_YET_RECRUITING

    Amsterdam, 1081, Netherlands

  • Azienda Ospedaliera Universitaria Integrata Verona

    NOT_YET_RECRUITING

    Verona, 37126, Italy

  • Karolinska University Hospital

    RECRUITING

    Stockholm, 171 76, Sweden

  • Sahlgrenska University Hospital

    NOT_YET_RECRUITING

    Gothenburg, 413 46, Sweden

  • Skane University Hospital

    NOT_YET_RECRUITING

    Lund, SE-222 42, Sweden

  • Uppsala University Hospital

    RECRUITING

    Uppsala, SE-751 85, Sweden

  • Örebro University Hospital

    NOT_YET_RECRUITING

    Örebro, SE-701 85, Sweden

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