New way to deliver chemo may boost survival in stomach cancer patients
NCT ID NCT07304271
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 262 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Jan 2031
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- 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: * 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.
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The places running it
7 sites in 3 countries. 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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Amsterdam University Medical Center
NOT_YET_RECRUITINGAmsterdam, 1081, Netherlands
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Azienda Ospedaliera Universitaria Integrata Verona
NOT_YET_RECRUITINGVerona, 37126, Italy
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Karolinska University Hospital
RECRUITINGStockholm, 171 76, Sweden
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Sahlgrenska University Hospital
NOT_YET_RECRUITINGGothenburg, 413 46, Sweden
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Skane University Hospital
NOT_YET_RECRUITINGLund, SE-222 42, Sweden
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Uppsala University Hospital
RECRUITINGUppsala, SE-751 85, Sweden
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Örebro University Hospital
NOT_YET_RECRUITINGÖrebro, SE-701 85, Sweden
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