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Evaluating intraperitoneal irinotecan with systemic therapy in patients with gastric peritoneal metastases

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on treating patients with gastric peritoneal metastases, a condition where cancer from the stomach has spread to the lining of the abdominal cavity. The study evaluates a treatment combining irinotecan, a cancer medication, given directly into the abdominal cavity (through a procedure called intraperitoneal administration) along with other standard cancer treatments given through the bloodstream.

The purpose of the study is to determine if it is possible to safely give irinotecan directly into the abdominal cavity while patients are receiving their regular cancer treatment. The study will last approximately 18 months for each participant. During this time, patients will receive multiple treatment cycles combining intraperitoneal irinotecan with their standard cancer therapy.

The medication being tested, irinotecan, belongs to a group of drugs called DNA topoisomerase I inhibitors, which work by interfering with cancer cell growth. The treatment will be given at doses up to 75 milligrams per day, with a maximum total dose of 600 milligrams over the course of treatment. Researchers will monitor how well patients tolerate the treatment and track their progress throughout the study period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment preparation

    After confirmation of gastric cancer or gastroesophageal junction cancer with spread to the peritoneum (the lining of the abdominal cavity), your treatment plan will be established.

    Your doctor will evaluate your overall health status and confirm you have a good performance status (ability to carry out daily activities).

  2. Step 2

    Treatment administration

    You will receive a combination of two types of treatment:

    - Intraperitoneal irinotecan: medication delivered directly into the abdominal cavity

    - Systemic therapy: standard cancer treatment given through the bloodstream

    The treatment will be administered in cycles (specific schedule to be determined by your healthcare team)

  3. Step 3

    Monitoring during treatment

    Regular medical evaluations will track your response to treatment

    You will complete quality of life questionnaires at several points: before starting treatment, after the first cycle, after the first imaging evaluation, and after the last cycle

    Your doctor will monitor for any side effects or complications throughout the treatment period

  4. Step 4

    Response evaluation

    Your response to treatment will be assessed through regular imaging tests

    The medical team will evaluate how well the cancer is responding to the combination therapy

    Treatment effectiveness will be measured by checking if the cancer has grown, shrunk, or remained stable

  5. Step 5

    Follow-up period

    After completing treatment, you will have regular follow-up appointments to monitor your health status

    The medical team will continue to track your progress and any long-term effects of the treatment

    The total follow-up period will continue until at least 2028

Who can join the trial?

6 criteria

  • You must be 18 years or older
  • You must have confirmed gastric cancer (stomach cancer) or gastroesophageal junction adenocarcinoma (cancer where the esophagus meets the stomach) confirmed through tissue examination
  • You must have peritoneal metastases (cancer spread to the lining of the abdominal cavity) confirmed by both physical examination and pathology tests, with a PCI score (a measure of how far the cancer has spread in the abdomen) of 1 or higher
  • Your physical condition must meet WHO performance score of 0 to 1 (meaning you must be able to perform all or most daily activities on your own) and have a life expectancy of at least three months
  • You must be able to provide written informed consent, showing you understand and agree to participate in the study
  • Both men and women can participate in this study

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Presence of cancer that has spread beyond the peritoneal cavity (the space that contains abdominal organs)
  • Previous allergic reactions to irinotecan or other chemotherapy medications
  • Severe heart disease or significant heart problems
  • Severe liver problems or abnormal liver function
  • Severe kidney problems or abnormal kidney function
  • Active infections requiring treatment
  • Pregnancy or breastfeeding
  • Blood disorders that significantly affect blood cell counts
  • Previous major abdominal surgery within the last 4 weeks
  • Participation in other clinical trials within the last 30 days
  • Inability to understand or sign informed consent
  • Mental conditions that prevent following study procedures
  • Bowel obstruction (blockage in intestines)
  • Uncontrolled high blood pressure
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Investigated drugs

  • Irinotecan

    is a chemotherapy medication used to treat cancer. In this trial, it is administered in two ways: directly into the peritoneal cavity (the space in your abdomen that contains organs) and through the bloodstream (systemic therapy). This medication works by interfering with cancer cell growth and division, helping to fight gastric cancer that has spread to the peritoneal area.

  • Systemic therapy

    refers to cancer treatment medications that travel through the bloodstream to reach cancer cells throughout the body. This approach is combined with the intraperitoneal treatment to provide comprehensive cancer treatment.

What is already known about the treatment

Irinotecan – A chemotherapy medication administered both intraperitoneally (directly into the abdominal cavity) and systemically (through the bloodstream) for treating gastric cancer with peritoneal metastases. This topoisomerase I inhibitor works by interfering with cancer cell DNA replication, preventing tumor cells from dividing and growing. It belongs to the pharmacological class of plant alkaloids and specifically to the camptothecin derivatives family, and is currently well-established in medical literature as an effective treatment option for various gastrointestinal cancers. The medication's dual administration method (intraperitoneal and systemic) allows for both direct contact with cancer cells in the peritoneal cavity and systemic distribution throughout the body.

Investigated diseases

Gastric Peritoneal Metastasis - A condition that occurs when cancer cells from stomach cancer spread to the peritoneum, which is the lining of the abdominal cavity. It develops when cancer cells break away from the original stomach tumor and implant themselves on the peritoneal surface. These cancer cells then grow and form new tumors throughout the peritoneal cavity. The condition typically causes fluid accumulation in the abdomen and can affect multiple organs within the abdominal cavity. The spread of cancer cells can occur through direct extension from the stomach or through the circulation of cancer cells in the peritoneal fluid.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521468-36-00Estimated enrolment49 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

sourced from the EU Clinical Trials Register and site verification

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