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Study of intraperitoneal paclitaxel combined with systemic therapy versus systemic therapy alone for patients with gastric cancer and 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 study focuses on treating patients with gastric cancer (cancer of the stomach) that has spread to the lining of the abdomen, known as peritoneal metastases. The research compares two different treatment approaches: one combining standard therapy with a special way of giving paclitaxel directly into the abdominal cavity (called intraperitoneal administration), and another using only standard therapy. The standard therapy may include various medications such as fluorouracil, oxaliplatin, capecitabine, docetaxel, pembrolizumab, nivolumab, zolbetuximab, and trastuzumab.

The main purpose is to determine if adding intraperitoneal paclitaxel to standard treatment helps patients live longer. During the study, patients will be randomly assigned to receive either the combination of intraperitoneal paclitaxel with standard therapy or standard therapy alone. The treatment period may continue for up to 60 months, depending on how well patients respond to the therapy.

Throughout the study, doctors will monitor patients' overall health, measure how well the treatment is working, and track any side effects that may occur. They will also assess patients' quality of life during and after treatment using specialized questionnaires. Some patients may later become eligible for surgery if their condition improves significantly with treatment.

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 assessment

    Your eligibility for the trial will be confirmed through medical tests and examinations

    The medical team will verify the presence of gastric cancer or cancer at the junction between stomach and esophagus

    A staging laparoscopy (small camera procedure) will be performed to assess cancer spread in the abdomen

  2. Step 2

    Treatment assignment

    You will be randomly assigned to one of two treatment groups:

    Group 1: Intraperitoneal paclitaxel plus standard therapy

    Group 2: Standard therapy alone

  3. Step 3

    Treatment administration

    You will receive medications through different methods:

    Intravenous medications (given through a vein): pembrolizumab, paclitaxel, oxaliplatin, nivolumab, docetaxel, fluorouracil, trastuzumab

    Intraperitoneal medication (given directly into the abdominal cavity): paclitaxel (Group 1 only)

    Oral medication: capecitabine (taken by mouth)

  4. Step 4

    Monitoring and follow-up

    Regular medical examinations to check your health status

    Blood tests to monitor bone marrow, liver, and kidney function

    Assessment of any side effects using standardized criteria

    Quality of life questionnaires during treatment and follow-up

    Imaging scans to evaluate treatment response

  5. Step 5

    Long-term observation

    Continued monitoring of your health status

    Regular assessments to track cancer progression

    Documentation of any additional treatments needed

    The study will continue until September 2030

Who can join the trial?

12 criteria

  • Must have confirmed gastric cancer or cancer of the junction between stomach and esophagus (food pipe), proven by tissue or cell examination
  • Must be at least 18 years old
  • Must have cancer that has spread to the peritoneum (the lining that covers abdominal organs), confirmed by tissue sample or fluid examination
  • Must have had a laparoscopy (camera examination of the abdomen) within 4 weeks before joining the study
  • Must have a life expectancy of at least 3 months
  • Must have good physical function, able to perform daily activities (ECOG score of 0-1)
  • Must have adequate blood test results showing: - Sufficient white blood cells (neutrophils >1500/mm3) - Adequate hemoglobin level (>8.0 g/dl) - Sufficient platelets (>100,000/mm3)
  • Must have adequate liver function based on blood tests
  • Must have adequate kidney function based on blood tests
  • For women who can become pregnant: Must use highly effective birth control during the study and for 9 months after the last treatment
  • For men: Must use appropriate birth control methods during the study and for 6 months after the last treatment, and agree not to donate sperm during this time
  • Must not be pregnant or breastfeeding if female

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 75 years
  • Previous treatment with chemotherapy (medication to kill cancer cells) for stomach cancer
  • History of other cancers in the past 5 years (except successfully treated non-melanoma skin cancer or cervical cancer)
  • Pregnancy or breastfeeding
  • Serious heart conditions including heart failure (when heart cannot pump blood effectively)
  • Severe liver problems
  • Severe kidney problems
  • Active serious infections
  • Peripheral neuropathy (nerve damage causing numbness or tingling in hands and feet) grade 2 or higher
  • Unable to take oral medications
  • Major surgery within 4 weeks before starting the study
  • Participation in other clinical trials within 30 days before this study
  • Mental conditions that prevent understanding of study requirements
  • Known allergic reactions to study medications
  • Serious medical conditions that could interfere with study participation
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Investigated drugs

Paclitaxel is a chemotherapy medication used to treat various types of 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. This medication works by stopping cancer cells from dividing and growing. Standard systemic therapy for gastric cancer typically includes a combination of chemotherapy medications given through the bloodstream to reach cancer cells throughout the body. The specific medications used in standard systemic therapy are not detailed in the provided data.

What is already known about the treatment

Paclitaxel - A chemotherapy medication administered both intravenously and intraperitoneally (directly into the abdominal cavity) for treating various types of cancer, particularly gastric cancer with peritoneal metastases. This drug belongs to the taxane family of chemotherapeutic agents and works by preventing cancer cell division by targeting and stabilizing the microtubules, which are essential cellular structures involved in cell division. Paclitaxel is widely established in medical practice and has been extensively studied in clinical trials, demonstrating significant efficacy in combination with systemic therapy for treating advanced gastric cancer, especially when administered directly into the peritoneal cavity to target cancer cells that have spread to the abdominal lining.

Investigated diseases

Gastric Cancer - A disease that begins in the cells of the stomach lining and can spread to other parts of the body. The condition typically develops slowly over many years, starting with changes in the inner layer of the stomach. It can grow through the stomach's wall layers and eventually form a mass or tumor. The cancer may spread to nearby lymph nodes and can also affect other organs. Gastric cancer often causes changes in how the stomach functions, affecting digestion and the body's ability to process nutrients.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514879-17-00Protocol codeIPa-Gastric 1.0Estimated enrolment146 patientsSponsorKarolinska University Hospital

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