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Study on Pressurized Intraperitoneal Aerosol Chemotherapy with Fluorouracil for Patients with Gastric Cancer with Peritoneal Metastases

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What is this trial about?

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

This clinical trial is focused on studying a type of stomach cancer known as gastric adenocarcinoma that has spread to the lining of the abdomen, referred to as peritoneal metastases. The study is investigating a treatment method called Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC), which is used in combination with other chemotherapy drugs. The chemotherapy drugs being studied include Fluorouracil, Docetaxel, Oxaliplatin, Calcium Levofolinate, Cisplatin, and Doxorubicin Hydrochloride. Additionally, a medication called Nivolumab, also known by its code name BMS936558, is part of the treatment regimen.

The purpose of this study is to determine if combining PIPAC with chemotherapy is more effective than using chemotherapy alone. The study will assess whether this combination increases the number of patients who can undergo surgery aimed at completely removing the cancer. It will also evaluate if the combination treatment helps patients live longer without the cancer getting worse. Participants in the study will receive treatment over a period of up to six months, with some receiving PIPAC in addition to chemotherapy, while others will receive chemotherapy alone. The study will monitor the effects of these treatments on the patients' health and quality of life.

Throughout the study, the safety and side effects of the treatments will be closely observed. The study aims to provide valuable information on the potential benefits of using PIPAC in combination with chemotherapy for treating gastric adenocarcinoma with peritoneal metastases. The findings could help improve treatment options for patients with this type of cancer in the future.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age, diagnosis, and health status.

    Informed consent is required to participate in the trial.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two treatment groups: Arm A or Arm B.

  3. Step 3

    Treatment in arm a

    Participants receive chemotherapy alone.

    Medications include fluorouracil, docetaxel, nivolumab, oxaliplatin, and calcium levofolinate, administered intravenously.

    Treatment consists of 6 to 12 cycles, with each cycle followed by evaluation.

  4. Step 4

    Treatment in arm b

    Participants receive a combination of chemotherapy and pressurized intraperitoneal aerosol chemotherapy (PIPAC).

    Chemotherapy medications include fluorouracil, docetaxel, nivolumab, oxaliplatin, and calcium levofolinate, administered intravenously.

    PIPAC involves the use of cisplatin and doxorubicin hydrochloride, administered intraperitoneally.

    Treatment consists of 6 cycles of chemotherapy and 3 PIPAC procedures.

  5. Step 5

    Evaluation and monitoring

    Progress is monitored through regular assessments, including imaging and biopsies.

    Quality of life is assessed using a questionnaire.

    Adverse events are recorded and evaluated.

  6. Step 6

    Surgery consideration

    The possibility of surgery with radical intent is evaluated based on treatment response.

    Surgery may involve cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC).

  7. Step 7

    Follow-up

    Participants are followed up to assess overall survival and progression-free survival.

    Long-term outcomes are compared between the two treatment groups.

Who can join the trial?

6 criteria

  • Age between 18-75 years
  • Have a first diagnosis of a type of stomach cancer called primary gastric adenocarcinoma that has not been treated before
  • Have a laparoscopic finding (a procedure using a small camera to look inside the abdomen) showing positive peritoneal cytology (cancer cells in the lining of the abdomen) and/or disease in the abdomen with a PCI (Peritoneal Cancer Index) of 6 or less, confirmed by a tissue test
  • Sign an informed consent form, which means you agree to participate in the study after understanding the details
  • Have an ECOG PS scale of 0-1, which is a measure of your ability to perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to do light work
  • If you are of childbearing potential, you will be included in the study and monitored with blood pregnancy tests before each chemotherapy cycle and each PIPAC (a type of treatment) and at the end of treatment. Oral contraceptives will not be used due to the high risk of blood clots related to the disease, but other contraceptives will be used according to guidelines.

Who cannot join the trial?

3 criteria

  • Patients who do not have gastric adenocarcinoma with peritoneal metastases. This means the study is only for those with a specific type of stomach cancer that has spread to the lining of the abdomen.
  • Patients who are not within the specified age range. The study is open to certain age groups, so those outside these groups cannot participate.
  • Patients who are part of a vulnerable population. This means people who might need special protection or care, like those with certain disabilities or conditions, are not included.
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Investigated drugs

  • PIPAC

    is a therapy used in this trial. It stands for Pressurized Intraperitoneal Aerosol Chemotherapy. This method involves delivering chemotherapy directly into the abdominal cavity in the form of a pressurized aerosol. The goal is to target cancer cells more effectively in patients with peritoneal gastric cancer, potentially improving outcomes when combined with other treatments.

  • CRS and HIPEC

    are surgical procedures that may be part of the treatment plan in this trial. CRS stands for Cytoreductive Surgery, which involves removing visible tumors from the abdominal cavity. HIPEC stands for Hyperthermic Intraperitoneal Chemotherapy, a procedure where heated chemotherapy is applied directly inside the abdomen after surgery to kill any remaining cancer cells. These procedures aim to achieve a more complete removal of cancer and improve patient survival.

What is already known about the treatment

PIPAC (Pressurized Intraperitoneal Aerosol Chemotherapy) – This treatment is administered directly into the abdominal cavity as an aerosol, allowing for targeted delivery of chemotherapy to cancerous tissues. It is currently being studied in clinical trials for its effectiveness in treating gastric adenocarcinoma with peritoneal metastases. The main therapeutic indication is to enhance the outcomes of patients with this type of cancer by potentially increasing the number of patients eligible for surgery and improving progression-free survival. At the molecular level, PIPAC works by delivering chemotherapy drugs directly to the tumor site, increasing drug concentration at the target while minimizing systemic exposure. It is classified under localized chemotherapy treatments.

Investigated diseases

Gastric adenocarcinoma with peritoneal metastases – This is a type of cancer that begins in the glandular cells of the stomach lining and spreads to the peritoneum, the tissue lining the abdominal wall and covering abdominal organs. The disease often progresses as cancer cells detach from the primary tumor in the stomach and implant themselves on the peritoneal surfaces. This spread can lead to the formation of new tumor nodules in the abdominal cavity, causing symptoms such as abdominal pain, bloating, and changes in bowel habits. As the disease advances, it can interfere with the function of abdominal organs and lead to fluid accumulation in the abdomen, known as ascites. The progression of this cancer is typically aggressive, with the potential for further spread to other organs.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515981-14-00Protocol codePIPAC_VEROneEstimated enrolment98 patientsSponsorAzienda Ospedaliera Universitaria Integrata Verona

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).