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Study of Preoperative FLOT4 and Intraperitoneal Chemotherapy with Hyperthermia (HIPEC) for Advanced Gastric Cancer Patients at High Risk of 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 patients with advanced gastric cancer, specifically studying a treatment combination that includes FLOT4 chemotherapy and a procedure called HIPEC (heated intraperitoneal chemotherapy). The treatment involves delivering chemotherapy directly into the abdominal cavity with heat before surgery. The study aims to determine if this combined approach can reduce cancer spread to the lining of the abdomen after stomach removal surgery.

The treatment plan combines standard chemotherapy given through a vein with a special procedure where irinotecan, an anti-cancer medication, is heated and delivered directly into the abdominal cavity. This heated chemotherapy treatment is given before the surgery to remove the stomach. Patients will receive at least three rounds of regular chemotherapy before the heated chemotherapy procedure.

During the study, doctors will monitor how well the treatment prevents the cancer from returning to the abdomen's lining. They will also track overall patient recovery and well-being using quality of life surveys. The treatment approach being studied may offer a new way to treat stomach cancer patients who have a high risk of the cancer spreading to the abdominal cavity.

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 phase

    You will receive at least 3 cycles of preoperative FLOT chemotherapy before proceeding with the next phase of treatment

    This treatment is administered before the main surgical procedure

  2. Step 2

    Treatment assignment

    You will be randomly assigned to one of two treatment groups

    One group receives standard treatment, while the other receives additional intraperitoneal chemotherapy with hyperthermia (HIPEC)

  3. Step 3

    Surgical procedure

    A gastrectomy (surgical removal of the stomach) will be performed

    If you are in the HIPEC group, you will receive heated chemotherapy treatment directly in the abdominal cavity during surgery

  4. Step 4

    Follow-up assessments

    Regular check-ups will occur to monitor your recovery

    You will complete quality of life questionnaires (QLQ-C30 and STO22)

    Medical examinations will be conducted to check for any signs of cancer recurrence

    A specific evaluation will be performed 6 months after surgery to check for signs of cancer in the peritoneal cavity

  5. Step 5

    Long-term monitoring

    Your health status will be monitored until the study ends in June 2026

    Regular assessments will track your overall survival and disease-free status

    Continued quality of life evaluations will be performed using standardized questionnaires

Who can join the trial?

7 criteria

  • Patient must be between 18 and 75 years old
  • Patient must have gastric cancer confirmed by gastroscopy (examination of the stomach using a special camera) and tissue sample analysis
  • Patient must have advanced stomach cancer that has grown into deeper layers of the stomach wall but has not spread to other parts of the body
  • Patient must have no evidence of cancer spread to distant organs, as shown on CT scans of the chest, abdomen, and pelvis
  • Patient must have completed at least 3 cycles of FLOT chemotherapy (a specific combination of cancer medicines) before surgery
  • Patient must be able to understand and sign an informed consent form agreeing to participate in the study
  • Both men and women can participate in this study

Who cannot join the trial?

14 criteria

  • Age below 18 years or above 75 years
  • Presence of distant metastases (cancer spread to other parts of the body)
  • Previous chemotherapy or radiation therapy for gastric cancer
  • Severe heart conditions including heart failure or recent heart attack
  • Significant liver problems or liver dysfunction
  • Severe kidney problems or renal insufficiency
  • Active infections requiring treatment
  • Pregnancy or breastfeeding
  • Known allergies to the study medications
  • Participation in other clinical trials within the last 30 days
  • Immunodeficiency disorders (weakened immune system)
  • Psychological conditions that could affect participation
  • Inability to follow study procedures or attend follow-up visits
  • History of other cancers in the past 5 years (except for successfully treated non-melanoma skin cancer)
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Investigated drugs

FLOT4 is a combination chemotherapy treatment that includes several medications working together to fight gastric cancer. It is given through an intravenous infusion before and after surgery. HIPEC (Hyperthermic Intraperitoneal Chemotherapy) is a specialized treatment where heated chemotherapy drugs are circulated directly in the abdominal cavity during surgery. This technique allows the medication to directly target cancer cells in the peritoneum (the lining of the abdominal cavity) while being heated to enhance its effectiveness. Both treatments are used together to help prevent cancer from spreading to the peritoneal cavity in patients with advanced gastric cancer who are undergoing surgery.

What is already known about the treatment

  • FLOT4

    A chemotherapy regimen consisting of four drugs (5-fluorouracil, leucovorin, oxaliplatin, and docetaxel) administered intravenously in perioperative treatment of advanced gastric cancer. This combination therapy works by targeting rapidly dividing cancer cells through multiple mechanisms, including DNA damage and cell division disruption. FLOT4 is currently considered a standard treatment protocol for patients with operable gastric cancer, showing significant improvement in survival rates compared to older regimens. The treatment is typically given both before and after surgery (perioperative approach) to reduce tumor size and prevent cancer recurrence.

  • HIPEC

    Hyperthermic Intraperitoneal Chemotherapy is a specialized treatment procedure where heated chemotherapy drugs are circulated directly in the abdominal cavity during surgery. This targeted approach combines the effects of high temperature and chemotherapy to eliminate cancer cells that may be present in the peritoneal cavity. HIPEC is administered during surgery after tumor removal, with the solution heated to approximately 42°C (107.6°F), which enhances the penetration and effectiveness of the chemotherapy drugs while reducing systemic side effects compared to traditional intravenous chemotherapy.

Investigated diseases

Gastric Carcinoma - A cancer that develops in the stomach's inner lining, typically beginning in the cells that line the stomach wall. The disease usually develops slowly over many years, starting with pre-cancerous changes in the stomach's mucosa. As it progresses, the cancer can grow through the stomach's wall layers and may spread to nearby lymph nodes and other organs. The condition often begins with changes in the way stomach cells grow and divide, forming a tumor that can expand locally. Early stages may not cause noticeable symptoms, but as the disease advances, it can affect the stomach's normal functions.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-516042-18-00Protocol codeGastricCHIMERAtrialEstimated enrolment182 patientsSponsorUniwersytet Jagiellonski Collegium Medicum

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