Study of Preoperative FLOT4 and Intraperitoneal Chemotherapy with Hyperthermia (HIPEC) for Advanced Gastric Cancer Patients at High Risk of Peritoneal Metastases

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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)

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy	Bydgoszcz	Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie	Lublin	Poland
Dtutjghsigho Cbhamgd Obqnzhjnl Pnpgqrqvnted I Howggztdzxt	Wroclaw	Poland
Sattosu Uqcggopwrayfd Iycmkhl Kfawgb Mdiovvumqxiedmy W Zfcpkqgp Gpaka Sxh z ol of	Zielona Gora	Poland
Ncppgmkn Iwgtsdse Oyjimlrjp Irv Muiev Sgyytwmewnupyubkdoslkstkohai Ifsvvbwm Bfylxdvi	Cracow	Poland

Trial status

Country	Status	Recruitment Start
Poland	Not recruiting	01.02.2021

Trial locations

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.

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 ID:

2024-516042-18-00

Protocol code:

GastricCHIMERAtrial

Trial Phase:

Therapeutic use (Phase IV)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?