Study of Spartalizumab combined with FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, docetaxel) for patients with resectable gastric cancer before and after surgery

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What is this study about?

This study focuses on treating patients with resectable gastric cancer. The treatment combines several medications: spartalizumab (also known as PDR001) with a combination of drugs called FLOT, which includes fluorouracil, folinic acid (leucovorin), oxaliplatin, and docetaxel. These medications are given through intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of this research is to evaluate how well the tumor responds to treatment before surgery. The treatment is given both before and after surgery, which is known as perioperative treatment. During surgery, doctors will examine the tumor tissue to determine if any cancer cells remain after the initial treatment phase.

Patients will receive the combination of medications over multiple treatment cycles. The medications are given as solutions that are diluted and then infused into a vein. The treatment period may last up to 16 weeks, during which patients will be monitored for how well the treatment works and any side effects that may occur.

1 Initial treatment phase – before surgery

You will receive a combination of medications through intravenous infusion. The treatment includes five drugs:

Docetaxel (Docetaxel Hospira)

Oxaliplatin (Oxaliplatine Sun)

Folinic acid (Folinate de Calcium)

Spartalizumab (PDR001)

Fluorouracil (Fluorouracile Accord)

All medications will be administered through an intravenous line directly into your bloodstream

2 Surgery phase

After completing the initial treatment, you will undergo surgery to remove the gastric cancer

The surgical team will collect tissue samples during the operation

The removed tissue will be examined by a pathologist to evaluate how well the treatment worked

3 Post-surgery monitoring

Your recovery will be monitored for 30 days after surgery

Regular health assessments will be conducted during your hospital stay

Blood samples will be collected for analysis

4 Long-term follow-up

Your health status will be monitored until September 2027

Regular check-ups will assess if the cancer has returned

Your overall health and survival will be tracked throughout this period

Who Can Join the Study?

  • Must be at least 18 years old
  • Must have social security coverage
  • Must sign informed consent forms before starting any study procedures
  • Must have untreated localized stomach or gastroesophageal junction cancer that can be surgically removed
  • Must have confirmed diagnosis of adenocarcinoma (a type of cancer that starts in gland cells)
  • Must have good physical function status (ECOG score of 0 or 1, meaning able to perform daily activities)
  • Must provide tumor tissue samples for testing
  • Must agree to provide blood samples for research
  • Must meet specific blood test requirements including:
    • Adequate white blood cell count
    • Adequate neutrophil count (type of white blood cells)
    • Adequate platelet count
    • Adequate hemoglobin level
    • Normal liver and kidney function tests
    • Normal levels of potassium, magnesium, and calcium
  • Women who can become pregnant must have a negative pregnancy test within 72 hours before starting the study
  • Participants of reproductive age must use effective birth control during the study and for:
    • 9 months after last dose for men
    • 12 months after last dose for women
  • Male participants will be offered the option to preserve sperm samples

Who Cannot Join the Study?

  • History of other cancers within the past 5 years (except treated non-melanoma skin cancer or cervical cancer in situ)
  • Presence of metastatic disease (cancer that has spread to other parts of the body)
  • Previous chemotherapy or radiotherapy for gastric cancer
  • Serious heart conditions, including:
    • Heart attack in the last 6 months
    • Unstable heart disease
    • Heart failure requiring treatment
  • Active, uncontrolled infections
  • Severe liver problems (liver function tests more than 3 times normal limits)
  • Severe kidney problems (creatinine clearance less than 30 mL/min)
  • Pregnancy or breastfeeding
  • Known allergies to study medications
  • Participation in another clinical trial within the last 30 days
  • Mental conditions that could interfere with study compliance
  • Unable to swallow oral medications
  • Active bleeding from the digestive tract
  • Uncontrolled diabetes mellitus (high blood sugar)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centr Georges Francois Leclerc Dijon France
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Poitiers Poitiers France
Centre Hospitalier Regional Universitaire Besançon France
Institut de Cancérologie de l’Ouest Saint-Herblain France
Centre Francois Baclesse Caen France
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Groupe Hospitalier Rance Emeraude Saint-Malo France
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Ihxbahvd Mljsjrijmt Muglrnjssm Paris France
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Akpmenamss Pqxvblsy Hhjtrtcu Ds Mdsufepka Marseille France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
28.06.2021

Trial locations

Spartalizumab (PDR001) is an immunotherapy medication that helps the body’s immune system fight cancer cells. It works by blocking certain proteins that cancer cells use to hide from the immune system, allowing the body’s natural defenses to better recognize and attack the cancer.

Fluorouracil is a chemotherapy medication that works by stopping cancer cells from growing and dividing. It is commonly used to treat various types of cancer, including gastric (stomach) cancer.

Leucovorin is a medication used alongside fluorouracil to enhance its effectiveness while helping to reduce some side effects of chemotherapy. It is not a cancer-fighting drug itself but helps other chemotherapy work better.

Oxaliplatin is a chemotherapy medication that works by preventing cancer cells from dividing and growing. It is often used in combination with other medications to treat various types of cancer, particularly those affecting the digestive system.

Docetaxel is a chemotherapy medication that works by stopping cancer cells from dividing and spreading. It belongs to a class of drugs called taxanes and is used to treat various types of cancer.

Gastric Cancer – A disease that begins in the cells of the stomach lining and can spread to other parts of the stomach. It develops gradually over many years, starting when stomach cells begin to grow abnormally and form masses called tumors. The term “resectable” means the cancer can be surgically removed. Early changes often occur in the inner lining (mucosa) of the stomach and can progress to deeper layers over time. The cancer may grow through the stomach’s outer wall and spread to nearby organs or lymph nodes.

Note: I provided only one disease description since the source data mentions only “Resectable Gastric Cancer” as the medical condition being studied.

Trial ID:
2024-516299-13-00
Protocol code:
GASPAR
NCT ID:
NCT04736485
Trial Phase:
Therapeutic exploratory (Phase II)

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