Not recruiting

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

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 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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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
Step 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
Step 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
Step 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 trial?

18 criteria

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 trial?

16 criteria

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)

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Assistance Publique Hopitaux De Marseille
Verified
Marseille, France
Assistance Publique Hopitaux De Paris
Verified
Paris, France
Centr Georges Francois Leclerc
Verified
Dijon, France

Trial locations

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Investigated drugs

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.

What is already known about the treatment

Spartalizumab (PDR001)
A novel immunotherapy drug administered through intravenous infusion that belongs to the class of PD-1 inhibitors. This medication works by blocking the PD-1 protein on immune cells, helping the body's immune system to better recognize and attack cancer cells. Currently being investigated in clinical trials for treating resectable gastric cancer in combination with chemotherapy, showing promising results in enhancing the immune response against tumor cells.
Fluorouracil (5-FU)
An intravenously administered chemotherapy medication that belongs to the antimetabolite class of drugs. It works by interfering with DNA synthesis in rapidly dividing cells, particularly targeting cancer cells and preventing their growth and multiplication. This well-established medication has been a cornerstone in treating various types of cancer, including gastric cancer, and is commonly used as part of combination chemotherapy regimens.
Leucovorin
A form of folic acid administered intravenously that is commonly used in combination with fluorouracil chemotherapy. It helps enhance the effectiveness of fluorouracil while reducing its side effects by protecting healthy cells. This medication acts as a "rescue" agent by providing essential nutrients to normal cells while allowing the chemotherapy to continue targeting cancer cells.
Oxaliplatin
An intravenous platinum-based chemotherapy drug that works by forming cross-links in DNA, preventing cancer cells from dividing and growing. It is commonly used in combination with other chemotherapy drugs for treating various gastrointestinal cancers, including gastric cancer, and has become a standard component in many treatment protocols.
Docetaxel
An intravenous chemotherapy medication belonging to the taxane family of drugs. It works by disrupting the normal function of microtubules in cancer cells, preventing cell division and leading to cell death. This medication is widely used in various cancer treatments and has shown effectiveness in combination therapy for gastric cancer.

Investigated diseases

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.