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Study on Trastuzumab Deruxtecan and Fluorouracil for Patients with HER2-Positive Gastric or Gastroesophageal Cancer with Minimal Residual Disease

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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 treatments for HER2-positive gastric or gastroesophageal cancer. The study will compare a new treatment combination of trastuzumab deruxtecan (also known as DS-8201a) and fluoropyrimidine with standard chemotherapy options. The standard chemotherapy options include medications like fluorouracil, capecitabine, docetaxel, calcium folinate, and oxaliplatin. These treatments are administered through intravenous infusion, which means they are given directly into the bloodstream through a vein.

The purpose of the study is to see if the new treatment combination can help clear a specific type of cancer-related DNA, known as ctDNA, from the blood. This DNA is a marker that can indicate the presence of cancer cells. The study will involve patients who have already undergone surgery and chemotherapy but still have minimal residual disease, which means small amounts of cancer cells remain in the body. The trial will last for about a year, during which patients will receive either the new treatment combination or continue with the standard chemotherapy regimen.

Throughout the study, researchers will monitor the patients' health and track the presence of ctDNA in their blood. They will also assess other outcomes, such as how long patients remain free from cancer recurrence and overall survival rates. The goal is to determine if the new treatment is more effective than the standard options in reducing the risk of cancer returning and improving patient outcomes.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be required to provide written informed consent. This means you agree to participate in the study and understand what it involves.
You will undergo a series of initial tests to confirm eligibility, including a liquid biopsy to check for minimal residual disease after your surgery.
Step 2
Randomization
Once eligibility is confirmed, you will be randomly assigned to one of two treatment groups. This process is called randomization and ensures that each participant has an equal chance of receiving either the new treatment or the standard treatment.
Step 3
Treatment phase
If you are in the new treatment group, you will receive trastuzumab deruxtecan and capecitabine. Trastuzumab deruxtecan is given as an intravenous infusion, which means it is administered directly into your vein. Capecitabine is taken orally in the form of tablets.
If you are in the standard treatment group, you will continue with the FLOT regimen, which includes fluorouracil, anhydrous docetaxel, calcium folinate, and oxaliplatin. These medications are also given as intravenous infusions.
The treatment phase will last for a specified period, and you will receive these medications at regular intervals as determined by the study protocol.
Step 4
Follow-up assessments
Throughout the study, you will have regular follow-up assessments to monitor your health and the effectiveness of the treatment. These assessments may include blood tests, imaging scans, and other evaluations as needed.
The primary goal is to determine the clearance of circulating tumor DNA (ctDNA) and to assess your overall health status.
Step 5
End of study
At the end of the study, you will have a final assessment to evaluate the outcomes of the treatment. This will include a review of your health and any changes observed during the study period.
You will be informed about the results and any further steps or recommendations for your care.

Who can join the trial?

16 criteria

Must provide written informed consent before any study-related procedures.
Must have a specific type of cancer: gastric or gastroesophageal cancer.
Must have a test showing HER2 overexpression/amplification on tissue samples. HER2 is a protein that can affect the growth of cancer cells.
Must have a positive result from a liquid biopsy test done 2-6 weeks after surgery. A liquid biopsy is a blood test that looks for cancer cells or DNA.
Must have a Left Ventricular Ejection Fraction (LVEF) of 50% or higher. LVEF is a measure of how well the heart is pumping blood.
Must have adequate bone marrow and organ function as determined by specific tests.
Females of childbearing potential must have a negative pregnancy test and use effective birth control methods if sexually active.
Females must not be breastfeeding during the study and for 7 months after the last dose of the study drug.
Males must use a condom with spermicide if sexually active with a female partner of childbearing potential, and should not father a child during the study and for 4 months after the last dose of the study drug.
Must be willing to comply with all study procedures and treatments.
Must be at least 18 years old.
Must have an ECOG Performance Status of 0-1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
Must have a life expectancy of at least 12 weeks.
Must have a diagnosis of localized or locally advanced gastric or gastroesophageal junction cancer eligible for standard pre-operative chemotherapy followed by surgery.
Must have had surgery to remove the cancer after completing pre-operative chemotherapy.
Must not have distant metastases, meaning the cancer has not spread to distant parts of the body.

Who cannot join the trial?

10 criteria

Patients with any other type of cancer besides **gastric or gastroesophageal cancer** cannot participate.
Patients who have not fully recovered from previous cancer treatments are excluded.
Patients with serious heart problems are not eligible.
Patients with uncontrolled high blood pressure cannot join the study.
Patients with active infections that require treatment are excluded.
Patients who are pregnant or breastfeeding cannot participate.
Patients with known allergies to the study drugs are not eligible.
Patients who have participated in another clinical trial within the last 30 days are excluded.
Patients with a history of drug or alcohol abuse in the past year cannot join the study.
Patients with any other medical condition that the study doctors think would make it unsafe for them to participate are excluded.

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Verified sites

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

Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Responsive
Azienda Ospedaliero Universitaria Parma
Parma, Italy
Responsive
Istituto Europeo Di Oncologia S.r.l.
Milan, Italy

Trial locations

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Investigated drugs

Trastuzumab deruxtecan
is a medication used in this trial to target cancer cells that have a protein called HER2. It works by attaching to the HER2 protein on the cancer cells and delivering a powerful drug directly into the cells to help kill them. This medication is being tested to see if it can help clear cancer-related DNA from the blood after surgery and chemotherapy.
Capecitabine
is a type of chemotherapy that is taken as a pill. It works by interfering with the DNA of cancer cells, which stops them from growing and dividing. In this trial, it is used in combination with other treatments to see if it can help eliminate any remaining cancer cells after surgery.
5-Fluorouracil
is another chemotherapy drug used in this trial. It is usually given through an injection and works by blocking the growth of cancer cells. This medication is part of the treatment plan to help reduce the risk of cancer coming back after surgery.
FLOT
is a combination of four different chemotherapy drugs used as a standard treatment for certain types of stomach cancer. It includes 5-Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel. This combination is used to attack cancer cells in different ways, making it harder for the cancer to survive and grow. In this trial, FLOT is used as a comparison to see if the new treatment approach is more effective.

What is already known about the treatment

Trastuzumab deruxtecan – This medication is administered intravenously, meaning it is given through a vein, usually in a hospital or clinic setting. It is currently being studied in clinical trials for its effectiveness in treating HER2-positive gastric or gastroesophageal cancer, particularly in patients who still have minimal residual disease after surgery and chemotherapy. The drug works by targeting and binding to the HER2 protein on cancer cells, delivering a toxic substance directly to these cells to kill them. It is classified as an antibody-drug conjugate, which combines an antibody with a chemotherapy drug to specifically target cancer cells.

Investigated diseases

Gastric or gastroesophageal cancer – Gastric cancer, also known as stomach cancer, begins in the cells lining the stomach. It often starts in the mucus-producing cells on the stomach's inner surface. As the disease progresses, it can invade deeper layers of the stomach wall and spread to nearby organs. Gastroesophageal cancer involves the area where the stomach meets the esophagus. This type of cancer can cause difficulty swallowing and may spread to lymph nodes and other parts of the body. Both types of cancer can grow slowly over time, often without symptoms in the early stages.