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Study of Avelumab with Chemotherapy for Patients with Resectable Stomach or Gastroesophageal Junction Cancer

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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 the treatment of two types of cancer: Gastric cancer and Gastroesophageal Junction cancer. The study will explore the effectiveness of a medication called Avelumab, which is a type of human antibody, when combined with a group of chemotherapy drugs. These chemotherapy drugs include Docetaxel, Oxaliplatin, Fluorouracil, and Calcium Folinate. The purpose of the study is to see if adding Avelumab to the chemotherapy treatment can improve the outcomes for patients with these cancers.

Participants in the study will receive the treatment intravenously, which means the medication will be given through a vein. The study will take place over a period of time, during which patients will receive the combination of Avelumab and chemotherapy drugs. The researchers aim to determine if this combination can lead to a complete response, meaning no remaining cancer cells, in the resected (surgically removed) cancer tissue. The study will also look at other outcomes, such as overall survival and disease-free survival, to understand the long-term effects of the treatment.

The trial is designed to provide valuable information on whether this new combination of treatments can offer better results compared to traditional chemotherapy alone. By participating in this study, researchers hope to gather data that could lead to improved treatment options for patients with Gastric cancer and Gastroesophageal Junction cancer. The study is conducted under strict guidelines to ensure the safety and well-being of all participants.

The research process

The trial runs in 6 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, the patient will undergo an initial assessment to confirm eligibility. This includes a review of medical history and a series of tests to ensure the patient meets the study criteria.
Step 2
Treatment initiation
The treatment phase begins with the administration of avelumab and chemotherapy drugs. The chemotherapy regimen includes docetaxel, oxaliplatin, and fluorouracil combined with calcium folinate. All medications are given intravenously.
The treatment is administered in cycles, with each cycle lasting a specific number of weeks. The exact duration and frequency of each cycle will be explained by the healthcare team.
Step 3
Monitoring and assessments
Throughout the treatment, regular monitoring and assessments are conducted to evaluate the patient's response to the therapy. This includes imaging tests and laboratory evaluations to track the progress of the treatment.
Step 4
Surgical intervention
If the treatment is effective, a surgical procedure may be scheduled to remove any remaining cancerous tissue. The timing and specifics of the surgery will depend on the patient's response to the treatment.
Step 5
Post-surgery follow-up
After surgery, follow-up visits are necessary to monitor recovery and ensure there are no signs of cancer recurrence. These visits may include physical examinations, imaging tests, and laboratory work.
Step 6
Long-term follow-up
Long-term follow-up is essential to assess overall survival and disease-free survival. This involves periodic check-ups over several years to monitor the patient's health status and detect any late effects of the treatment.

Who can join the trial?

14 criteria

The patient must have a type of cancer called **gastric cancer** or **gastroesophageal junction cancer** that can be surgically removed.
The cancer must be confirmed through a test called a **biopsy**, which involves taking a small sample of tissue to look at under a microscope.
Women who are not past menopause must use very effective birth control during the study and for 12 months after the last treatment.
Men must agree to use a condom and another form of birth control during the study and for 12 months after the last treatment.
Women who are not past menopause or who have not had surgery to remove their ovaries or uterus must have a negative pregnancy test before starting treatment and should not be breastfeeding.
The patient must agree to participate by signing a document called **informed consent**.
The patient must provide tissue samples from their cancer for research purposes.
The patient must have cancer that can be measured and does not have cancer spread to distant parts of the body, as confirmed by a **CT scan**.
The patient must be healthy enough to undergo surgery to remove the cancer, as determined by a team of doctors.
The cancer must be at a specific stage, called **UICC tumor stage Ib to IIIC**, based on a CT scan.
The patient must be at least 18 years old.
The patient must be in good general health, as indicated by a **WHO performance status** of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
The patient must have normal functioning of their organs, as shown by specific blood tests done within 7 days before starting treatment.
If the patient is taking blood thinners, they must switch to a different type of blood thinner given by injection before starting treatment.

Who cannot join the trial?

5 criteria

Patients who have a different type of cancer than **resectable gastric cancer** or **gastroesophageal junction cancer**. **Resectable** means the cancer can be removed by surgery.
Patients who are not within the specified age range for the study.
Patients who are not able to receive the specific **neoadjuvant chemotherapy** treatment. **Neoadjuvant chemotherapy** is treatment given before the main treatment, like surgery, to shrink the tumor.
Patients who have any medical condition that the study doctors think would make it unsafe for them to participate.
Patients who are part of a vulnerable population that the study is not designed to include. **Vulnerable populations** can include groups like children, pregnant women, or people with certain disabilities.

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Verified sites

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

Verified
Hospital Universitario De Navarra
Pamplona, Spain
Responsive
Hospital Universitario Hm Sanchinarro
Madrid, Spain
Verified
Hospital Universitario Marques De Valdecilla
Santander, Spain

Trial locations

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Investigated drugs

Avelumab
is a type of immunotherapy used in this trial. It works by helping the body's immune system recognize and attack cancer cells more effectively. In this study, it is being tested to see if it can improve the treatment outcomes for patients with gastric cancer or gastroesophageal junction cancer when used alongside chemotherapy.
Docetaxel
is a chemotherapy medication that helps stop the growth of cancer cells by interfering with their ability to divide. It is part of the chemotherapy regimen used in this trial to treat patients with gastric cancer or gastroesophageal junction cancer.
Oxaliplatin
is another chemotherapy drug used in this study. It works by damaging the DNA of cancer cells, which prevents them from growing and dividing. It is combined with other chemotherapy drugs to enhance the treatment's effectiveness.
Fluorouracil
is a chemotherapy medication that targets cancer cells by interfering with their DNA and RNA production, which are essential for cell growth and division. It is used in combination with other drugs in this trial to treat gastric cancer or gastroesophageal junction cancer.
Leucovorin
is used in this trial to enhance the effectiveness of fluorouracil. It helps fluorouracil work better by stabilizing the bond between the drug and the cancer cell's DNA, making the treatment more effective.

What is already known about the treatment

Avelumab
Avelumab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating resectable gastric cancer and gastroesophageal junction cancer. It is an immunotherapy drug that works by blocking a protein called PD-L1, which helps cancer cells evade the immune system. By inhibiting this protein, avelumab allows the immune system to better recognize and attack cancer cells. It is classified as a monoclonal antibody and is being evaluated for its potential to improve treatment outcomes when combined with chemotherapy.
Docetaxel
Docetaxel is given through an intravenous infusion and is a well-established chemotherapy medication used in various cancer treatments, including gastric and gastroesophageal junction cancers. It works by disrupting the microtubule network in cells, which is essential for cell division, thereby inhibiting cancer cell growth. Docetaxel is classified as a taxane and is often used in combination with other chemotherapy agents to enhance its effectiveness.
Oxaliplatin
Oxaliplatin is administered intravenously and is a chemotherapy drug commonly used in combination with other medications to treat gastric and gastroesophageal junction cancers. It functions by forming cross-links in DNA, which prevents cancer cells from replicating and leads to cell death. Oxaliplatin is classified as a platinum-based drug and is part of the standard treatment regimen for these types of cancers.
Fluorouracil
Fluorouracil is given intravenously and is a chemotherapy medication used to treat various cancers, including gastric and gastroesophageal junction cancers. It works by interfering with the synthesis of DNA and RNA, which are necessary for cancer cell growth and division. Fluorouracil is classified as an antimetabolite and is often used in combination with other drugs to improve treatment efficacy.
Leucovorin
Leucovorin is administered intravenously and is used in combination with fluorouracil to enhance its effectiveness in treating gastric and gastroesophageal junction cancers. It acts as a biochemical modulator that stabilizes the binding of fluorouracil to its target enzyme, thereby increasing the drug's anticancer activity. Leucovorin is classified as a folinic acid and is an important component of combination chemotherapy regimens.

Investigated diseases

Gastric 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. Symptoms may include indigestion, stomach pain, nausea, and weight loss. The disease can spread to lymph nodes and other parts of the body. Early detection is challenging as symptoms often appear in advanced stages.
Gastroesophageal Junction Cancer
Gastroesophageal junction cancer occurs where the esophagus meets the stomach. This type of cancer typically arises from the cells lining this area. It can cause difficulty swallowing, chest pain, and unintentional weight loss. As the cancer progresses, it may invade surrounding tissues and spread to distant organs. The disease can affect the esophagus's ability to move food to the stomach. Early symptoms are often subtle, making early diagnosis difficult.