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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 study about?

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.

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Hm Sanchinarro Madrid Spain
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Hnnoaasi Ukyzapomrwlhb Mkwojqk Dy Vhaukrxavz Santander Spain
Iukrsatf Cwpumw Dgxgcjikfgjheaijl L'hospitalet De Llobregat Spain
Hpjdzago Vfsb dwdxcumr Barcelona Spain

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

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
17.01.2020

Trial locations

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.

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.

Trial ID:
2024-516777-77-00
Protocol code:
VHIO19001
Trial Phase:
Therapeutic exploratory (Phase II)

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