Recruiting

Study on Pre-operative Capecitabine, Oxaliplatin, Docetaxel, and Atezolizumab for Patients with Resectable Gastric or Gastro-esophageal Junction Cancer

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 clinical trial is focused on studying treatments for a type of cancer called gastric cancer, which affects the stomach, and gastro-esophageal junction cancer, which occurs where the stomach meets the esophagus. The study involves using a combination of medications to see how safe and feasible they are for patients with these cancers. The medications being tested include capecitabine, oxaliplatin, docetaxel, and atezolizumab. Atezolizumab is also known by its code name RO5541267. These medications are used to treat cancer by either killing cancer cells or helping the immune system fight the cancer.

The purpose of the study is to explore the safety and feasibility of these medications when given before surgery to remove the cancer. Patients will receive these treatments over a period of time before their surgery. The study will monitor how the body responds to the medications and any side effects that may occur. Some patients will receive a placebo, which is a substance with no active medication, to compare the effects of the actual medications.

Throughout the study, patients will undergo various tests and procedures to assess the impact of the treatment on their cancer. This includes checking how the cancer responds to the treatment and any changes in the immune system. The study aims to gather information on how well these treatments work together and their safety for patients with gastric and gastro-esophageal junction cancer.

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
Initial treatment phase
The treatment begins with the administration of oxaliplatin and docetaxel. These medications are given through an intravenous infusion. The specific dosage and frequency will be determined by the healthcare provider based on individual patient needs.
In addition to the intravenous medications, capecitabine is taken orally in the form of film-coated tablets. The dosage and schedule for taking these tablets will be provided by the healthcare team.
Step 2
Immunotherapy phase
Following the initial treatment phase, atezolizumab is administered. This medication is also given intravenously. The healthcare provider will specify the dosage and frequency of administration.
The purpose of this phase is to enhance the body's immune response against cancer cells.
Step 3
Combination treatment phase
During this phase, the treatment involves a combination of capecitabine, oxaliplatin, docetaxel, and atezolizumab. The medications are administered as previously described, with specific schedules and dosages provided by the healthcare team.
This phase aims to maximize the effectiveness of the treatment by using multiple medications together.
Step 4
Surgical evaluation
After completing the combination treatment phase, an evaluation is conducted to assess the response to the treatment. This may involve imaging studies and other diagnostic tests.
The results of this evaluation will determine the next steps, which may include surgery to remove any remaining cancerous tissue.
Step 5
Follow-up and monitoring
Following the surgical evaluation, regular follow-up appointments are scheduled to monitor the patient's recovery and check for any signs of cancer recurrence.
These appointments may include physical examinations, imaging tests, and laboratory tests to ensure the patient's health and well-being.

Who can join the trial?

13 criteria

You must sign a form agreeing to participate in the study.
You need to be willing to have a procedure called esophagogastroscopy, which is a test to look inside your esophagus and stomach, and provide tissue samples before and during the treatment.
If you are a woman who can have children, you must have a negative pregnancy test within 14 days before starting the treatment.
If you are a man who is sexually active with a woman who can have children, you must use a reliable birth control method during the study and for 31 weeks after the last dose of the study drug.
If you are a woman who can have children, you must agree to either not have heterosexual intercourse or use a reliable birth control method during the study and for 5 months after the last dose of the study drug.
You must have a type of cancer called **gastric or gastro-esophageal junction adenocarcinoma** that can be surgically removed and has been confirmed by a tissue test.
You must have an **ECOG performance status** of 0 or 1, which means you are fully active or have some symptoms but can still do light work.
You must be 18 years old or older.
You must not have any signs of cancer spread to distant parts of the body.
You must have adequate blood and organ function, as shown by specific blood test results taken within 14 days before starting the study treatment.
If you are taking blood thinners, your treatment must be stable.
You must have a CT scan of your chest and abdomen within 4 weeks before joining the study. A PET scan and EUS (a type of ultrasound) are required for tumors at the gastro-esophageal junction and optional for stomach cancers.
If you have a type of stomach cancer called diffuse type, a procedure called diagnostic laparoscopy must be done to ensure there are no signs of cancer spread to the lining of the abdomen.

Who cannot join the trial?

5 criteria

Patients who do not have a type of stomach cancer called **gastric adenocarcinoma** or a similar cancer at the place where the stomach meets the esophagus, known as the **gastro-esophageal junction**.
Patients who have not had their cancer confirmed by a test called a **histological examination**, which involves looking at tissue under a microscope.
Patients who have cancer that cannot be surgically removed, which means it is not **resectable**.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Catharina Ziekenhuis Stichting
Eindhoven, The Netherlands

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Investigated drugs

Capecitabine
is a medication used in cancer treatment. It works by interfering with the growth of cancer cells, slowing down or stopping their spread. In this trial, it is used before surgery to help shrink the tumor in the stomach or the area where the stomach meets the esophagus.
Oxaliplatin
is a chemotherapy drug that helps to kill cancer cells. It is often used in combination with other medications to enhance its effectiveness. In this trial, it is part of the treatment given before surgery to reduce the size of the tumor.
Docetaxel
is another chemotherapy medication that targets cancer cells, preventing them from dividing and growing. It is used in this trial to help reduce the tumor size before surgical removal.
Atezolizumab
is an immunotherapy drug that helps the immune system recognize and attack cancer cells. It is used in this trial to boost the body's natural defenses against the tumor, making it easier to remove surgically.

What is already known about the treatment

Capecitabine
Capecitabine is administered orally in the form of tablets. It is currently used in clinical trials for treating gastric and gastro-esophageal junction adenocarcinoma. The main therapeutic indication is for cancers that are resectable and non-metastatic. Capecitabine works by interfering with DNA synthesis, inhibiting cancer cell growth. It is classified as an antimetabolite.
Oxaliplatin
Oxaliplatin is given intravenously. It is being studied in clinical trials for its effectiveness in treating gastric and gastro-esophageal junction adenocarcinoma. The drug is used for non-metastatic, resectable cancers. Oxaliplatin works by forming cross-links in DNA, which prevents cancer cells from dividing. It belongs to the class of platinum-based chemotherapy drugs.
Docetaxel
Docetaxel is administered through intravenous infusion. It is part of clinical trials for treating gastric and gastro-esophageal junction adenocarcinoma. The drug is indicated for non-metastatic, resectable cancers. Docetaxel works by stabilizing microtubules, which inhibits cell division. It is classified as a taxane chemotherapy agent.
Atezolizumab
Atezolizumab is given as an intravenous infusion. It is being tested in clinical trials for its role in treating gastric and gastro-esophageal junction adenocarcinoma. The medication is used for non-metastatic, resectable cancers. Atezolizumab works by blocking the PD-L1 protein, enhancing the immune system's ability to attack cancer cells. It is classified as an immune checkpoint inhibitor.

Investigated diseases

Gastric Adenocarcinoma
This is a type of cancer that begins in the glandular cells of the stomach lining. It typically progresses slowly, starting in the innermost layer of the stomach and potentially spreading to deeper layers and nearby organs. Symptoms may include indigestion, stomach pain, nausea, and weight loss. As the disease advances, it can lead to more severe symptoms and complications. The progression can vary significantly among individuals, influenced by factors such as the cancer's location and the patient's overall health. Early detection is crucial for managing the disease effectively.
Gastroesophageal Junction Adenocarcinoma
This cancer occurs where the esophagus meets the stomach, known as the gastroesophageal junction. It often begins in the cells lining this area and can spread to nearby tissues and organs. Symptoms might include difficulty swallowing, chest pain, and unintentional weight loss. The disease can progress at different rates, depending on various factors, including the tumor's size and location. As it advances, it may cause more severe symptoms and complications. Understanding its progression is essential for determining appropriate management strategies.