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Study of trastuzumab with chemotherapy and immunotherapy combination for first-line treatment in patients with HER2-positive esophageal squamous cell cancer

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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 Esophageal Squamous Cell Carcinoma (ESCC), a type of cancer that develops in the lining of the food pipe (esophagus). The study specifically targets patients whose cancer cells have high levels of a protein called HER2. The purpose is to evaluate how well adding a medication called trastuzumab works when combined with standard treatment.

The treatment plan combines several medications. Patients will receive pembrolizumab, which helps the immune system fight cancer cells, along with chemotherapy drugs including fluorouracil, oxaliplatin, and capecitabine. These medications will be given together with Trazimera (trastuzumab), which specifically targets HER2-positive cancer cells.

Most medications in this study will be given through an intravenous infusion directly into the bloodstream, while some will be taken as tablets by mouth. The treatment will continue as long as it remains beneficial for the patient and side effects are manageable. Doctors will regularly monitor the patient's heart function and overall health throughout the treatment period.

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
You will receive a combination of medications to treat esophageal squamous cell carcinoma
The treatment includes several medications administered in different ways:
- Pembrolizumab given through an intravenous (IV) line
- Fluorouracil given through an IV line
- Capecitabine taken as oral tablets
- Oxaliplatin given through an IV line
- Trastuzumab given through an IV line
Step 2
Monitoring period
Regular checks of your heart function will be performed to ensure it remains above 50%
Your blood will be tested regularly to monitor:
- White blood cell count
- Liver function
- Kidney function
Step 3
Progress evaluation
Your response to treatment will be evaluated after 6 months
Doctors will check if the cancer has progressed using medical imaging
The study will continue until February 2027
Step 4
Safety monitoring
Throughout the treatment, you will be monitored for:
- Changes in blood test results
- Heart function
- Any side effects from the medications

Who can join the trial?

12 criteria

You must sign an informed consent form to participate in the study
You must be at least 18 years old
You must have inoperable advanced or metastatic esophageal cancer that cannot be treated with curative therapy
Your cancer must be HER2-positive, which will be determined through specific laboratory tests of your tumor tissue
Your physical condition must meet ECOG performance status less than 2 (meaning you must be able to carry out light daily activities and be up and about more than 50% of waking hours)
Your heart function test must show pumping ability (ejection fraction) greater than 50%
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Your blood tests must show:
- White blood cells above 3.0
- Neutrophils (type of white blood cells) above 1.5
- Platelets above 100
- check
  Your liver function tests must be within certain limits:
  - Bilirubin less than 1.5 times the normal limit
  - Liver enzymes (AST/ALT) less than 2.5 times the normal limit (or less than 5 times if you have liver metastases)
  - Your kidney function (measured by creatinine clearance) must be above 30 ml/min

Who cannot join the trial?

14 criteria

Prior treatment with trastuzumab (a targeted therapy drug) for esophageal cancer
Known allergy or sensitivity to pembrolizumab (an immunotherapy drug) or its components
Active autoimmune disease requiring systemic treatment
Untreated brain metastases (cancer that has spread to the brain)
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Significant heart problems, including:
- Heart failure
- Uncontrolled high blood pressure
- Unstable heart rhythm disorders
- Active infection requiring systemic therapy
- Other active cancers requiring treatment
- Severe liver problems (liver function abnormalities)
- Severe kidney problems (impaired kidney function)
- Pregnancy or breastfeeding
- Unable to swallow oral medications
- Any condition that would make it unsafe to participate in the study, as determined by the study doctor

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Verified sites

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

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Aalborg University Hospital
Aalborg, Denmark
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Aarhus University Hospital
Aarhus, Denmark
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Odense University Hospital
Odense, Denmark

Trial locations

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Investigated drugs

Trastuzumab
is a targeted therapy medication used to treat cancers that have high levels of a protein called HER2. It works by attaching to HER2 proteins on cancer cells, helping to stop them from growing and spreading.
Pembrolizumab
is an immunotherapy medication that helps your immune system fight cancer cells. It works by blocking a protein that prevents your immune system from attacking cancer cells, allowing your body's natural defenses to work better against the disease.
Fluoropyrimidine
is a type of chemotherapy medication that works by interfering with cancer cell growth. It helps prevent cancer cells from making new DNA, which they need to multiply and spread.
Platinum
chemotherapy is a type of cancer treatment that damages the DNA inside cancer cells, preventing them from dividing and causing them to die. It is often used in combination with other cancer medications to increase effectiveness.

What is already known about the treatment

Trastuzumab
A targeted monoclonal antibody medication administered intravenously that specifically binds to HER2 protein on cancer cells. It is widely used in clinical practice and extensively documented in medical literature for treating HER2-positive cancers. The medication works by attaching to HER2 receptors on cancer cells, blocking their growth signals and flagging them for destruction by the immune system. It belongs to the class of targeted biological therapies known as HER2 inhibitors.
Pembrolizumab
An immunotherapy medication given through intravenous infusion that helps the immune system detect and fight cancer cells. It is well-established in clinical practice and has extensive research backing its use in various cancer types. The medication works by blocking the PD-1 protein on immune cells, which enables them to better recognize and attack cancer cells. It belongs to the class of immunotherapy drugs known as PD-1 inhibitors or checkpoint inhibitors.
Fluoropyrimidine
A type of chemotherapy medication that can be administered orally or intravenously, commonly used in combination with other cancer treatments. It is a well-established standard treatment in oncology, particularly for gastrointestinal cancers. The medication works by interfering with DNA synthesis in rapidly dividing cells, preventing cancer cells from multiplying. It belongs to the antimetabolite class of chemotherapy drugs.

Investigated diseases

Esophageal Cancer - A disease that develops in the esophagus, the muscular tube that connects the throat to the stomach. The cancer typically begins in the cells that line the inside of the esophagus, gradually growing through the esophageal wall layers. It can develop anywhere along the length of the esophagus and may cause difficulty swallowing, chest pain, or unintended weight loss. The condition more commonly affects the lower portion of the esophagus, where the esophagus joins the stomach. This type of cancer can change how the esophagus functions, affecting the normal passage of food and liquids.