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

2 1 1 1

What is this study about?

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.

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

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

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

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 Study?

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%
Your blood tests must show:
- White blood cells above 3.0
- Neutrophils (type of white blood cells) above 1.5
- Platelets above 100
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 Study?

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)
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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Odense University Hospital	Odense	Denmark
Aalborg University Hospital	Aalborg	Denmark
Rigshospitalet	Copenhagen	Denmark
Ayseer Udyultskem Hpaxybkf	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	21.02.2022

Trial locations

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.

Investigated diseases:

Oesophageal carcinoma

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.

Trial ID:

2024-516318-40-02

NCT ID:

NCT05170256

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?