Recruiting

Study on Adding Trastuzumab and Pertuzumab to Treatment for Patients with Resectable HER2 Positive Esophageal Cancer

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called HER2-positive esophageal adenocarcinoma. This is a cancer that affects the esophagus, which is the tube that carries food from the mouth to the stomach. The study is investigating the effects of adding two medications, trastuzumab and pertuzumab, to the usual treatment of chemotherapy and radiation before surgery. These medications are given as a solution through an infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to see if adding trastuzumab and pertuzumab can help improve the overall survival of patients with this type of cancer. Participants in the study will receive either the standard treatment or the standard treatment plus the two additional medications. Some participants may receive a placebo instead of the additional medications. The study will follow participants over a period of time to monitor their health and the effectiveness of the treatment.

Throughout the study, researchers will look at various outcomes, including how long patients live, how well the cancer responds to treatment, and the quality of life of the participants. The study will also assess the safety of the treatment by monitoring any side effects or complications that may occur. The goal is to gather information that could lead to better treatment options for people with HER2-positive esophageal adenocarcinoma in the future.

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
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including age, tumor characteristics, and overall health status.
Written informed consent is required to participate in the study.
Step 2
Initial assessment
An initial assessment is conducted to evaluate the health status and confirm the presence of HER2 positive esophageal adenocarcinoma.
This includes various tests to ensure the patient is fit for the treatment plan.
Step 3
Treatment phase
The treatment involves the administration of two medications: trastuzumab and pertuzumab.
These medications are given as a solution for infusion, which means they are administered directly into the bloodstream through an intravenous infusion.
The specific dosage and frequency of administration are determined by the healthcare team based on individual patient needs.
Step 4
Monitoring and follow-up
Regular monitoring is conducted to assess the response to treatment and manage any side effects.
Follow-up appointments are scheduled to evaluate the progress and adjust the treatment plan if necessary.
Step 5
Completion of treatment
Upon completion of the treatment phase, a final assessment is conducted to determine the overall response to the therapy.
The study aims to improve overall survival and assess other outcomes such as quality of life and treatment safety.

Who can join the trial?

15 criteria

The patient must have a type of cancer called **adenocarcinoma** in the esophagus or where the esophagus meets the stomach. This cancer must be at a specific stage, either T1N+M0 or T2-T4a N0 or N+ M0.
The cancer must be **HER2-positive**, which means it has a specific protein that can be detected by tests. This is confirmed by a local lab and checked by a central lab.
The cancer must be able to be removed by surgery, as decided by a team of doctors. If the tumor is too large to be examined with a special tube called an endoscope, it can still be eligible if other conditions are met.
If the cancer spreads below the area where the esophagus meets the stomach, most of the tumor must still be in the esophagus or the junction area.
The patient must be at least 18 years old.
The patient must be healthy enough to undergo a surgery called **esophagectomy**, which involves removing part of the esophagus.
The patient must have good blood, kidney, and liver function, as shown by specific medical tests:
**Neutrophils** (a type of white blood cell) must be at least 1.5 x 10⁹/L.
**Platelets** (cells that help blood clot) must be at least 100 x 10⁹/L.
**Hemoglobin** (a protein in red blood cells) must be at least 5.6 mmol.
**Total bilirubin** (a substance made by the liver) must be no more than 1.5 times the normal limit.
**Creatinine** (a waste product in the blood) must be less than 150 μmol/L, or the **creatinine clearance** (a test of kidney function) must be at least 50 ml/min.
The patient must have a healthy heart, with a **left ventricular ejection fraction** (a measure of heart function) of at least 50%, determined by a heart ultrasound or a MUGA scan.
The patient must provide written, voluntary consent to participate in the study.
The patient must be able to attend follow-up appointments and receive treatment at the study center.

Who cannot join the trial?

5 criteria

Patients who do not have **HER2 positive esophageal adenocarcinoma** cannot participate. This is a specific type of cancer in the esophagus that tests positive for a protein called HER2.
Patients who are not within the specified age range cannot participate. The age range is typically defined in the study details.
Patients who are not able to undergo surgery to remove the cancer cannot participate. "Resectable" means the cancer can be surgically removed.
Patients who are not eligible for the standard treatment for this type of cancer cannot participate. "Standard of care" refers to the usual treatment given for a condition.
Patients who are part of a vulnerable population, such as those unable to give consent, are not included in this study.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Amsterdam UMC
Responsive
Amsterdam, The Netherlands
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Responsive
Rotterdam, The Netherlands
Leids Universitair Medisch Centrum (LUMC)
Responsive
Leiden, The Netherlands

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Trastuzumab
is a medication used in this trial to target and block the HER2 protein, which can promote the growth of cancer cells. By blocking this protein, trastuzumab helps to slow down or stop the growth of cancer cells in patients with HER2-positive esophageal adenocarcinoma.
Pertuzumab
is another medication used in the trial that also targets the HER2 protein. It works in a similar way to trastuzumab but binds to a different part of the HER2 protein. When used together, pertuzumab and trastuzumab provide a more comprehensive blockade of the HER2 protein, potentially improving the effectiveness of the treatment in stopping cancer cell growth.

What is already known about the treatment

Trastuzumab
This medication is administered intravenously and is used in combination with other treatments for HER2 positive esophageal adenocarcinoma. It is well-established in medical literature as a targeted therapy for cancers that overexpress the HER2 protein. Trastuzumab works by binding to the HER2 receptors on the surface of cancer cells, inhibiting their growth and survival. It is classified as a monoclonal antibody and is commonly used in the treatment of certain types of breast and gastric cancers.
Pertuzumab
This medication is also administered intravenously and is used alongside trastuzumab and chemotherapy for treating HER2 positive esophageal adenocarcinoma. Pertuzumab is recognized in medical literature as a targeted therapy that enhances the effects of trastuzumab. It works by binding to a different part of the HER2 receptor, preventing the receptor from pairing with other HER family members, which inhibits cancer cell growth. Pertuzumab is classified as a monoclonal antibody and is used in combination with other drugs for treating HER2 positive breast cancer.

Investigated diseases

HER2 Positive Esophageal Adenocarcinoma – This is a type of cancer that occurs in the esophagus, the tube that carries food from the throat to the stomach. It is characterized by the overexpression of the HER2 protein, which promotes the growth of cancer cells. This form of adenocarcinoma typically begins in the glandular cells of the esophagus and can lead to difficulty swallowing, weight loss, and chest pain as it progresses. The disease may spread to nearby lymph nodes and other parts of the body if not managed. It is often diagnosed in the later stages due to subtle early symptoms. The progression of the disease can vary, with some cases advancing more rapidly than others.