Study on the Safety and Effectiveness of Trastuzumab Deruxtecan with Drug Combination for Patients with HER2+ Resectable Esophagogastric Cancer

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What is this study about?

This clinical trial is focused on studying a type of cancer called HER2-positive esophagogastric adenocarcinoma, which affects the esophagus and stomach. The study will explore the use of a treatment called trastuzumab deruxtecan, also known by its code name DS-8201a. This treatment will be combined with other medications, including fluorouracil, calcium folinate pentahydrate, and oxaliplatin. These medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to evaluate the safety and effectiveness of these combination therapies when given before surgery to patients with this type of cancer. The study will involve several phases, where participants will receive the treatment and be monitored for any side effects or changes in their condition. The goal is to determine if this combination of treatments can be safely administered and if it helps in reducing the cancer before surgery.

Participants in the study will receive either the combination of trastuzumab deruxtecan and other medications or a placebo. The study will track how well patients tolerate the treatment and any side effects they experience. The results will help researchers understand if this treatment approach is a viable option for patients with HER2-positive esophagogastric adenocarcinoma.

1 initiation of treatment

The treatment begins with the administration of trastuzumab deruxtecan (DS-8201a) through an intravenous infusion. This medication is specifically designed to target and treat HER2 positive esophagogastric adenocarcinoma.

The infusion is conducted under medical supervision to ensure safety and monitor any immediate reactions.

2 combination therapy

Following the initial treatment, a combination of medications is administered. This includes fluorouracil (5-FU medac 50 mg/ml) and calcium folinate pentahydrate (Leucovorin 10 mg/ml). Both are given as solutions for injection or infusion.

These medications are used to enhance the effectiveness of the treatment by interfering with the growth of cancer cells.

3 additional medication

The treatment regimen also includes oxaliplatin (Oxaliplatin Kabi 5 mg/ml), administered as a solution for infusion.

Oxaliplatin is a chemotherapy drug that works by damaging the DNA of cancer cells, preventing them from dividing and growing.

4 monitoring and assessment

Throughout the treatment, regular monitoring is conducted to assess the safety and effectiveness of the therapy. This includes checking for any adverse effects and evaluating the response of the cancer to the treatment.

The primary goal is to ensure that the treatment is feasible and safe, with a focus on minimizing any dose-limiting toxicities.

5 surgical evaluation

After completing the treatment regimen, an evaluation is conducted to determine the possibility of surgical removal of the tumor.

The aim is to achieve a complete removal of the cancerous tissue, known as an R0 resection, which indicates no cancer cells are left at the margins of the removed tissue.

Who Can Join the Study?

The patient must provide written informed consent, which means they agree to participate after understanding the study details.
The patient must be 18 years of age or older at the time of signing the consent form.
The patient must have a specific type of cancer called locally advanced esophagogastric adenocarcinoma, which is a cancer located in the stomach, where the esophagus meets the stomach, or the lower part of the esophagus. The cancer must be at a stage that can be surgically removed and should not have spread to distant areas in the abdomen.
The patient’s tumor must be HER2 positive, which means it has a high level of a protein called HER2. This is determined by specific tests.
The patient must have an ECOG performance status of 0 or 1, which indicates they are fully active or have some symptoms but can carry out light work.
The patient must have adequate blood health, liver function, and kidney function, which includes:
- A certain level of white blood cells without needing special medications.
- A platelet count that helps with blood clotting.
- A hemoglobin level that is sufficient for carrying oxygen in the blood.
- Liver enzymes and bilirubin levels within a specific range.
- If not on blood thinners, certain blood clotting tests must be within normal limits. If on blood thinners, the patient must be on a stable dose for at least three weeks.
- Kidney function tests must show a certain level of creatinine, which is a waste product filtered by the kidneys.
Female patients who can have children must agree to avoid pregnancy by using effective birth control methods during the study and for a period after the study ends.
Male patients with partners who can have children must agree to use barrier methods of birth control during the study and for a period after the study ends. They must also agree not to donate sperm during this time.

Who Cannot Join the Study?

Patients who do not have HER2 positive esophagogastric adenocarcinoma. HER2 positive means that the cancer cells have more of a protein called HER2, which can affect how the cancer grows.
Patients whose cancer is not resectable. Resectable means that the cancer can be removed by surgery.
Patients who do not have locally advanced cancer. Locally advanced means the cancer has spread to nearby areas but not to distant parts of the body.
Patients who are not within the specified age range for the study.
Patients who are not able to safely undergo the treatment regimens being tested in the study.
Patients who are part of a vulnerable population that the study is not designed to include.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Technische Universitaet Dresden	Dresden	Germany
Haematologisch Onkologische Praxis Eppendorf	Hamburg	Germany
Medical University Of Vienna	Vienna	Austria
University Hospital Jena KöR	Jena	Germany
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Universitaet Leipzig	Leipzig	Germany

Other Sites

Site Name	City	Country
Krankenhaus Nordwest GmbH	Frankfurt	Germany
Klinikum Nuernberg	Nürnberg	Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Klinikum Chemnitz gGmbH	Chemnitz	Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Uniklinikum Salzburg	Salzburg	Austria
Mgvexcvepgurhemomvphuxjmde Hudtvepbcqofvhyj	Halle (Saale)	Germany
Komcybls Etutwdbxfeywyupzbzmlphgj Hhahkpfhelqircmjb	Essen	Germany

Trial status

Country	Status	Recruitment Start
Austria	Not yet recruiting	01.02.2025
Germany	Not yet recruiting	01.02.2025

Trial locations

Investigated drugs:

Trastuzumab-deruxtecan is a medication used in this trial to treat patients with HER2 positive esophagogastric adenocarcinoma. It is a targeted therapy that combines an anti-HER2 antibody with a chemotherapy drug. This combination helps deliver the chemotherapy directly to the cancer cells, potentially improving the effectiveness of the treatment while minimizing damage to healthy cells.

Investigated diseases:

HER2 Positive Resectable Esophagogastric Adenocarcinoma – This is a type of cancer that occurs in the esophagus and stomach, characterized by the overexpression of the HER2 protein. It is considered resectable, meaning it can potentially be removed through surgery. The disease typically begins in the cells lining the esophagus or stomach and can grow to invade deeper layers and nearby structures. As it progresses, it may spread to nearby lymph nodes and other parts of the body. The presence of the HER2 protein can influence the growth and spread of the cancer cells. This condition is not classified as a rare disease.

Trial ID:

2024-518841-12-00

Protocol code:

NeoART

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effectiveness of Trastuzumab Deruxtecan with Drug Combination for Patients with HER2+ Resectable Esophagogastric Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?