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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 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 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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

13 criteria

  • 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 trial?

6 criteria

  • 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.
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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.

What is already known about the treatment

Trastuzumab Deruxtecan – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating HER2 positive resectable esophagogastric adenocarcinoma. It is a promising treatment option in the field of oncology, with ongoing research evaluating its safety and activity in combination therapies. The main therapeutic indication is for patients with HER2 positive, locally advanced, resectable esophagogastric adenocarcinoma. At the molecular level, trastuzumab deruxtecan works by targeting the HER2 protein on cancer cells, delivering a cytotoxic agent directly to the tumor, which helps to inhibit cancer cell growth. It is classified as an antibody-drug conjugate, combining targeted therapy with chemotherapy.

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-518841-12-00Protocol codeNeoARTEstimated enrolment39 patientsSponsorFrankfurter Institut Fuer Klinische Krebsforschung IKF GmbH

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).