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Durvalumab plus drug combination as total neoadjuvant therapy for patients with resectable gastroesophageal adenocarcinoma

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What is this trial about?

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

The study focuses on Gastroesophageal Adenocarcinoma, a type of cancer that starts in the lining of the stomach or the lower part of the esophagus. The treatment being tested combines a chemotherapy mixture called FLOT – which includes the medicines fluorouracil, calcium folinate, oxaliplatin and docetaxel – with an immunotherapy drug named durvalumab (brand name IMFINZI). Chemotherapy uses strong medicines to kill cancer cells, while immunotherapy helps the body’s own immune system recognize and attack the cancer.

The purpose of the study is to evaluate the efficacy of this total neoadjuvant treatment approach. Participants first receive the combined chemotherapy and immunotherapy before any surgery (this is called “neoadjuvant” treatment, meaning before the operation). After the tumor is surgically removed, they continue to receive durvalumab as additional (“adjuvant”) therapy to try to keep the cancer from returning.

During the trial, doctors will check whether the cancer is completely gone in the tissue removed at surgery, monitor how long patients stay free of disease, and record any side effects. Simple explanations are provided for any medical terms, such as “neoadjuvant” meaning treatment given before surgery and “adjuvant” meaning treatment given after surgery. The study follows participants for several years to see how well the treatment works and how safe it is.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline assessments

    After joining the trial you will undergo initial medical examinations, blood tests, and imaging studies to confirm eligibility and to record the status of the gastroesophageal adenocarcinoma.

    The results are used to plan the upcoming treatment schedule.

  2. Step 2

    Start of neoadjuvant treatment

    The first phase is called neoadjuvant treatment, which means therapy given before surgery to shrink the tumor.

    You will receive an infusion that combines four chemotherapy drugs, known as the flot regimen:

    fluorouracil 2600 mg/m2, calcium folinate 200 mg/m2, oxaliplatin 85 mg/m2, and docetaxel 50 mg/m2. each drug is given through a vein (intravenous infusion).

    In the same infusion session you will also receive durvalumab 1500 mg, an immunotherapy drug that helps the immune system recognize cancer cells.

  3. Step 3

    Repeated neoadjuvant cycles

    The combination infusion described above is repeated for several cycles as defined by the trial protocol.

    Each cycle is administered on a scheduled day, and you will be monitored with blood tests and clinical checks before every new infusion.

  4. Step 4

    Pre‑surgery evaluation

    After completing the planned neoadjuvant cycles, additional imaging and clinical assessments are performed to evaluate the response of the tumor.

    These evaluations determine whether you are ready for the surgical procedure.

  5. Step 5

    Surgical removal of the tumor

    You will undergo surgery to remove the gastroesophageal tumor. the goal is to achieve an r0 resection, meaning no cancer cells are left at the surgical margins.

    Standard postoperative care is provided according to hospital practice.

  6. Step 6

    Postoperative durvalumab treatment

    Following recovery from surgery, you will start the postoperative phase, which consists of additional infusions of durvalumab 1500 mg.

    The number of postoperative durvalumab infusions and the total treatment period are defined by the trial protocol.

  7. Step 7

    Follow‑up monitoring

    Throughout the postoperative period and after the last durvalumab infusion, you will have regular follow‑up visits that include physical examinations, imaging studies, and questionnaires about quality of life.

    These visits are used to assess long‑term outcomes such as event‑free survival, overall survival, and any side effects.

Who can join the trial?

17 criteria

  • You must sign a written informed consent form agreeing to take part in the study.
  • If you are a woman who could become pregnant, you must agree to avoid pregnancy by using birth control methods that have less than a 1% chance of failure and also use a barrier method (such as a condom) during treatment and for the required time after treatment.
  • If you are a man whose partner could become pregnant, you must agree to avoid pregnancy by using a barrier method (such as a condom) during treatment and for the required time after treatment, and you must not donate sperm during that period.
  • You must be willing and able to follow all study procedures, including taking the medication and attending scheduled visits and tests.
  • You must be at least 18 years old when you sign the consent form.
  • You must have a diagnosis of gastroesophageal adenocarcinoma that has been confirmed by a tissue test (histology) and is at a stage that can be removed by surgery (resectable) and is considered locally advanced (tumor has grown into nearby tissues but has not spread to distant organs).
  • Your tumor must have a known PD‑L1 status, which is a lab test that looks at a protein on cancer cells; any result is allowed.
  • Your overall health must be rated as 0 or 1 on the ECOG performance status scale, which measures how well you can carry out daily activities (0 = fully active, 1 = restricted but able to do light work).
  • You must be expected to live at least 12 more weeks (life expectancy).
  • Your blood tests must show:
    • an absolute neutrophil count (ANC) of at least 1.0 × 10⁹ cells per litre,
    • a platelet count of at least 75 × 10⁹ per litre (75,000 per mm³),
    • hemoglobin of at least 9 g/dL,
    • total bilirubin no more than 1.5 times the normal upper limit,
    • liver enzymes (AST/ALT) no more than 2.5 times the normal upper limit,
    • if you are not on blood thinners, an INR and aPTT each no more than 1.5 times the normal limit (or stable therapeutic levels if you are on blood thinners for at least three weeks),
    • creatinine (a kidney test) no more than 1.5 times the normal limit and a calculated creatinine clearance greater than 40 mL per minute.
    • You must weigh more than 30 kg (about 66 lb).

Who cannot join the trial?

27 criteria

  • Received any previous chemotherapy, radiation therapy, or checkpoint‑inhibitor drugs (a type of immunotherapy) for this cancer or any other cancer within the last five years.
  • Has pernicious anemia or another large‑cell anemia caused by a lack of vitamin B12.
  • Has peripheral sensory neuropathy that causes numbness, tingling, or weakness and limits daily activities.
  • Had a myocardial infarction (heart attack) in the past six months, or has symptomatic congestive heart failure (NYHA class II‑IV); also, if heart‑damage markers (troponin) are high at screening, a heart‑doctor review is required.
  • Shows a prolonged QTc interval on an ECG (greater than 470 ms for women or 450 ms for men).
  • Has another active cancer (malignancy) that is not one of the allowed cured cancers or specific skin cancers.
  • Has an uncontrolled infection that required IV antibiotics, antivirals, or antifungals within the past 14 days.
  • Has active HBV (hepatitis B) infection—positive surface antigen or core antibodies with detectable viral DNA—unless already on approved antiviral treatment.
  • Has active HCV (hepatitis C) infection—detectable viral RNA and antibodies—unless managed according to study rules.
  • Has a co‑infection with hepatitis B and hepatitis D (positive HDV antibodies).
  • Has active tuberculosis infection, confirmed by history, exam, imaging, or testing.
  • Has previously had any partial or complete removal of the esophagus or stomach tumor.
  • Has HIV infection that is not well controlled (viral load not undetectable, CD4 count below 350 cells/mm³, recent serious infections, or unstable medication regimen).
  • Has an active autoimmune disease (such as myasthenia gravis, lupus, rheumatoid arthritis, inflammatory bowel disease, etc.) that has required treatment in the past five years, except for mild conditions like vitiligo, stable hypothyroidism, or diet‑controlled celiac disease.
  • Is currently taking or has taken immunosuppressive medication within 14 days before the first dose, except for low‑dose steroids or local steroid use.
  • Received a live, weakened (attenuated) vaccine within 30 days before starting the study drug.
  • Has any other serious medical condition that the investigator believes makes participation too risky.
  • Participated in another interventional clinical trial or was receiving another trial drug within 28 days before enrollment (observational studies are allowed).
  • Has taken any investigational (non‑approved) drug within 28 days before starting the study medication.
  • Is a female who is pregnant, breastfeeding, or planning to become pregnant within six months after treatment ends, or who does not have a negative pregnancy test within seven days before starting the study.
  • Has known hypersensitivity (allergy) to any part of the study drug durvalumab or severe allergic reactions to similar antibody medicines.
  • Has a history of non‑infectious lung inflammation such as pneumonitis or interstitial lung disease that required steroids, or currently has these conditions.
  • Has other serious lung problems, including recent pulmonary emboli (blood clot in the lung) within three months, severe asthma, severe COPD (chronic obstructive pulmonary disease), restrictive lung disease, or fluid around the lungs (pleural effusion).
  • Has previously undergone a complete removal of a lung (pneumonectomy).
  • Has inadequate heart pumping ability, defined as a left ventricular ejection fraction (LVEF) below 50% on an echocardiogram.
  • Has a complete lack of DPD activity (the enzyme dihydropyrimidine dehydrogenase needed to process certain chemotherapy drugs).
  • Has taken brivudine, sorivudine, or similar antiviral medicines within 28 days before enrollment.
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Investigated drugs

  • 5-FU

    is a chemotherapy drug that stops cancer cells from making DNA, which they need to grow. In this trial it is given as part of the FLOT combination before surgery to shrink the tumor.

  • Calcium Folinate

    is a medication that is used together with 5‑FU. It helps the chemotherapy work better and can reduce some side effects, making the treatment more effective during the pre‑surgery phase.

  • Oxaliplatin

    is a platinum‑based chemotherapy. It damages the DNA inside cancer cells, causing them to die. It is one of the four drugs in the FLOT regimen that patients receive before their operation.

  • Docetaxel

    is a chemotherapy drug that stops cancer cells from dividing. It is included in the FLOT combination given before surgery to attack the tumor from a different angle.

  • Durvalumab

    (brand name IMFINZI) is an immunotherapy that helps the body’s immune system recognize and attack cancer cells. In this study it is given together with the FLOT chemotherapy before surgery and then again after surgery to try to keep the cancer from coming back.

What is already known about the treatment

  • Fluorouracil

    This medication is supplied as a solution for injection and is given by intravenous infusion. It is a long‑standing chemotherapy drug that is widely used and well described in medical literature for treating many solid tumors, especially cancers of the gastrointestinal tract. Fluorouracil works by mimicking a building block of DNA, which blocks the cancer cell’s ability to make new DNA and leads to cell death. It belongs to the antimetabolite class of anticancer agents.

  • Calcium Folinate

    Calcium folinate is provided as an injectable solution and is administered together with other drugs by intravenous infusion. It is an established agent that is routinely used to boost the effect of fluorouracil in cancer treatment and is well documented in clinical practice. The compound supplies a form of folate that helps bind fluorouracil to its target enzyme, making the chemotherapy more effective. It is classified as a folate rescue or enhancement agent.

  • Oxaliplatin

    Oxaliplatin comes as a concentrate for solution and is given by intravenous infusion. It is an approved chemotherapy drug with extensive use in colorectal and other gastrointestinal cancers, and its safety and efficacy are well recorded in the literature. The drug attaches to DNA strands and creates cross‑links that prevent the DNA from separating, which stops cancer cells from dividing. Oxaliplatin is classified as a platinum‑based anticancer agent.

  • Durvalumab

    Durvalumab is supplied as a concentrate for infusion and is administered intravenously. It is an approved immune‑checkpoint inhibitor that has been studied in several cancers and is now being evaluated for gastroesophageal adenocarcinoma. The medication blocks the PD‑L1 protein on tumor cells, allowing the body’s immune system to recognize and attack the cancer. It belongs to the class of monoclonal antibodies that inhibit PD‑L1.

  • Docetaxel

    Docetaxel is provided as a concentrate for solution and is given by intravenous infusion. It is a well‑known chemotherapy drug used for many solid tumors, including stomach and esophageal cancers, with a solid record in medical research. The drug stabilizes the microtubule structures inside cells, preventing them from breaking down, which stops cancer cells from completing division. Docetaxel is classified as a taxane, a microtubule‑stabilizing agent.

Investigated diseases

Gastroesophageal adenocarcinoma - It is a cancer that starts in the glandular cells lining the lower part of the esophagus and the upper part of the stomach. The tumor often begins as a small abnormal area that can grow larger over time. As it expands, it may spread into the deeper layers of the wall and reach nearby lymph nodes. The disease can also extend upward into the esophagus or downward into the stomach. If it continues to grow, cancer cells may travel to other organs through the bloodstream or lymphatic system.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-525185-21-00Protocol codeIKF-099/D-FLOT-TNTEstimated enrolment101 patientsSponsorInstitut fuer Klinische Krebsforschung IKF GmbH

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