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Phase II study of tislelizumab plus drug combination as intensified neoadjuvant and adjuvant therapy for resectable esophageal adenocarcinoma patients

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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 patients with Esophageal adenocarcinoma. The purpose is to assess how often a strong pre‑surgery (neoadjuvant) and post‑surgery (adjuvant) approach can completely eliminate cancer cells. The treatment combines several chemotherapy medicines given by intravenous infusion (medicine delivered through a vein): fluorouracil, paclitaxel, levoleucovorin disodium, docetaxel, carboplatin, oxaliplatin, and calcium levofolinate pentahydrate. In addition, an immunotherapy drug that helps the immune system attack cancer, called tislelizumab, is also used.

Participants receive the medicines in several cycles before surgery, then undergo surgical removal of the tumor, and may receive additional cycles after surgery. Doctors monitor for side effects, check recovery, and examine the tissue removed at surgery to see if any cancer cells remain (a result called pathologic complete response). Follow‑up visits continue after treatment to observe overall health and any return of disease.

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

    Start of Neoadjuvant Treatment

    After you are enrolled, the medical team will schedule your first day of treatment. This day begins the neoadjuvant (pre‑surgery) phase, which combines chemotherapy and immunotherapy to shrink the tumor before surgery.

    You will receive a series of intravenous infusions. The medications and their doses are:

    Fluorouracil 5200 mg given as an injection,

    Paclitaxel 100 mg given as a solution for infusion,

    Levoleucovorin disodium 200 mg per square meter of body‑surface area,

    Carboplatin 2 units (dose expressed as “Other” in the protocol),

    Oxaliplatin 170 mg given as a solution for infusion,

    Docetaxel 100 mg given as a solution for infusion,

    Calcium levofolinate pentahydrate 200 mg per square meter of body‑surface area,

    And Tislelizumab 200 mg given as a solution for infusion.

    All drugs are administered through a vein (intravenous infusion) on the days specified by the study schedule.

  2. Step 2

    Continuation of Neoadjuvant Chemotherapy‑Immunotherapy

    You will return for additional infusion sessions according to the trial schedule. Each session repeats the same set of medications and doses listed in Step 1.

    The interval between sessions is defined by the study protocol, typically every one to three weeks, but the exact timing will be explained by the trial staff.

    During this period, you will be monitored for side effects and for the response of the tumor to the treatment.

  3. Step 3

    Chemoradiotherapy (CRT)

    After completing the planned cycles of chemotherapy and immunotherapy, you will undergo combined chemoradiotherapy.

    Chemoradiotherapy adds targeted radiation to the area of the tumor while you continue to receive selected chemotherapy agents as instructed by the protocol.

    The exact radiation dose and schedule are determined by the treating physicians and are part of the study regimen.

  4. Step 4

    Surgical Resection

    When the pre‑operative treatment is finished and the tumor has responded, you will be scheduled for surgery to remove the esophageal tumor.

    The goal of the surgery is to achieve an R0 resection, meaning no visible cancer remains at the edges of the removed tissue.

    Pathologic examination of the removed tissue will determine whether a complete response (no residual cancer cells) was achieved.

  5. Step 5

    Post‑Surgical Follow‑Up and Adjuvant Therapy

    After surgery, you will enter a follow‑up period during which you will be evaluated for recovery and for any signs of disease recurrence.

    If the study protocol includes additional (adjuvant) therapy, you will receive further intravenous infusions of the same drugs at the doses described in Step 1, following the schedule defined by the investigators.

    Regular visits will include physical examinations, imaging studies, and quality‑of‑life questionnaires to assess long‑term outcomes.

Who can join the trial?

13 criteria

  • Be able to understand, sign, and date the written informed consent and follow all scheduled visits, tests, and study procedures.
  • Have adequate liver function, meaning the blood level of bilirubin (a substance made by the liver) is no more than 1.5 times the normal upper limit, and the liver enzymes AST and ALT are no more than 2.5 times normal.
  • Have adequate kidney function, measured by an estimated creatinine clearance greater than 30 mL/min (a test that shows how well the kidneys filter waste).
  • Not have a complete deficiency of the enzyme DPYD (which helps break down certain chemotherapy drugs); having a partial deficiency is allowed but may require a lower drug dose.
  • Use effective birth control for women who could become pregnant and for men with partners who could become pregnant, using either two barrier methods or one barrier method combined with a spermicide, intrauterine device, or oral contraceptive, during the study and for at least two months after the last dose.
  • Be 18 years of age or older, regardless of gender.
  • Have a confirmed diagnosis of esophageal or gastro‑esophageal junction adenocarcinoma verified by tissue testing.
  • Have a tumor that is locally advanced but can be removed with the Ivor Lewis procedure (a type of surgery that removes part of the esophagus).
  • Have cancer staging defined by imaging or endoscopy as cN1‑2 or cT2‑3 cN0‑2, with no distant spread (M0) according to the 8th edition of the TNM classification (a system that describes tumor size and spread).
  • Be treatment naive, meaning no prior cancer therapy has been given.
  • Have the tumor’s resectability confirmed by a multidisciplinary medical team.
  • Have an ECOG performance status of 0 or 1 (a scale that measures how well a person can carry out daily activities).
  • Have adequate blood counts: white blood cells ≥ 2.5 × 10⁹/L, neutrophils ≥ 1.5 × 10⁹/L, lymphocytes ≥ 0.5 × 10⁹/L, platelets ≥ 100 × 10⁹/L, and hemoglobin ≥ 9 g/dL (blood may have been transfused if needed).

Who cannot join the trial?

15 criteria

  • If scans (such as a CT scan or PET scan) show that the cancer has spread to distant parts of the body, you cannot join the study.
  • If you are taking medicines that suppress the immune system (for example, steroids) and cannot stop them, you are not eligible, except for very low‑dose steroid use (≤ 10 mg of prednisone per day) for specific conditions.
  • If you have an active autoimmune disease (a condition where the body attacks its own tissues) that could get worse with an immune‑boosting treatment, you cannot participate.
  • If you have significant heart or blood‑vessel problems, such as a stroke or heart attack within the past 6 months, unstable chest pain, moderate to severe heart failure, or uncontrolled serious heart rhythm problems, you are excluded.
  • If you have a known severe allergy (hypersensitivity) to the study drug or any of its ingredients, you cannot be enrolled.
  • If you currently have problems with alcohol or drug misuse, you are not eligible.
  • If personal, family, social, or travel circumstances would make it difficult for you to follow the study schedule and attend follow‑up visits, you cannot take part.
  • If you have already received radiation therapy to the chest (mediastinal) or abdomen that would overlap with the planned treatment, you are excluded.
  • If you have already received any cancer treatment (such as surgery, chemotherapy, or radiation) for this esophageal tumor, you cannot join.
  • If you have had another type of cancer in the past five years, except for certain skin cancers, early‑stage cervical cancer, non‑metastatic prostate cancer, or another cancer that has been completely cured and relapse‑free for at least three years, you are not eligible.
  • If you have a genetic condition that causes a complete lack of the DPD enzyme (which affects how some chemotherapy drugs are processed), you cannot participate.
  • If you are currently pregnant or breastfeeding, you are excluded.
  • If you have moderate or more severe nerve damage (neuropathy) from other health problems (grade higher than 1 on a standard scale), you cannot join.
  • If you have taken part in another drug trial or received experimental medication within the last 30 days, you are not eligible (observational studies without treatment are allowed).
  • If you have a serious active infection, such as a known positive test for HIV/AIDS or other significant acute or chronic infections, you cannot participate.
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Investigated drugs

  • Fluorouracil

    is a chemotherapy drug that stops cancer cells from making DNA, which they need to grow and divide. In this study it is given through an IV to try to shrink the tumor before surgery.

  • Paclitaxel

    is a chemotherapy medicine that blocks the ability of cancer cells to separate during division. It is given by IV infusion and works together with other drugs to attack the tumor before it is removed.

  • Levoleucovorin

    (also called folinic acid) is not a cancer‑killing drug but a protective agent. It is given through an IV to help reduce the side effects of fluorouracil and make the chemotherapy safer for the patient.

  • Docetaxel

    is a chemotherapy medication similar to paclitaxel. It interferes with the microtubules that cancer cells need to split, helping to stop tumor growth when given by IV.

  • Tislelizumab

    is an immunotherapy drug that belongs to a class called PD‑1 inhibitors. It helps the body’s immune system recognize and attack cancer cells and is given by IV infusion as part of the treatment plan.

  • Carboplatin

    is a platinum‑based chemotherapy drug. It works by damaging the DNA inside cancer cells, making it harder for them to survive. It is administered through an IV as part of the combination therapy.

What is already known about the treatment

  • Fluorouracil

    It is given as an intravenous infusion injection. Fluorouracil is an established chemotherapy drug widely used and described in medical literature. It is mainly used to treat cancers such as esophageal adenocarcinoma by interfering with the building blocks of DNA, which stops cancer cells from growing. It belongs to the class of antimetabolite antineoplastic agents.

  • Paclitaxel

    Administered by intravenous infusion of a solution. Paclitaxel is a well‑known chemotherapy medicine that is approved and frequently referenced in research. It works by binding to and stabilizing micro‑tubules, preventing them from breaking down, which blocks cell division in tumors. It is classified as a taxane antineoplastic agent.

  • Levoleucovorin Disodium

    Given as an intravenous infusion solution. Levoleucovorin is an approved rescue agent used together with fluorouracil‑based chemotherapy to reduce side effects. It supplies a form of folate that helps normal cells repair DNA, lessening toxicity without affecting the cancer‑killing action. It is categorized as a detoxifying agent for antineoplastic treatment.

  • Docetaxel

    Provided as an intravenous infusion solution. Docetaxel is a standard chemotherapy drug that appears in many clinical studies. It promotes the assembly of micro‑tubules and prevents their disassembly, which stops cancer cells from dividing. It belongs to the taxane class of antineoplastic agents.

  • Tislelizumab

    Administered by intravenous infusion of a concentrated solution. Tislelizumab is a newer monoclonal antibody that has received regulatory approval and is described in recent oncology literature. It blocks the PD‑1 protein on immune cells, helping the body’s immune system recognize and attack tumor cells. It is classified as a PD‑1 immune checkpoint inhibitor.

  • Carboplatin

    Delivered as an intravenous infusion solution. Carboplatin is an established platinum‑based chemotherapy drug widely used and well documented. It creates cross‑links in DNA strands, which prevents cancer cells from copying their genetic material and leads to cell death. It is classified as a platinum compound antineoplastic agent.

Investigated diseases

Esophageal adenocarcinoma - A cancer that starts in the glandular cells lining the lower part of the esophagus, often where acid reflux has caused changes in the tissue. It begins as a small abnormal growth that can grow deeper into the wall of the esophagus. Over time the tumor may spread to nearby lymph nodes and surrounding structures. If it continues to advance, cancer cells can travel through the bloodstream to distant organs such as the liver or lungs. The disease typically progresses from a localized stage to more extensive involvement if not halted.
Trial detailsLast updated 12 Nov 2026
Age18+ yearsPhasePhase IITrial ID2026-526333-25-00Protocol codeDREAMEREstimated enrolment113 patientsSponsorCentro Di Riferimento Oncologico Di Aviano

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