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Study of Atezolizumab and Tiragolumab for Patients with Unresectable Esophageal Squamous Cell Carcinoma After Chemoradiotherapy

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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 Unresectable Esophageal Squamous Cell Carcinoma. This is a condition where cancer cells form in the tissues of the esophagus, and the cancer cannot be removed by surgery. The study is testing the effectiveness of two treatments: Atezolizumab and Tiragolumab. Atezolizumab is a medication that helps the immune system attack cancer cells, while Tiragolumab is an experimental drug that may enhance the effects of Atezolizumab. Some participants will receive both Atezolizumab and Tiragolumab, while others will receive Atezolizumab with a placebo, or a double placebo.

The purpose of the study is to evaluate how well these treatments work in preventing the cancer from getting worse and in improving the overall survival of patients. Participants in the study will receive their treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will last for a period of up to 51 weeks, during which participants will be closely monitored by healthcare professionals. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication and who is receiving the placebo, to ensure unbiased results.

Throughout the study, participants will undergo regular check-ups and tests to assess their health and the progress of their cancer. The main goal is to see if the combination of Atezolizumab and Tiragolumab can help patients live longer and keep their cancer from progressing compared to those receiving the placebo. This study is an important step in finding more effective treatments for people with this type of esophageal cancer.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient is randomly assigned to one of the treatment groups. This process is called randomization and ensures that each participant has an equal chance of receiving any of the treatments being tested.

  2. Step 2

    Treatment administration

    The patient receives treatment through an IV infusion, which is a method of delivering medication directly into the bloodstream through a vein.

    The medications involved in the study are tiragolumab and atezolizumab. Tiragolumab is an experimental drug, while atezolizumab is a medication used to help the immune system attack cancer cells.

    The specific dosage and frequency of administration are determined by the study protocol and may vary depending on the treatment group to which the patient is assigned.

  3. Step 3

    Monitoring and assessments

    Throughout the study, the patient's health and response to treatment are closely monitored. This includes regular medical assessments and tests to evaluate the effectiveness of the treatment and to check for any side effects.

    The primary goals are to assess progression-free survival and overall survival, which measure how long the patient lives without the cancer worsening and the overall length of survival, respectively.

  4. Step 4

    Completion of the study

    The study is expected to continue until January 31, 2027. Upon completion, the data collected will be analyzed to determine the effectiveness and safety of the treatments.

    The patient may continue to receive follow-up care as needed, based on the results of the study and their individual health needs.

Who can join the trial?

13 criteria

  • Must have a confirmed diagnosis of **squamous cell carcinoma** of the esophagus. This means a specific type of cancer in the esophagus has been identified through tests.
  • Must have received a specific treatment called **definitive concurrent chemoradiotherapy (dCRT)**, which combines chemotherapy and radiation therapy, according to regional cancer treatment guidelines.
  • For patients with inoperable cancer, they must have completed at least 2 cycles of **platinum-based chemotherapy** and radiation therapy without the cancer getting worse, as shown by scans.
  • Patients with cancer in the neck area of the esophagus may receive a higher dose of radiation, as per local guidelines.
  • Must be randomized into the study within 1 to 84 days after the last dose of radiation therapy.
  • Must stop using herbal therapies or traditional Chinese medicines intended to treat the cancer before joining the study.
  • Must have **Stage II-IVA** cancer, which means the cancer is locally advanced and cannot be removed by surgery. This is determined by a medical professional.
  • Patients with **Stage IVB** cancer in the neck or upper chest area, with cancer spread only to certain lymph nodes, may be eligible if deemed suitable for the specific treatment by their doctor.
  • Must provide a sample of the tumor tissue that is less than 12 months old for testing. This sample should be of good quality and include a pathology report.
  • Patients whose tumor tissue cannot be evaluated for a specific test called **PD-L1 expression** are not eligible.
  • Must not have an active **hepatitis B virus (HBV)** infection, or if they do, the virus level must be below a certain amount. If the virus is detectable, treatment should start at least 14 days before the study.
  • Must have a negative test for **hepatitis C virus (HCV)**, or if the first test is positive, a follow-up test must be negative.
  • Both male and female patients are eligible to participate.

Who cannot join the trial?

10 criteria

  • Patients with other types of cancer that are not the specific type being studied.
  • Patients who have had previous treatment with the same drugs being tested in the study.
  • Patients with serious heart problems, such as heart failure or a recent heart attack.
  • Patients with uncontrolled high blood pressure, which means their blood pressure is not well managed with medication.
  • Patients with active infections that require treatment with antibiotics or other medications.
  • Patients who are pregnant or breastfeeding, as the study drugs may affect the baby.
  • Patients with a history of severe allergic reactions to similar drugs.
  • Patients with autoimmune diseases, which are conditions where the immune system attacks the body's own tissues.
  • Patients who are currently participating in another clinical trial.
  • Patients with severe liver or kidney disease, which means their liver or kidneys are not working well.
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Investigated drugs

  • Atezolizumab

    is a medication used in this trial to help the immune system fight cancer. It works by blocking a protein that can stop the immune system from attacking cancer cells, allowing the immune system to better target and destroy these cells.

  • Tiragolumab

    is an experimental medication being tested in this trial. It is designed to enhance the immune system's ability to fight cancer by targeting a specific protein that may help cancer cells evade the immune response. This medication is being studied to see if it can improve the effectiveness of atezolizumab in treating esophageal squamous cell carcinoma.

What is already known about the treatment

  • Atezolizumab

    Atezolizumab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating unresectable esophageal squamous cell carcinoma. It is an approved medication in the field of oncology and is well-documented in medical literature. The main therapeutic indication for atezolizumab is to help the immune system attack cancer cells. It works by blocking a protein called PD-L1, which can prevent the immune system from attacking cancer cells. Atezolizumab is classified as an immune checkpoint inhibitor.

  • Tiragolumab

    Tiragolumab is also administered intravenously and is under investigation in clinical trials for its potential use in treating unresectable esophageal squamous cell carcinoma. It is not yet approved for general medical use and is primarily discussed in the context of ongoing research. The main therapeutic indication is to enhance the immune response against cancer cells. Tiragolumab works by targeting the TIGIT protein, which can suppress the immune system's ability to fight cancer. It is classified as an immune checkpoint inhibitor.

Investigated diseases

Unresectable Esophageal Squamous Cell Carcinoma – This is a type of cancer that forms in the cells lining the esophagus, which is the tube that carries food from the throat to the stomach. The term "unresectable" means that the cancer cannot be removed completely through surgery. It typically progresses by growing deeper into the esophageal wall and may spread to nearby lymph nodes or other parts of the body. As the disease advances, it can cause symptoms such as difficulty swallowing, weight loss, and chest pain. The progression of this cancer can lead to a narrowing of the esophagus, making it challenging for patients to eat or drink.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502052-30-00Protocol codeYO42137Estimated enrolment757 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

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