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Study of Atezolizumab Combined with Radiotherapy in Patients with Operable Soft Tissue Sarcomas

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This clinical trial focuses on patients with soft tissue sarcoma, which is a type of cancer that develops in soft tissues like muscles, tendons, and fat. The study examines the effectiveness of combining radiotherapy with atezolizumab (also known as Tecentriq), a medication that helps the immune system fight cancer cells. The purpose is to evaluate how well this combination treatment works compared to using radiotherapy alone in patients who can undergo surgery.

The treatment involves receiving atezolizumab through an intravenous infusion. Patients will receive up to 1200 mg of the medication per day, with treatment lasting up to 12 months. Some patients will receive only radiotherapy, while others will receive both radiotherapy and atezolizumab. After the treatment period, all patients will undergo surgery to remove the tumor.

The study will look at how much of the tumor is destroyed by examining the tissue removed during surgery. Doctors will also monitor how the immune system responds to the treatment by studying various types of immune cells in the tumor tissue. Throughout the study, patients will have regular check-ups to monitor their health and any side effects from the treatment.

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

    Initial assessment

    Medical tests will be performed to check your eligibility, including blood tests to assess bone marrow, kidney, and liver function

    A tumor biopsy will be taken to confirm the diagnosis of soft tissue sarcoma

    The tumor must be at least 10 mm in diameter and suitable for biopsy

  2. Step 2

    Treatment assignment

    You will be randomly assigned to one of the treatment groups

    The study compares radiotherapy alone versus radiotherapy with immunotherapy or immunotherapy alone

  3. Step 3

    Treatment period

    If assigned to the immunotherapy group, you will receive Tecentriq (atezolizumab) through an IV infusion

    Radiotherapy will be administered according to the treatment plan if you are in a radiotherapy group

    Regular monitoring of your condition and any side effects will be conducted

  4. Step 4

    Surgery

    After completing the assigned treatment, surgery will be performed to remove the tumor

    The removed tissue will be examined to measure the response to treatment

    The main measure of success is achieving at least 80% tumor death in the removed tissue

  5. Step 5

    Follow-up period

    Your recovery will be monitored after surgery

    Regular check-ups will continue for at least one year after surgery

    The medical team will track any possible return of the cancer and your overall health status

Who can join the trial?

18 criteria

  • Age 18 years or older
  • Diagnosed with soft tissue sarcoma (a type of tumor that develops in soft tissues), including specific types such as liposarcoma, leiomyosarcoma, myxofibrosarcoma, and others, except for Ewing sarcoma, rhabdomyosarcoma, and myxoid liposarcoma
  • Tumor must be suitable for radiation therapy before surgery and can be surgically removed with the goal of cure
  • Must have at least one tumor measuring 10 mm or larger that can be safely biopsied
  • ECOG performance status of 0 or 1 (able to perform daily activities with minimal assistance)
  • Adequate blood test results showing:
    • Sufficient red blood cells (hemoglobin ≥ 9.0 g/dL)
    • Adequate white blood cells and platelets
    • Normal kidney function
    • Normal liver function
    • Normal blood clotting
    • Must not have received certain treatments within specific timeframes:
      • No immune-suppressing medications within 28 days
      • No live vaccines within 30 days
      • No major surgery within 14 days
      • No cancer treatments within 21 days
      • Women who can become pregnant must have a negative pregnancy test and use effective birth control during the study and for 5 months after
      • Men who can father children must use effective birth control during the study and for 5 months after
      • Must be willing to sign informed consent and follow study procedures
      • Must have medical insurance where applicable

Who cannot join the trial?

14 criteria

  • Age under 18 years old or over 65 years old
  • Pregnant or breastfeeding women
  • Previous treatment with radiotherapy in the area to be treated
  • Presence of metastatic disease (cancer that has spread to other parts of the body)
  • Active autoimmune disease requiring systemic treatment
  • Uncontrolled heart, lung, kidney, or liver disease
  • Known infection with HIV, Hepatitis B, or Hepatitis C
  • History of other cancer within the last 5 years (except adequately treated non-melanoma skin cancer)
  • Inability to undergo MRI scanning (such as having metal implants or claustrophobia)
  • Psychological, family, social, or geographical conditions that could interfere with study participation
  • Participation in another clinical trial within the last 30 days
  • Known allergy or hypersensitivity to study medications
  • Use of systemic corticosteroids (medications that reduce inflammation) or other immunosuppressive medications
  • Active or chronic infection requiring treatment
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Investigated drugs

Atezolizumab is a type of immunotherapy medication that works by targeting a protein called PD-L1 on cancer cells. It helps the body's immune system recognize and fight cancer cells. This medication belongs to a group of drugs called immune checkpoint inhibitors. It is given through an intravenous infusion (through a vein). Radiotherapy is a type of cancer treatment that uses high-energy radiation beams to target and destroy cancer cells. It is a local treatment, meaning it affects only the specific area of the body where the cancer is located. In this trial, it is used to treat soft tissue sarcomas, which are cancers that develop in soft tissues like muscles, tendons, and fat.

What is already known about the treatment

Atezolizumab - A monoclonal antibody medication administered through intravenous infusion that belongs to the class of immune checkpoint inhibitors used in cancer immunotherapy. This medication works by binding to and blocking PD-L1 (programmed death-ligand 1) on tumor cells, which prevents them from evading immune system detection and allows T-cells to attack the cancer cells more effectively. Currently used in clinical trials for soft tissue sarcomas in combination with radiotherapy, atezolizumab represents an innovative approach in cancer treatment by enhancing the body's natural immune response against cancer cells, with established efficacy in various types of cancers and continuing investigation in new therapeutic areas.

Investigated diseases

Soft Tissue Sarcoma - A rare type of cancer that develops in soft tissues of the body, including muscles, tendons, fat, blood vessels, and nerves. The condition typically begins as a painless lump that grows over time. Localized soft tissue sarcomas are confined to one area and have not spread to other parts of the body. These tumors can develop in any part of the body but are most common in the arms, legs, and abdomen. The disease affects both adults and children, with different subtypes occurring at different ages.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-510713-15-00Protocol codeET16-132Estimated enrolment73 patientsSponsorCentre Leon Berard

sourced from the EU Clinical Trials Register and site verification

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