Phase II Study of Atezolizumab with Chemotherapy and Radiation Before Surgery for High-Risk Soft Tissue Sarcoma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT07049848

Provider View

This study is testing a combination of treatments, including chemotherapy, immunotherapy, radiation, and surgery, to see if they can help control soft tissue sarcomas that can be surgically removed. Researchers want to know if this approach can delay the cancer from coming back and if it is safe for patients.

Patient Parameters

Program Overview

The purpose of this study is to evaluate if a combination of treatments—chemotherapy with doxorubicin, immunotherapy with atezolizumab, radiation therapy, and surgery—can effectively treat high-risk soft tissue sarcomas that can be surgically removed. The study aims to find out if this treatment can delay the cancer from returning and assess its safety.

Description

This study involves several steps to treat high-risk soft tissue sarcomas:

  1. Chemotherapy and Immunotherapy: Patients will first receive chemotherapy with doxorubicin and immunotherapy with atezolizumab to shrink the tumor before surgery.

  2. Radiation Therapy: Before surgery, patients will also receive radiation therapy along with atezolizumab to further reduce the tumor size.

  3. Surgery: After these treatments, patients will undergo surgery to remove the tumor.

  4. Post-Surgery Immunotherapy: After surgery, patients will continue to receive atezolizumab to help prevent the cancer from coming back.

The study will monitor how long it takes for the cancer to return, the response of the tumor to the treatment, and the safety of the treatment combination. Researchers will also look at how the tumor and the immune system interact during treatment.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older with newly diagnosed or locally recurring soft tissue sarcomas in the limbs or superficial trunk.
  • Must have a specific type of sarcoma, such as undifferentiated pleomorphic sarcoma, myxofibrosarcoma, or leiomyosarcoma.
  • Must have a tumor that can be measured and is at least 5 cm in size.
  • Tumor must be removable by surgery without involving major blood vessels, nerves, or bones.
  • Must have a life expectancy of more than 6 months.
  • Must be in good general health with an ECOG performance status of 0 to 2.
  • Must have stable blood and organ function.
  • Must agree to use effective birth control during the study and for a period after the study.
  • Must be willing to sign an informed consent form.

Exclusion Criteria

  • Tumors that cannot be safely removed by surgery.
  • Previous chemotherapy or radiation for the current sarcoma.
  • Cancer that has spread to other parts of the body or lymph nodes.
  • Active second cancer within the last 2 years.
  • History of lung diseases like pulmonary fibrosis or pneumonitis.
  • Currently receiving other cancer treatments or investigational drugs.
  • Recent stroke or blood clot requiring treatment.
  • Serious medical conditions that could increase risks during the study.
  • Active autoimmune diseases or infections like hepatitis or tuberculosis.
  • Pregnant or breastfeeding women.
  • Patients weighing over 400 lbs due to equipment limitations.
  • Recent major surgery or planned major surgery during the study.

Locations

FACILITYZIPCITYSTATE
The University of Texas M. D. Anderson Cancer Center77030HoustonTexas

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