RecruitingPhase 2NCT07049848

SATURN-STS: Phase II Study of Neoadjuvant Atezolizumab With Doxorubicin, Concurrent Atezolizumab With Pre-operative Radiation Therapy and Adjuvant Atezolizumab in Patients With High-risk Surgically Resectable Extremity and Truncal Soft Tissue Sarcoma


Sponsor

M.D. Anderson Cancer Center

Enrollment

50 participants

Start Date

Sep 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical research study is to look at the effectiveness of giving a combination of chemotherapy, immunotherapy, radiation therapy, and surgery to treat soft tissue sarcomas that can be removed by surgery. Researchers want to find out if this treatment combination can extend the time it takes for the disease to relapse (come back after treatment). The safety of this treatment combination will also be studied.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase II trial tests a treatment approach for people with a type of soft tissue cancer (sarcoma) in the arm, leg, or trunk that can be surgically removed. The study combines an immunotherapy drug called atezolizumab with chemotherapy (doxorubicin) before surgery and with radiation therapy, then continues atezolizumab after surgery. **You may be eligible if:** - You are 18 or older and have a newly diagnosed or locally returned sarcoma in your arm, leg, or outer trunk - Your tumor is grade 2 or 3 and is one of several specific sarcoma types (e.g., undifferentiated pleomorphic sarcoma, myxofibrosarcoma, liposarcoma, or leiomyosarcoma) - Your tumor is larger than 5 cm and is considered surgically removable by a multidisciplinary team - You have not had prior chemotherapy or radiation for this sarcoma - You have adequate blood counts, kidney, liver, and heart function **You may NOT be eligible if:** - Your cancer has spread to other parts of the body (metastatic) - You have previously received immunotherapy (e.g., anti-PD-1 or anti-CTLA-4 drugs) - You have an active autoimmune disease - You have serious heart or lung conditions - You are pregnant or breastfeeding - You weigh more than 400 lbs (due to radiation table weight limits) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAtezolizumab

Given by IV

DRUGDoxorubicin Hydrochloride

Given by IV


Locations(1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

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NCT07049848


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