Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07243626

Efficacy and Safety of Envafolimab Plus Doxorubicin and Ifosfamide for Advanced Soft Tissue Sarcoma

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-04-24

25

Participants Needed

1

Research Sites

139 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Soft tissue sarcoma (STS) is a rare, highly heterogeneous malignancy with a poor prognosis. The standard first-line treatment for advanced patients is anthracyclines (doxorubicin, A) combined with ifosfamide (I, AI regimen), but the efficacy is limited, and some subtypes do not respond well. Immune checkpoint inhibitors (ICI) have shown potential in specific STS subtypes. Anthracyclines can induce immunogenic cell death and upregulate PD-L1, providing a theoretical basis for combined immunotherapy. Previous studies have shown that ICI combined with chemotherapy (such as pembrolizumab + doxorubicin) is more effective than chemotherapy alone. Envolizumab is the world's first subcutaneously injected PD-L1 single-domain antibody-Fc fusion protein, with significant advantages: (1) small molecular weight (\~80kDa) and strong tissue penetration; (2) high stability and can be stored at room temperature; (3) convenient subcutaneous injection and good tolerability (Phase II study of MSI-H/dMMR solid tumors ORR 42.7%, grade 3-4 TEAE 15.5%). In 2022, the FDA granted orphan drug designation for the treatment of STS. This study aims to evaluate the efficacy (ORR, PFS, OS, etc.) and safety of Envolizumab combined with an AI regimen (doxorubicin + ifosfamide) as a first-line treatment for advanced STS.

CONDITIONS

Official Title

Efficacy and Safety of Envafolimab Plus Doxorubicin and Ifosfamide for Advanced Soft Tissue Sarcoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pathologically confirmed advanced soft tissue sarcoma with at least one measurable lesion.
  • No previous systemic treatment for soft tissue sarcoma.
  • 18 years or older with expected survival over 3 months.
  • Adequate major organ function within 7 days before treatment including:
    • Hemoglobin 60 g/L, neutrophil count 61.5�D710^9/L, platelet count 6080�D710^9/L without blood transfusion in past 14 days.
    • Total bilirubin 61.5 times upper limit of normal; ALT and AST 62.5 times upper limit of normal (or 65 times if liver metastases).
    • Serum creatinine 61.5 times upper limit or creatinine clearance 6360 ml/min.
    • Left ventricular ejection fraction 6050%.
  • Women of childbearing potential must agree to use contraception during the study and 6 months after; negative pregnancy test within 7 days before enrollment; not breastfeeding.
  • Men must agree to use contraception during the study and 6 months after.
Not Eligible

You will not qualify if you...

  • Diagnosis of chondrosarcoma, osteosarcoma, Ewing's sarcoma, dermatofibrosarcoma protuberans, or gastrointestinal stromal sarcoma.
  • Pregnant or lactating women, or women of childbearing potential not using contraception.
  • Severe, uncontrolled acute infection or chronic infection with persistent wounds.
  • Presence of a second primary tumor (except basal cell carcinoma of the skin).
  • Participation in other drug clinical trials within 4 weeks before enrollment.
  • Severe heart disease including congestive heart failure, uncontrolled arrhythmias, unstable angina, recent myocardial infarction, severe valve disease, or refractory hypertension.
  • Uncontrolled neurological, psychiatric, or mental disorders affecting compliance.
  • Uncontrolled primary brain tumors or central nervous system metastases with significant symptoms.
  • History of hereditary bleeding disorders or coagulopathy.
  • Severe allergic or anaphylactic reactions to humanized antibodies.
  • Diagnosed immunodeficiency or use of systemic immunosuppressive therapy within 14 days prior to first dose (except low-dose glucocorticoids 6410 mg/day prednisone equivalent).
  • Active or suspected autoimmune diseases such as pneumonitis, colitis, hepatitis, hypophysitis, vasculitis, or nephritis.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Department of Medical Oncology, the Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China

Hanzhong, Zhejiang, China, 310009

Actively Recruiting

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Research Team

Y

Ying Dong

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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