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

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT07243626
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Soft Tissue Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Envafolimab combined with an AI regimen (doxorubicin and ifosfamide) — DRUG
    Envafolimab combined with an AI regimen: liposomal doxorubicin 35 mg/m² on day 1; IFO 2.5 mg/m² on days 1-3, intravenous infusion, every 3 weeks.

Study Details

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.

Key Dates

First listed
Nov 24, 2025
Start date
Sep 30, 2024
Status verified
Sep 2025
Primary completion
Dec 30, 2026
Completion
Jun 1, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: intervention
    Eligible patients with soft tissue sarcoma were enrolled and treated with Envafolimab 300 mg/dose subcutaneously every 3 weeks on day 1. The AI regimen consisted of liposomal doxorubicin 35 mg/m² on day 1 and intravenous infusion of IFO 2.5 mg/m² on days 1-3, every 3 weeks. Efficacy and safety were assessed approximately every 6 weeks (42 ± 7 days). Patients with disease control (CR+PR+SD) and tolerable adverse reactions could choose continue treatment until disease progression, unacceptable toxicity, or discontinuation at the investigator's discretion.

Primary Outcome Measure

Efficcy-Progression-free survival [ Time Frame: From enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months ]

Central Contacts

Related Studies