RecruitingPhase 2NCT06849986

IO Combined With AI as First-line Treatment for Patients With Soft Tissue Sarcoma(TAIS)

Tislelizumab Combined With Liposomal Doxorubicin and Ifosfamide as First-line Treatment for Patients With Specified Subtypes of Unresectable or Metastatic Soft Tissue Sarcoma: a Multi-center, Single-arm, Prospective Phase II Clinical Trial


Sponsor

Fudan University

Enrollment

45 participants

Start Date

Feb 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study will enroll patients with specific subtypes of unresectable or metastatic soft tissue sarcoma, and will combine tislelizumab with the standard chemotherapy of liposomal doxorubicin and ifosfamide to initially explore the efficacy and safety.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining immunotherapy with an anti-angiogenic drug (a medication that cuts off blood supply to tumors) as first-line treatment improves survival in patients with advanced or metastatic soft tissue sarcoma (a cancer of connective tissues such as fat, muscle, or nerves). **You may be eligible if...** - You are between 18 and 75 years old - Your soft tissue sarcoma has been confirmed by biopsy and is one of the eligible subtypes: undifferentiated sarcoma, synovial sarcoma, angiosarcoma, fibrosarcoma, smooth muscle sarcoma, liposarcoma (non-well-differentiated), pleomorphic rhabdomyosarcoma, or malignant peripheral nerve sheath tumor - Your disease is locally advanced or metastatic - You have not received prior systemic treatment for advanced disease **You may NOT be eligible if...** - Your sarcoma subtype is not on the eligible list (e.g., Ewing sarcoma, well-differentiated liposarcoma) - You have had prior chemotherapy or targeted therapy for metastatic disease - You have serious heart disease or uncontrolled high blood pressure - You are pregnant or breastfeeding 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

DRUGTislelizumab+liposomal doxorubicin+ifosfamide

Liposomal Doxorubicin (PLD) 30mg/m2 on day 1 Ifosfamide (IFO) 3 g/m2/day on days 1 to 3 Tislelizumab 200mg on day 1, administered by intravenous infusion, every 3 weeks


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06849986


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