Actively Recruiting
IO Combined With AI as First-line Treatment for Patients With Soft Tissue Sarcoma(TAIS)
Led by Fudan University · Updated on 2026-01-08
45
Participants Needed
1
Research Sites
252 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
IO Combined With AI as First-line Treatment for Patients With Soft Tissue Sarcoma(TAIS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years, regardless of gender
- Diagnosed with one of the specified soft tissue sarcoma subtypes confirmed by pathology
- Locally advanced disease not suitable for surgery or radiation, or recurrent/metastatic disease
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1
- Expected survival time longer than 3 months
- Laboratory tests within 7 days before screening meet specified blood counts and organ function levels
- Presence of measurable tumors according to RECIST 1.1 criteria
- Signed informed consent form indicating understanding and willingness to participate
You will not qualify if you...
- Prior treatment for advanced soft tissue sarcoma except relapse after more than 6 months from adjuvant therapy with doxorubicin cumulative dose up to 300mg/m2
- Use of experimental or anti-tumor drugs within 4 weeks before enrollment
- Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibodies, or other T-cell checkpoint inhibitors
- History of other cancers within 5 years except cured cervical cancer or basal cell carcinoma of the skin
- Symptomatic brain or meningeal metastases unless controlled and stable for over 6 months
- Clinically significant active bleeding
- Pregnant or breastfeeding women; women of childbearing potential without adequate contraception
- Alcohol or drug abuse
- Active autoimmune diseases or history of diseases with risk of recurrence, or immunosuppressive therapy requirement
- Systemic corticosteroid use equivalent to >10mg prednisone/day within 14 days before or during study
- Severe organ failure or serious diseases including heart conditions within 6 months prior to enrollment
- History of HIV infection or other immune deficiency diseases or organ/stem cell transplantation
- Active chronic hepatitis B or hepatitis C infection unless stable or cured
- Severe neurological or psychiatric disorders, severe infections, or other serious conditions endangering safety or study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
Research Team
X
Xin Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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