NCT06849986

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Soft tissue sarcoma is a type of malignant tumor originating from the mesenchymal tissue of soft tissues and visceral organs, and can occur in various parts of the human body. The incidence of soft tissue sarcoma accounts for about 1% of all adult malignant tumors and 15% of pediatric malignant tumors. Surgical resection is the cornerstone of soft tissue sarcoma treatment, but since soft tissue sarcomas often metastasize systemically, even early-stage cases can see lung metastasis. Except for solitary lung metastases, which still advocate surgical resection, the rest all require drug treatment, especially for the treatment of locally advanced or metastatic soft tissue sarcoma, systemic chemotherapy is the main means of clinical application. Once soft tissue sarcoma metastasizes to a distant site, the prognosis is extremely poor, with a median survival time of less than 1 year. Clinical research results show that doxorubicin (ADM) is the basic and standard drug for the treatment of soft tissue sarcoma, and the combination of ADM and ifosfamide (IFO) (AI regimen) can increase the effective rate to 35%. The AI regimen is a commonly used first-line combination treatment for advanced soft tissue sarcoma. Immune checkpoints have been approved by the FDA for the clinical treatment of various types of tumors. 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

• Soft Tissue Sarcomas
• Angiosarcoma
• Fibrosarcoma
• Leiomyosarcoma
• Pleomorphic Liposarcoma
• Malignant Peripheral Nerve Sheath Tumor (MPNST)
• Desmoplastic Small Round Cell Tumor

Interventions

Type	Name	Description
DRUG	Tislelizumab+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

Timeline

• Start date: 2025-02-25
• Primary completion: 2027-12-31
• Completion: 2029-12-31
• First posted: 2025-02-27
• Last updated: 2026-01-08

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study