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Recruiting Phase 2 NCT06277154

MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment of Advanced Soft Tissue Sarcoma

Trial Parameters

Condition Leiomyosarcoma
Sponsor HRYZ Biotech Co.
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 148
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2024-02-21
Completion 2026-02
Interventions
MASCT-IDoxorubicinIfosfamide

Brief Summary

This study will evaluate the safety and efficacy of MASCT-I combined with Doxorubicin and Ifosfamide for first-line treatment in patients with advanced soft tissue sarcoma.

Eligibility Criteria

Inclusion Criteria: 1. Age≥18 years and≤70 years; 2. According to WHO Classification of Tumours, 5th Edition, Volume 3: Soft Tissue and Bone Tumours, histopathologically or cytologically confirmed unresectable locally advanced or metastatic soft tissue sarcomas, including leiomyosarcoma, liposarcoma, synovial sarcoma, angiosarcoma, undifferentiated pleomorphic sarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumors, fibrosarcoma, pleomorphic rhabdomyosarcoma, endometrial stromal sarcoma, desmoplastic small round cell tumor. 3. No previous treatment with systematic chemotherapy or targeted therapy for advanced soft tissue sarcomas or whose disease progressed after 6months of the end of neoadjuvant or adjuvant therapy. 4. At least one measurable and assessable lesion defined by RECIST 1.1; 5. ECOG performance status of 0-1; 6. Estimated life expectancy≥6 months; 7. Pulmonary function is basically normal; 8. Subjects with organ function as defined below (any blood component

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