NCT06277154

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

A Phase II Study Evaluating the Safety and Efficacy of MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment in Patients With Advanced Soft Tissue Sarcoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 148 (estimated)
• Sponsor: HRYZ Biotech Co. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multicenter, randomized, open-label study to evaluate the safety and efficacy of MASCT-I combined with Doxorubicin and Ifosfamide for first-line treatment in patients with metastatic or recurrent unresectable advanced soft tissue sarcoma.

Conditions

• 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

Interventions

Type	Name	Description
BIOLOGICAL	MASCT-I	The final products of MASCT-I technology are dendritic cells (DC) and effector T cells.
DRUG	Doxorubicin	Commercially approved for cancer treatment
DRUG	Ifosfamide	Commercially approved for cancer treatment

Timeline

• Start date: 2024-02-21
• Primary completion: 2026-02-01
• Completion: 2027-02-01
• First posted: 2024-02-26
• Last updated: 2025-07-24

Locations

1 site across 1 country: China