RecruitingPhase 2NCT06277154

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


Sponsor

HRYZ Biotech Co.

Enrollment

148 participants

Start Date

Feb 21, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of an immune-boosting therapy (MASCT-I) with standard chemotherapy (doxorubicin and ifosfamide) as a first-line treatment for people with advanced soft tissue sarcoma — a cancer arising from tissues like muscle, fat, blood vessels, and nerves. **You may be eligible if...** - You are between 18 and 70 years old - You have confirmed advanced (unresectable or metastatic) soft tissue sarcoma of specific subtypes (e.g., leiomyosarcoma, liposarcoma, synovial sarcoma, and others) - You have not previously received systemic chemotherapy for advanced disease - You have measurable tumor(s), adequate physical function (ECOG 0-1), and expected survival over 6 months - Your blood counts and organ function are within acceptable limits **You may NOT be eligible if...** - Your sarcoma subtype is not eligible for the study - You have received prior chemotherapy or targeted therapy for advanced disease (unless your disease relapsed more than 6 months after completing adjuvant therapy) - Your blood counts or organ function do not meet the required thresholds 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

BIOLOGICALMASCT-I

The final products of MASCT-I technology are dendritic cells (DC) and effector T cells.

DRUGDoxorubicin

Commercially approved for cancer treatment

DRUGIfosfamide

Commercially approved for cancer treatment


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, China

View Full Details on ClinicalTrials.gov

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NCT06277154


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