Actively Recruiting
MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment of Advanced Soft Tissue Sarcoma
Led by HRYZ Biotech Co. · Updated on 2025-07-24
148
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
Sponsors
H
HRYZ Biotech Co.
Lead Sponsor
S
Sun Yat-Sen University Cancer Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment of Advanced Soft Tissue Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years
- Histopathological or cytological confirmation of unresectable locally advanced or metastatic soft tissue sarcoma as defined by WHO Classification, including specified sarcoma types
- No prior systemic chemotherapy or targeted therapy for advanced soft tissue sarcoma, or progression after at least 6 months from prior neoadjuvant or adjuvant therapy
- At least one measurable and assessable lesion according to RECIST 1.1
- ECOG performance status of 0 or 1
- Estimated life expectancy of 6 months or more
- Normal pulmonary function
- Adequate organ function with specified blood counts and liver/kidney function parameters
- Written informed consent obtained
- Agreement to use effective contraception during and for 6 months after treatment, with negative HCG test for females with potential fertility
You will not qualify if you...
- Previous targeted therapy, radiotherapy (except certain cases), or antineoplastic drugs within 4 weeks before randomization
- Diagnosis of sarcoma types unsuitable for Doxorubicin and Ifosfamide treatment
- Prior anthracycline treatment exceeding cumulative dose equivalent to 200 mg/m2 Doxorubicin
- Previous MASCT, cellular immunotherapy, or anti-PD-1/PD-L1 antibody therapy within the past year
- Use of immunosuppressive agents or systemic steroids above specified doses within 2 weeks before randomization
- Allergies to sodium citrate or human albumin
- Uncontrolled pleural, abdominal, or pericardial effusions
- Active central nervous system or meningeal metastases, except stable treated brain metastases
- Active or history of autoimmune diseases
- Active tuberculosis or infections with hepatitis B, C, HIV, or syphilis
- Severe cardiovascular disease or recent thrombotic/cerebrovascular events
- Other malignancies within 5 years, except certain cured cancers
- History or planned organ transplantation
- Major surgery or trauma within 4 weeks before randomization
- History of substance abuse or severe mental disorders
- Planned surgery for soft tissue sarcoma during the study
- Participation in another investigational trial within 4 weeks before randomization
- Any condition that the investigator considers may harm the participant or prevent study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, China
Actively Recruiting
Research Team
W
Wenjin Huang
CONTACT
X
Xuemin Rao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here