Actively Recruiting
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
Led by HRYZ Biotech Co. · Updated on 2025-07-24
148
Participants Needed
1
Research Sites
52 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
Researchers are evaluating the safety and efficacy of MASCT-I combined with Doxorubicin and Ifosfamide as a first treatment option for patients with advanced soft tissue sarcoma who have metastatic or recurrent unresectable disease. This randomized, open-label Phase II study focuses on several types of soft tissue sarcoma, including leiomyosarcoma, liposarcoma, synovial sarcoma, and others, aiming to understand how well this combination works and its safety profile. The study includes two treatment groups: one receiving MASCT-I together with Doxorubicin and Ifosfamide, and the other receiving only Doxorubicin and Ifosfamide. MASCT-I involves injections of dendritic cells given under the skin and effector T cells given intravenously. Doxorubicin and Ifosfamide are administered according to the treatment protocol. Participants receive these treatments as their first-line therapy for advanced disease. Participants will be closely monitored through various assessments over three years, including measuring progression-free survival as the main outcome. Other outcomes include overall survival, response rates, disease control, duration of response, and safety through adverse event monitoring and laboratory tests. The study involves regular evaluations to track treatment effects and side effects, with participant involvement lasting up to three years.
CONDITIONS
Brief 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
- Histopathologically or cytologically confirmed unresectable locally advanced or metastatic soft tissue sarcomas as defined by WHO Classification
- No prior systemic chemotherapy or targeted therapy for advanced soft tissue sarcomas or disease progression after 6 months of neoadjuvant/adjuvant therapy
- At least one measurable lesion defined by RECIST 1.1
- ECOG performance status of 0-1
- Estimated life expectancy of 6 months or more
- Pulmonary function basically normal
- Adequate organ function as defined by specific blood and biochemical parameters
- Written informed consent obtained
- Use of effective contraception during and 6 months after treatment; negative HCG test for females with potential fertility
You will not qualify if you...
- Previous targeted therapy, radiotherapy (except certain cases), or other antineoplastic drugs within 4 weeks before randomization
- Certain sarcoma subtypes not suitable for Doxorubicin and Ifosfamide treatment
- Prior anthracycline treatment exceeding cumulative dose equivalent to 200mg/m2 doxorubicin
- Previous MASCT or other cellular immunotherapy or anti-PD-1/PD-L1 therapy within 1 year
- Use of immunosuppressive agents or hormones exceeding 10mg prednisone within 2 weeks before randomization
- Allergy to sodium citrate or human albumin
- Uncontrolled pleural or abdominal effusion requiring repeated drainage or significant pericardial effusion
- Active central nervous system or meningeal metastases unless stable
- Active autoimmune disease or history of autoimmune disease
- Active tuberculosis
- Infection with hepatitis B, hepatitis C, HIV, or syphilis
- Severe cardiovascular diseases or conditions affecting study participation
- History of thrombus or cerebrovascular accident within 6 months
- Other recent malignancies except certain in situ cancers
- Organ transplantation history or planned transplantation
- Major surgery or traumatic injury within 4 weeks
- History of alcohol dependence, psychotropic substance abuse, or mental disorders
- Planned surgery for soft tissue sarcoma during the study
- Participation in another investigational trial within 4 weeks
- Any condition judged by investigator to interfere with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 3 years
Participants receive MASCT-I combined with Doxorubicin and Ifosfamide or Doxorubicin and Ifosfamide alone as first-line treatment for advanced soft tissue sarcoma.
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, China
Actively Recruiting
Research Team
W
Wenjin Huang
X
Xuemin Rao
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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