Actively Recruiting
Adriamycin and Ifosfamide Combined With Sintilimab
Led by Sun Yat-sen University · Updated on 2024-01-02
176
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of this study was to explore the efficacy and safety of adriamycin and ifosfamide combined with sintilimab versus chemotherapy in the treatment of advanced or unresectable soft tissue sarcoma.
CONDITIONS
Official Title
Adriamycin and Ifosfamide Combined With Sintilimab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients voluntarily participate and sign informed consent
- Advanced or unresectable soft tissue sarcoma confirmed by pathology, including specific subtypes listed
- Failure, intolerance, or no standard treatment available
- At least one measurable target lesion by RECIST 1.1 criteria within past 3 months
- Age between 14 and 70 years
- ECOG performance score 0-1
- Expected survival time greater than 3 months
- Adequate blood counts and organ function within 7 days before treatment
- Women of childbearing age agree to use contraceptive methods during study and for 6 months after
- Negative pregnancy test within 7 days before enrollment and non-lactating
- Men agree to use contraceptive methods during study and for 6 months after
You will not qualify if you...
- Prior anti-PD-1 or PD-L1 antibody therapy
- Other malignancies within 5 years except certain skin, cervical, or bladder cancers
- Thyroid dysfunction after optimal treatment
- Recent systemic anti-tumor therapy or radiotherapy within specified timeframes
- Pleural effusion or ascites causing significant respiratory symptoms
- Unresolved toxic reactions from previous treatments above grade 1 except hair loss
- Severe or uncontrolled diseases including poor blood pressure control, heart diseases, infections, liver or kidney failure, diabetes, epilepsy
- Major surgery, biopsy, or trauma within 28 days before enrollment
- History or signs of bleeding disorders or recent serious bleeding events
- Recent arterial or venous thrombotic events within 6 months
- Active ulcers, intestinal perforation, or obstruction
- Active central nervous system metastasis or recent treatment for brain metastases unless stable
- Use of immunosuppressive or systemic hormone therapy within 2 weeks before enrollment
- Active autoimmune diseases or history of such conditions
- Active tuberculosis
- Other serious diseases, mental illness, or social/family factors affecting safety or data collection
- Participation in other anti-tumor drug trials within 28 days before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Xing Zhang
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
X
Xing Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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