Actively Recruiting
Toripalimab Combined With CAV/IE Regimen
Led by Sun Yat-sen University · Updated on 2024-01-09
200
Participants Needed
1
Research Sites
296 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of this study was to investigate the efficacy and safety of CAV/IE chemotherapy combined with toripalimab versus CAV/IE chemotherapy alone in the treatment of patients with advanced or unresectable bone and soft tissue sarcomas who failed in standard treatment.
CONDITIONS
Official Title
Toripalimab Combined With CAV/IE Regimen
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients voluntarily agree to participate and sign informed consent
- Diagnosed with advanced or unresectable bone or soft tissue sarcoma confirmed by pathology, failed standard treatment or no standard treatment exists for their subtype
- Presence of at least one measurable lesion by MRI or CT according to RECIST 1.1 within the past 3 months
- Aged between 14 and 70 years
- ECOG performance status of 0 or 1
- Expected survival time of more than 3 months
- Adequate blood counts without recent transfusion
- Liver and kidney function within specified limits
- Left ventricular ejection fraction at or above normal lower limit (50%)
- Women of childbearing age must have a negative pregnancy test and agree to use contraception during and for 6 months after the study; men must agree to use contraception during and for 6 months after the study
You will not qualify if you...
- Prior treatment with anti-PD-1 or PD-L1 antibody therapy
- Other malignancies within 5 years except certain non-invasive cancers
- Thyroid dysfunction not controlled by medication
- Planned or recent systemic anti-tumor therapy or radiotherapy within specified timeframes
- Pleural effusion or ascites causing significant breathing difficulty
- Unresolved toxic reactions from prior treatments above grade 1 (except hair loss)
- Severe or uncontrolled diseases including uncontrolled blood pressure, heart disease, infections, liver or kidney failure, uncontrolled diabetes, significant proteinuria, or epilepsy requiring treatment
- Major surgery, biopsy, or trauma within 28 days
- History or signs of bleeding or clotting events within specified timeframes
- Active ulcers, intestinal perforation, or obstruction
- Symptoms or recent treatment of central nervous system metastases except stable cases meeting criteria
- Use of immunosuppressive or systemic corticosteroid therapy above specified doses within 2 weeks
- Active autoimmune disease or history of autoimmune disease requiring intervention
- Active tuberculosis
- Any condition judged by the investigator to prevent safe participation
- Participation in other anti-tumor drug clinical trials within 28 days
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, China
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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