Actively Recruiting
Pulmonary Resectable Osteosarcoma Treated by Metastasectomy and Pre-operative Immunotherapy and Stereotactic Body Radiotherapy (PROMIS): a Prospective Clinical Trial
Led by Ruijin Hospital · Updated on 2023-11-02
43
Participants Needed
1
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of this study is to evaluate the efficacy and safety of pre-operative concurrent Stereotactic Body Radiotherapy (SBRT) and and programmed cell death protein-1 (PD-1) blockade immunotherapy followed by surgical metastasectomy for resectable metastatic osteosarcoma.
CONDITIONS
Official Title
Pulmonary Resectable Osteosarcoma Treated by Metastasectomy and Pre-operative Immunotherapy and Stereotactic Body Radiotherapy (PROMIS): a Prospective Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before starting any trial procedures
- Histologically confirmed osteosarcoma with lung metastases but no local recurrence (prior local re-resection with clear margins allowed)
- Lung nodules removable by wedge resection, segmentectomy, or lobectomy without total pneumonectomy and no malignant pleural effusion
- At least one prior standardized systemic treatment regimen received, but no previous gemcitabine
- Adequate lung function for one- or two-stage thoracic surgery
- Age between 10 and 65 years
- ECOG score 0 to 2 for patients 16 years or older; Lansky score at least 70 for those under 16
- Expected survival time longer than 24 weeks
- Most recurrent lesions suitable for SBRT
- Major organ functions meet safety standards within 7-14 days before treatment
- Women of childbearing age agree to use contraception during and for 6 months after the study; negative pregnancy test and non-lactating
- If recurrent lesions were previously treated, stable lesions do not require SBRT; progressive lesions may be eligible if SBRT is possible
You will not qualify if you...
- Diagnosed with malignant diseases other than tumors within 5 years before first dose
- Currently in other interventional clinical trials or used investigational drugs/devices within 4 weeks
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or other T cell receptor targeting drugs with secondary resistance
- Received systemic Chinese patent medicines with anti-tumor or immunomodulatory effects within 2 weeks before first dose
- Active autoimmune disease needing systemic treatment within 2 years
- Receiving systemic glucocorticoids or immunosuppressive therapy within 7 days before first dose
- History of allogeneic organ or stem cell transplant (except corneal)
- Known allergy to monoclonal antibody components (severe reactions)
- Not fully recovered from prior treatment toxicities except mild fatigue or alopecia
- Known HIV infection
- Received live vaccine within 30 days before first dose
- Pregnant or breastfeeding women
- Any serious or uncontrolled systemic disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai, Shanghai Municipality, China, 20025
Actively Recruiting
Research Team
W
Weibin Zhang, PhD, MD
CONTACT
Y
Yuhui Shen, PhD, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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