Actively Recruiting
PARP Inhibition, Stereotactic Body Radiotherapy and Immunotherapy for Metastatic or Advanced Sarcoma (PRIMA)
Led by Ruijin Hospital · Updated on 2023-10-31
86
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 PARP Inhibition and programmed cell death protein-1 (PD-1) blockade immunotherapy with concurrent stereotactic body radiotherapy (SBRT) for metastatic or advanced bone and soft tissue sarcoma.
CONDITIONS
Official Title
PARP Inhibition, Stereotactic Body Radiotherapy and Immunotherapy for Metastatic or Advanced Sarcoma (PRIMA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent before any trial procedures
- Histologically confirmed high-grade bone or soft tissue sarcoma with distant metastasis or locally advanced disease that cannot be completely removed or patient refuses surgery
- Have received at least one prior systemic treatment but no previous PARP inhibitor treatment
- Measurable lesions according to RECIST 1.1
- Age between 10 and 70 years
- ECOG performance status 0 to 2 for patients 16 years or older; Lansky score at least 70 for patients under 16
- Expected survival time greater than 24 weeks
- Majority of recurrent lesions suitable for stereotactic body radiotherapy (SBRT)
- Major organ functions meet safety standards within 7 to 14 days before treatment
- Women of childbearing potential must agree to use contraception during and for 6 months after the study; negative pregnancy test within 7 days before enrollment; males must agree to use contraception during and for 6 months after the study
- For recurrent lesions previously treated by surgery, radiofrequency ablation, or radiotherapy, stable lesions or those suitable for SBRT are allowed
You will not qualify if you...
- Diagnosis of malignant diseases other than tumors within 5 years before first dose
- Participation in other interventional clinical trials or use of investigational drugs or devices within 4 weeks before first dose
- Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or other T cell receptor targeting drugs with secondary resistance
- Use of systemic anti-tumor Chinese patent medicines or immunomodulatory drugs within 2 weeks before first dose
- Active autoimmune disease requiring systemic treatment within 2 years before first dose
- Use of systemic glucocorticoids or immunosuppressives within 7 days before first dose
- Known allogeneic organ transplantation except corneal
- Allergy to components of monoclonal antibody preparations with severe reactions
- Incomplete recovery from toxicity or complications from prior interventions
- Known HIV infection
- Live vaccine within 30 days before first dose
- Pregnant or lactating women
- Any serious or uncontrollable systemic disease
AI-Screening
AI-Powered Screening
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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
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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