Actively Recruiting
A Prospective Phase II Study of PARP Inhibition and Check Point-inhibition Immunotherapy With Concurrent Stereotactic Body Radiotherapy in Patients With Metastatic or Advanced Sarcoma
Led by Ruijin Hospital · Updated on 2023-10-31
86
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness and safety of combining PARP inhibitors and PD-1 blockade immunotherapy with stereotactic body radiotherapy (SBRT) in treating metastatic or advanced bone and soft tissue sarcoma. These sarcomas are diverse, aggressive tumors with poor survival rates using traditional treatments, and this trial explores a novel personalized approach based on molecular characteristics and tumor genetics. The study also investigates biomarkers like tumor gene mutations and homologous recombination deficiency to support precise treatment. Participants receive a combination treatment of Camrelizumab (a PD-1 inhibitor) and Fluzoparib (a PARP inhibitor) together with SBRT. The trial includes three subgroups based on sarcoma type: bone sarcomas, soft tissue sarcomas, and immune hot tumors such as undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma. This phase II study monitors the concurrent administration of these therapies to assess their combined impact on the disease. Throughout the study, participants undergo assessments including tumor measurements by RECIST 1.1 criteria and safety evaluations. Key outcomes measured include progression-free survival at six months, response rates, disease control, duration of response, overall survival, quality of life, and adverse events, with follow-up lasting up to three years. The trial also evaluates biomarkers for a deeper understanding of treatment effects and patient response.
CONDITIONS
Brief 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 not fully resectable or unsuitable for surgery
- Received at least one prior systemic treatment regimen but no previous PARP inhibitor therapy
- Presence of measurable lesions per RECIST 1.1 criteria
- Age between 10 and 70 years old
- For patients 16 years or older, ECOG performance status 0 to 2 or ability to care for self and move with assistance
- For patients under 16 years old, Lansky score of 70 or above or ability to participate in most recreational activities with assistance
- Expected survival greater than 24 weeks
- Recurrent lesions suitable for stereotactic body radiotherapy
- Adequate major organ function within 7 to 14 days before treatment
- Women of childbearing potential must use contraception during and for 6 months after study; men must also use contraception
- If recurrent lesions were previously treated, stable or suitable for repeat SBRT as specified
You will not qualify if you...
- Diagnosis of other malignant diseases within 5 years before first dose
- Participation in other interventional clinical trials or use of investigational drugs/devices within 4 weeks before first dose
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or T cell receptor-targeting drugs with secondary resistance
- Use of systemic 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 immunosuppressants within 7 days before first dose
- History of allogeneic organ or hematopoietic stem cell transplantation
- Allergy to monoclonal antibody components with severe reactions
- Unresolved toxicity or complications from prior treatments above grade 1
- Known HIV infection
- Live vaccine within 30 days before first dose
- Pregnant or breastfeeding women
- Serious or uncontrolled systemic diseases
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From baseline until disease progression or discontinuation, up to 3 years
Participants receive Camrelizumab (PD-1 inhibitor) and fluzoparib (PARP inhibitor) with concurrent stereotactic body radiotherapy (SBRT) for metastatic or advanced bone and soft tissue sarcoma.
Visits occur regularly during treatment as per protocol
Duration - Up to 3 years after treatment ends
Participants are monitored for safety and efficacy after completion of treatment, including assessments of survival and quality of life.
Periodic visits for follow-up assessments
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
Y
Yuhui Shen, PhD, MD
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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