PARP Inhibition, Stereotactic Body Radiotherapy and Immunotherapy for Metastatic or Advanced Sarcoma (PRIMA)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age10-70
SponsorRuijin Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Written informed consent signed before any trial-related procedures are carried out
Histologically confirmed high-grade sarcoma of bone or soft tissue; the lesion has distant metastasis or is locally advanced and cannot be completely resected at the time of enrollment, or the patient cannot tolerate or refuses surgical resection;
Have received at least one systemic treatment regimen(s) at the time of enrollment, and have not received prior PARP inhibitor treatment.
With measurable lesions according to Response Evaluation Criteria in Solid Tumors (RECIST1.1);
Disqualifiers
Diagnosed with malignant diseases other than tumors within 5 years before the first dose;
Currently participating in interventional clinical research treatment, or have received other research drugs or used research equipment within 4 weeks before the first dose;
Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs targeting another stimulating or synergistic inhibition of T cell receptors (e.g., CTLA-4, OX-40, CD137) drug and secondary resistance to the drug (i.e., the best efficacy evaluation is CR, PR or SD lasting more than 4 months, but secondary tumor resistance develops after treatment).
Received systemic systemic treatment with Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except local use to control pleural effusion) within 2 weeks before the first dose;
Trial design
Treatments tested in this trial
- Camrelizumab and fluzoparib with concurrent stereotactic body radiotherapy (SBRT)
Treatment groups
86 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov