Phase II Study of PARP Inhibitor and PD-1 Immunotherapy with Stereotactic Body Radiotherapy for Advanced or Metastatic Bone and Soft Tissue Sarcoma

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.

PARP Inhibition, Stereotactic Body Radiotherapy and Immunotherapy for Metastatic or Advanced Sarcoma (PRIMA)