RecruitingPhase 2NCT06074692

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

A Prospective Phase II Study of PARP Inhibition and Check Point-inhibition Immunotherapy With Concurrent Stereotactic Body Radiotherapy (SBRT) in Patients With Metastatic or Advanced Sarcoma


Sponsor

Ruijin Hospital

Enrollment

86 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 10 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study (called PRIMA) is testing a combination of three treatments — a PARP inhibitor (a targeted drug that attacks cancer DNA repair), stereotactic body radiation therapy (precise, high-dose radiation), and immunotherapy — for people with advanced or metastatic high-grade sarcoma, a rare type of cancer affecting bones or soft tissues. **You may be eligible if...** - You have been diagnosed with high-grade sarcoma of the bone or soft tissue - Your cancer has spread to distant sites (metastatic) or is locally advanced and cannot be fully removed by surgery - You are able to give written informed consent - You meet other medical criteria confirmed by the study team **You may NOT be eligible if...** - Your sarcoma is low-grade - You have not been histologically confirmed (diagnosed through tissue biopsy) - You are unable to participate due to other medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTCamrelizumab and fluzoparib with concurrent stereotactic body radiotherapy (SBRT)

Patients receive Camrelizumab (PD-1 inhibitor) and fluzoparib (PARP inhibitor) with concurrent stereotactic body radiotherapy (SBRT)


Locations(1)

Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine

Shanghai, Shanghai Municipality, China

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NCT06074692


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