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

Sponsor
Ruijin Hospital
Study ID
NCT06074692
Phase
PHASE2
Status
Recruiting
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Conditions

  • Sarcoma
  • Sarcoma of Bone
  • Sarcoma,Soft Tissue

Eligibility Criteria

Sex
ALL
Age
10 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jun 1, 2023
Status verified
Oct 2023
Primary completion
Aug 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
86 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bone arm
    Bone tumor subgroup (bone arm) includes high-grade osteosarcoma, chondrosarcoma, undifferentiated bone sarcoma and other rare bone sarcomas with complex genomic features..
  • Experimental: Soft tissue arm
    Soft tissue sarcoma subgroup (soft tissue arm) includes leiomyosarcoma, pleomorphic rhabdomyosarcoma, angiosarcoma, fibrosarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumor(MPNST) and other rare soft tissue sarcomas with complex genomic features.
  • Experimental: UPS/DDLPS arm
    Immune hot tumor subgroup (UPS/DDLPS arm) includes undifferentiated pleomorphic sarcoma (UPS), dedifferentiated liposarcoma (DDLPS).

Primary Outcome Measure

6-momth progression-free survival rate (6m-PFSR) [ Time Frame: 6 months from recruitment ]

Central Contacts

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