Pulmonary Resectable Osteosarcoma Treated by Metastasectomy and Pre-operative Immunotherapy and Stereotactic Body Radiotherapy (PROMIS): a Prospective Clinical Trial

PHASE2RecruitingINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

June 1, 2023

Primary Completion Date

September 15, 2026

Study Completion Date

December 30, 2026

Conditions
Osteosarcoma
Interventions
COMBINATION_PRODUCT

metastasectomy and pre-operative immunotherapy (gemcitabine and penpulimab ) and stereotactic body radiotherapy

participants first receive concurrent SBRT and penpulimab (PD-1 blockade) and two cycles of GP regimen (gemcitabine d1,d8 and Penpulimab d8 per a 21-day cycle), followed by complete pulmonary metastasectomy. After surgery, participant receive another 4 cycles of GP regimens followed by Penpulimab monotherapy maintenance. The rationale is that pre-operative SBRT could boost the immune microenvironment, leading to a long-term effect of immunotherapy post-metastasectomy and eventually resulting in better long-term survivorship compared to the histological control for pulmonary resectable recurrence of osteosarcoma .

Trial Locations (1)

20025

RECRUITING

Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai

All Listed Sponsors
lead

Ruijin Hospital

OTHER