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RECRUITING
NCT06114225
PHASE2

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

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

Summary

The aim of this study is to evaluate the efficacy and safety of pre-operative concurrent Stereotactic Body Radiotherapy (SBRT) and and programmed cell death protein-1 (PD-1) blockade immunotherapy followed by surgical metastasectomy for resectable metastatic osteosarcoma.

Official title: A Prospective Phase II Clinical Trial on Pre-operative Immunotherapy and Stereotactic Body Radiotherapy Followed by Metastasectomy in Patients With Pulmonary Resectable Recurrence of Osteosarcoma

Key Details

Gender

All

Age Range

10 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

43

Start Date

2023-06-01

Completion Date

2026-12-30

Last Updated

2023-11-02

Healthy Volunteers

No

Conditions

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 .

Locations (1)

Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine

Shanghai, Shanghai Municipality, China