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

Sponsor
Ruijin Hospital
Study ID
NCT06114225
Phase
PHASE2
Status
Recruiting
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Conditions

  • Osteosarcoma

Eligibility Criteria

Sex
ALL
Age
10 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • metastasectomy and pre-operative immunotherapy (gemcitabine and penpulimab ) and stereotactic body radiotherapy — COMBINATION_PRODUCT
    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 .

Study Details

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.

Key Dates

First listed
Nov 2, 2023
Start date
Jun 1, 2023
Status verified
Oct 2023
Primary completion
Sep 15, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
43 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: treatment arm
    The participant receive metastasectomy, immunotherapy and Stereotactic Body Radiotherapy (SBRT)

Primary Outcome Measure

12-month progression-free survival rate (12m-PFSR) [ Time Frame: 12 months from recruitment ]

Central Contacts

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