RT-IMMUNE - A European, multicenter, randomized, open-label, Phase II trial, aiming to assess the clinical and biological activity of an anti-PD-L1 (atezolizumab) in operable localised soft tissue sarcomas patients to be treated with radiotherapy

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-510713-15-00

Acronym

ET16-132

Enrollment

Registered

2024-10-28

Start date

2018-07-30

Completion date

Unknown

Last updated

2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Localised and operable soft tissue sarcomas

Brief summary

Rate of pathological response defined by at least ≥80% pathologic necrosis on the surgery specimen.

Detailed description

- Rate of patients with complete or near-complete pathologic response defined as ≥ 95% tumor necrosis. - Rate of patients with at least ≥ 50% tumor necrosis . - Percentage of residual viable cells. - Objective Response Rate as RECIST v1.1. - Tumor volume change - Quality of resection and amputation rate. - Local Recurrence Rate (LRR) at 1 year post-surgery - Time To Relapse (TTR) - Disease Free Survival (DFS), Evolution of number of T cells (including but not limited to GmzB+/CD8+ T-cell, CD3+), B cells (CD20, IgG), and Treg (FOXP3) on pre (de novo tumor biopsy at baseline) and post-treatment (surgery specimen) by immunofluorescence., Incidene of Adverse Event (AE), Serious Adverse Events (SAEs), AESI and SUSARs.

Interventions

DRUGTecentriq 1 200 mg concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Rate of pathological response defined by at least ≥80% pathologic necrosis on the surgery specimen.	—

Secondary

Measure	Time frame
- Rate of patients with complete or near-complete pathologic response defined as ≥ 95% tumor necrosis. - Rate of patients with at least ≥ 50% tumor necrosis . - Percentage of residual viable cells. - Objective Response Rate as RECIST v1.1. - Tumor volume change - Quality of resection and amputation rate. - Local Recurrence Rate (LRR) at 1 year post-surgery - Time To Relapse (TTR) - Disease Free Survival (DFS), Evolution of number of T cells (including but not limited to GmzB+/CD8+ T-cell, CD3+), B cells (CD20, IgG), and Treg (FOXP3) on pre (de novo tumor biopsy at baseline) and post-treatment (surgery specimen) by immunofluorescence., Incidene of Adverse Event (AE), Serious Adverse Events (SAEs), AESI and SUSARs.	—

Measure

Time frame

—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026