Abscopal effects under radio-immunotherapy of all tumour entities treated with it
Conditions
Interventions
Group 1: Radiotherapy and Immune Checkpoint Inhibition
Sponsors
Universitätsklinikum Köln
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Patients with documented evidence of metastatic solid tumor of any entity and simultaneous RT-ICI between 06/2015 (start ICI) and 06/2021 (end RT) at participating centers. - At least one lesion outside the irradiation field: non-irradiated lesion (outside the 10% isodose, NIL) - Radiological images of the NILs prior to initiation of RT (at least two) and after the end of RT (at least one) to exclude an effect induced by ICI only
Exclusion criteria
Exclusion criteria: - Start of another systemic therapy during the time period being analyzed - Inadequate imaging to assess abscopal effect or exclude response induced by ICI only
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of abscopal effects based on radiological images of non-irradiated lesions: long axis diameter (nodal lesions: short axis diameter) (mm) measurement in =3 radiological images according to iRECIST: - AR = Abscopal Response: Reduction by =30% - AP = Abscopal Progression: Increase by =20% - AC = Abscopal Control | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints: - Survival outcomes (OS, PFS) - RT-ICI concepts used (dose, fractionation, technique, sequence) - Number of applied RT-courses ("lifetime” RT dose) - Change in laboratory parameters if available (inflammation status, nutrition status, LDH, HPV, EBV, PDL1) | — |
Countries
Germany
Contacts
Public ContactMaike Trommer
Universitätsklinikum Köln
Outcome results
None listed