Immunotherapy for the treatment of several cancer entities steadily increased during the last years. The data from the finalized and ongoing studies show the tremendous impact of immune checkpoint inhibition (ICI) also for advanced metastatic patients. Especially the ICI with pembrolizumab and nivolumab have an increasing number of first line treatment approvals. However, in particular metastatic patients which receive ICI therapy are often irradiated for immediate palliation of several metastases. Preclinical work revealed that radiotherapy (RT) is capable to modulate the tumor phenotype, its microenvironment in a way that systemic anti-tumor immune responses are induced. However, radiation has also immune suppressive properties as e.g. the expression of immune checkpoint molecules is increased following radiotherapy. So the ICI therapy in combination with the RT has the potential to overcome the immunotolerance of the tumor and the metastases. More and more reports therefore describe a so-called systemic immune-modulating effect of radiotherapy (former and still often named as abscopal effect). However the timely application of ICI and RT is often randomly and depends on the clinical need for the palliative RT. The aim of this trial is therefore to standardize the chronology of RT in combination with ICI, to evaluate the effects of radio-immunotherapy with a stratified and comparable patient cohort. The ST-ICI study is a prospective and observational study not influencing the standard therapeutic scheme and will provide hints how the radio-immune therapy drives systemic anti tumor responses.
Study Type
OBSERVATIONAL
Enrollment
150
The normal clinical treatment-plan of the underlying disease remains unchanged.
The normal clinical treatment-plan of the underlying disease remains unchanged.
The normal clinical treatment-plan of the underlying disease remains unchanged.
The normal clinical treatment-plan of the underlying disease remains unchanged.
Department of Radiation Oncology, Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany
Systemic (according to iRECIST criteria) and local response of detected metastases during radio and/or immunotherapy.
Time frame: From date of inclusion to the trial until the date of first documented iRECIST progression or date of death from any cause, whichever came first, assessed up to day 540.
Change of circulating immune cells of treated patients by deep immunophenotyping.
Immunophenotyping of the patients: Detection of about 30 distinct immune sell (sub)types together with their activation markers. The analyses are conducted at time points before (day 0) and before every prescription of ICI (every 14 to 21 days) till progression or end of study at day 540.
Time frame: The analyses are conducted at time points before (day 0) and before every prescription of ICI (every 14 to 21 days) till progression or end of study at day 540
Detection of adverse events according to NCI CTAE (v4.0)
Time frame: From date of inclusion to the trial until the date of first documented iRECIST progression or date of death from any cause, whichever came first, assessed up to day 540.
Documentation of corticoid prescription
Time frame: From date of inclusion to the trial until the date of first documented iRECIST progression or date of death from any cause, whichever came first, assessed up to day 540.
Overall survival
Time frame: Till death of the patient or end of study at day 540, whichever came first
Progression free survival
Time frame: From date of inclusion to the trial until the date of first documented iRECIST progression or date of death from any cause, whichever came first, assessed up to day 540.
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