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Inhibitors of the programmed cell death protein 1 (PD-1)/PD-L1 immune checkpoint signaling pathway are already approved in the treatment of various tumor entities in relapsed or metastatic stages. Different exploratory trials suggest that the combination of radiotherapy and PD-1/PD-L1 inhibitors is highly effective, especially in oligometastatic stages and if all lesions are treated with ablative radiotherapy. In addition, the role of predictive biomarkers is becoming increasingly important for future therapy algorithms. First data, also from our group, indicate clearly that dynamic changes of immune cells and their activation markers in the peripheral blood (immune matrix) can be used as predictive biomarkers. During the planned STICI-02 trial predictive immune matrix derived from the STICI01 trial (NCT03453892) will be validated in the groups of patient suffering from HNSCC (palliative), NSCLC (separately palliative and adjuvant) and "other solid tumors" (including in particular esophageal carcinomas, urothelial and renal carcinomas, small cell bronchial carcinomas and squamous cell carcinomas of the skin [depending on the current drug approval]). Within the framework of scientific accompanying projects, the predictive value of markers in tumor tissue and of pattern radiomics analyses will be analyzed accompanying the immunophenotyping in peripheral blood. The side effects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trial cohort | The study cohort consist of patients suffering from HNSCC (palliative), NSCLC (separately palliative and adjuvant) and "other solid tumors" (including in particular esophageal carcinomas, urothelial and renal carcinomas, small cell bronchial carcinomas and squamous cell carcinomas of the skin [depending on the current drug approval]) which will be treated with ICI (PD-1/PD-L1) and potential radiation of metastases at Department of Radiation Oncology of Universitätsklinikum Erlangen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional Therapy acc. to prevailing clincal approved schemes | Other | The study is observational. The treatment-plan of the underlying disease remains unchanged. The treatment of the patient is according to the prevailing clinical approved schemes at the respective entities. Blood will be drawn from patients at several time points during and after RT and ICI for detailed immunomonitoring of the patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Overallsurvival | Prospective investigation of the survival of the patients. | From inclusion till death of subject or up to 5 years, whichever came first. |
| Longitudinal Immunophenotype | Longitudonal Immunophenotyping of the patients: Detection of about 30 distinct immune cell (sub)types together with their activation markers during treatement. | Day 0 till progression or end of study up to 5 years or till change to conventional treatment without ICI, whichever came first. |
| Predictors in pattern recognition analyses | Identification of possible predictors in pattern recognition analyses from clinical imaging data sets. | Day 0 till progression or end of study up to 5 years or till change to conventional treatment without ICI, whichever came first. |
| Immune-associated side effects | Detection of immune-associated side effects | Day 0 till progression or end of study up to 5 years or till change to conventional treatment without ICI, whichever came first. |
| Measure | Description | Time Frame |
|---|---|---|
| Detection of adverse events according to NCI CTAE (v4.0) | The adverse effects of Immunecheckpoint and Radiotherapy is recorded by official questionaire | From date of inclusion to the trial until the date of first documented iRECIST progression or date of death from any cause, or till change to conventional treatment , whichever came first, assessed up to 5 years. |
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Inclusion Criteria:
Exclusion Criteria:
Both gender are included into the study, a maximum age was not defined.
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The study cohort consist of patients suffering from HNSCC (palliative), NSCLC (separately palliative and adjuvant) and "other solid tumors" (including in particular esophageal carcinomas, urothelial and renal carcinomas, small cell bronchial carcinomas and squamous cell carcinomas of the skin [depending on the current drug approval]) which will be treated with ICI (PD-1/PD-L1) and potential radiation of metastases at Department of Radiation Oncology of Universitätsklinikum Erlangen.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Markus Hecht, PD Dr. | Contact | +49 9131 85 | 44247 | markus.hecht@uk-erlangen.de |
| Benjamin Frey, PD Dr. Dr. | Contact | +49 9131 85 | 44248 | benjamin.frey@uk-erlangen.de |
| Name | Affiliation | Role |
|---|---|---|
| Markus Hecht, PD Dr. | Universitätsklinikum Erlangen, Department of Radiation Oncology | Study Director |
| Udo S Gaipl, Prof. Dr. | Universitätsklinikum Erlangen, Department of Radiation Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiation Oncology, Universitätsklinikum Erlangen | Recruiting | Erlangen | Bavaria | 91054 | Germany |
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blood, serum, plasma, immunecell RNA, immunecell DNA
|
| Progression free survival | survival of the patient without progression of malignant disesase | 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 5 yeras |
| Treatment response (according to RECIST and iRECIST criteria) | RECIST and iRECIST criteria will used to analyse the response of the patient to the respective treatement | 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 5 years |
| Attempt to establish an immune matrix of responding/non-responding patients | Analysis of clincal, MRI and imunnologic, molecular data to develop an biomarkermatrix with processes of machine learning | 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 up to 5 years or till change to conventional treatment without ICI. |
| Rainer Fietkau, Prof. Dr. | Universitätsklinikum Erlangen, Department of Radiation Oncology | Study Chair |
| Benjamin Frey, PD Dr. Dr. | Universitätsklinikum Erlangen, Department of Radiation Oncology | Principal Investigator |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D004938 | Esophageal Neoplasms |
| D002295 | Carcinoma, Transitional Cell |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D000230 | Adenocarcinoma |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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