Esophageal Cancer Stage III Clinical Trial
Official title:
PDL-1 Targeting in Resectable Oesophageal Cancer: a Phase II Feasibility Study of Atezolizumab and Chemoradiation.
Objectives The primary objective of this study is to assess the feasibility of preoperative treatment with atezolizumab combined with preoperative chemoradiation (carboplatin, paclitaxel and radiation) in terms of completion of treatment with atezolizumab.
Objectives The primary objective of the study of this study is to assess the feasibility of
preoperative treatment with atezolizumab combined with preoperative chemoradiation
(carboplatin, paclitaxel and radiation) in terms of completion of treatment with
atezolizumab.
Secondary objectives are:
- To assess toxicities of atezolizumab alone and in combination with chemoradiation.
- To assess completion of chemotherapy and radiation treatment
- To assess withdrawal rate from surgery
- To assess post-operative complications.
- To assess pathological response.
- To assess R0 resection rate.
- To assess the relation between gut microbiota composition and response.
- To assess the relation between gut microbiota composition and toxicity.
Explorative objectives are:
To perform exploratory biomarker analyses from tumor tissue and blood-derived samples and
correlate with safety and clinical outcome. Biomarker analyses include (but are not limited
to):
- Expression of PD-1, PD-L1 and FOXP3, presence of tumor infiltrating CD8+/CD4+
cytotoxic/helper T lymphocytes, IFNγ expression, presence of tumor macrophages, STAT3
and STAT6 expression, MHC classI, MHC class II, EBV and MSI status on tumor tissue.
- RNA sequencing and whole exome sequencing to develop a predictive profile for response
to treatment.
- Analysis of ctDNA extracted from plasma of patients at four time points (baseline,
directly after chemoradiation, at surgery and 3 months after surgery) and analyzed using
Ion Torrent Next Generation sequence technology as a non-invasive marker for response to
treatment.
- Analysis of peripheral blood mononuclear cells (PBMCs) extracted from whole blood of
patients at three time points ((baseline, directly after chemoradiation, at surgery) )
- Duodenal biopsy and morning faeces sample analysis as predictor of response will be done
by HIT Chip flora mapping, an established sensitive RT-qPCR method which is developed
for exact and sensitive enumeration of bacterial population.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00578201 -
FOLFOX-Cetuximab-radiotherapy for the Treatment of Esophageal Cancer
|
Phase 2 | |
| Not yet recruiting |
NCT03366883 -
Paclitaxel, Cisplatin,5-FU vs. Radiotherapy Plus Paclitaxel, Cisplatin as Preoperative Therapy for Locally Advanced ESC
|
Phase 3 |