Blood-borne assessment of stromal activation in esophageal adenocarcinoma to guide tocilizumab therapy: a randomized phase II proof-of-concept study (BASALT)

Conditions

Esophageal adenocarcinoma, esophageal cancer

Brief summary

The primary endpoint is pathological response to chemoradiotherapy according to the Mandard criteria.

Detailed description

Secondary endpoints are:  R0 resection rate.  Progression free survival  Overall survival  IL-6-STAT3 pathway inhibition based on gene expression analysis  pSTAT3 and stromal abundance in formalin-fixed paraffin-embedded tumor tissue  Levels of IL-6 in serum.  Levels of ADAM12 in tumor biopsies and serum in relation to pathological response according to the Mandard criteria.  Incidence and severity of toxicity defined according to CTCAE v5.0 and Radiation Oncology Group (RTOG) criteria.,  Incidence and severity of post-operative complications according to the Dindo classification.  Percentage completion of chemotherapy and radiation treatment  Percentage withdrawal rate from surgery due to tocilizumab related complications  Percentage delay of surgery due to tocilizumab related complications

Related papers

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Interventions

DRUGTOCILIZUMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is pathological response to chemoradiotherapy according to the Mandard criteria.	—

Secondary

Measure	Time frame
Secondary endpoints are:  R0 resection rate.  Progression free survival  Overall survival  IL-6-STAT3 pathway inhibition based on gene expression analysis  pSTAT3 and stromal abundance in formalin-fixed paraffin-embedded tumor tissue  Levels of IL-6 in serum.  Levels of ADAM12 in tumor biopsies and serum in relation to pathological response according to the Mandard criteria.  Incidence and severity of toxicity defined according to CTCAE v5.0 and Radiation Oncology Group (RTOG) criteria.,  Incidence and severity of post-operative complications according to the Dindo classification.  Percentage completion of chemotherapy and radiation treatment  Percentage withdrawal rate from surgery due to tocilizumab related complications  Percentage delay of surgery due to tocilizumab related complications	—

Measure

Time frame

Secondary endpoints are:  R0 resection rate.  Progression free survival  Overall survival  IL-6-STAT3 pathway inhibition based on gene expression analysis  pSTAT3 and stromal abundance in formalin-fixed paraffin-embedded tumor tissue  Levels of IL-6 in serum.  Levels of ADAM12 in tumor biopsies and serum in relation to pathological response according to the Mandard criteria.  Incidence and severity of toxicity defined according to CTCAE v5.0 and Radiation Oncology Group (RTOG) criteria.,  Incidence and severity of post-operative complications according to the Dindo classification.  Percentage completion of chemotherapy and radiation treatment  Percentage withdrawal rate from surgery due to tocilizumab related complications  Percentage delay of surgery due to tocilizumab related complications

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Countries

Netherlands

Outcome results

None listed