drugset / Trial / NCT04554771
Blood-borne Assessment of Stromal Activation in Esophageal Adenocarcinoma to Guide Tocilizumab Therapy
Phase 2
Active not recruiting
41 enrolled
Academic Medical Center - University of Amsterdam
Noordwest Ziekenhuisgroep · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of this study is to demonstrate that stroma-targeting by tocilizumab in patients with adenocarcinoma of the esophagus or gastroesophageal junction with highly activated stroma increases efficacy of chemoradiotherapy measured by pathological response according to the Mandard criteria. Patients will be grouped for ADAM12, a non-invasive blood-borne marker of stromal activation.
Timeline
- Start
- 2021-01-27
- Primary completion
- 2022-10-10
- Completion
- 2028-04-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tocilizumab | Monoclonal antibody | 8 mg/kg | Intravenous |
| Background | Carboplatin | Small molecule | — | Intravenous |
| Background | Paclitaxel | Small molecule | 50 mg/m2 | Intravenous |