Clinical Trials Logo
  1. Home
  2. Esophageal Adenocarcinoma
  3. NCT04554771

Blood-borne Assessment of Stromal Activation in Esophageal Adenocarcinoma to Guide Tocilizumab Therapy — BASALT  

Esophageal Adenocarcinoma Clinical Trial

Official title:
Blood-borne Assessment of Stromal Activation in Esophageal Adenocarcinoma to Guide Tocilizumab Therapy: a Randomized Phase II Proof-of-concept Study

Clinical Trial 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.

Clinical Trial Description

Randomized phase II proof-of-concept study with tocilizumab and standard of care paclitaxel, carboplatin and radiation followed by surgical resection of the oesophagus for patients with surgically resectable adenocarcinomas of the oesophagus or oesophageal junction. Patients will be grouped for serum ADAM12 with a cutoff of 203 ng/mL. Patients in both groups will be randomized to receive tocilizumab 8mg/kg on day 1, 15 and 29 or not in addition to paclitaxel 50mg/m2, carboplatin dosed with area under the curve (AUC) 2 on day 1, 8, 15, 22 and 29 and radiation 41.4 Gy in 23 fractions. Surgery will be planned approximately in week 13-15, which is 8 to 10 weeks after the end of chemoradiation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04554771
Study type Interventional
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact
Status Active, not recruiting
Phase Phase 2
Start date January 27, 2021
Completion date January 1, 2024
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04159974 - RICE: Radio-Immuno-Chemotherapy of Cancer of the Esophagus Phase 2
Completed NCT03015389 - Wide Area Transepithelial Sample Esophageal Biopsy Combined With Computer Assisted 3-Dimensional Tissue Analysis (WATS3D) For the Detection of High Grade Esophageal Dysplasia and Adenocarcinoma
Terminated NCT04642690 - Nitrates and IL-8 in Barrett's Esophagus
Withdrawn NCT03982173 - Basket Trial for Combination Therapy With Durvalumab (Anti-PDL1) (MEDI4736) and Tremelimumab (Anti-CTLA4) in Patients With Metastatic Solid Tumors Phase 2
Completed NCT02128243 - Trial of S-1 Maintenance Therapy in Metastatic Esophagogastric Cancer Phase 2
Recruiting NCT04430738 - Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers Phase 1/Phase 2
Recruiting NCT04114136 - Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies Phase 2
Terminated NCT03223662 - Metabolomic and BH3 Profiling of Esophageal Cancers: Identification of Novel Assessment Methods of Treatment Response for Precision Therapy Phase 2
Recruiting NCT05530343 - Seattle Biopsy Protocol Versus Wide-Area Transepithelial Sampling in Patients With Barrett's Esophagus Undergoing Surveillance N/A
Active, not recruiting NCT03539822 - Cabozantinib Plus Durvalumab With or Without Tremelimumab in Patients With Gastroesophageal Cancer and Other Gastrointestinal Malignancies Phase 1/Phase 2
Recruiting NCT05902988 - A Phase I/II Study of VLS-1488 in Subjects With Advanced Cancer Phase 1/Phase 2
Completed NCT01970306 - Evaluate Esophageal Reinforcement With ACell MatriStem Surgical Matrix: A Degradable Biologic Scaffold Material Phase 2
Recruiting NCT06071845 - Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples N/A
Active, not recruiting NCT02872116 - Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer Phase 3
Completed NCT04089904 - Phase II Trial of Neoadjuvant Pembrolizumab for Patients With Early Stage Gastroesophageal Adenocarcinoma Phase 2
Recruiting NCT05177133 - Anti-PD-1 and CapOx for the First-line Treatment of dMMR Esophagogastric Cancer (AuspiCiOus) Phase 2
Recruiting NCT02962063 - Durvalumab, an Anti-PDLI Antibody, and Tremelimumab, an Anti-CTLA4 Antibody, and Chemoradiation Before Surgery for Esophageal Cancer Phase 1/Phase 2
Recruiting NCT02606396 - Cryotherapy for Malignant Dysphagia in Patients With Advanced Esophageal Cancer N/A
Completed NCT02610764 - Pilot Sudy: Resectable Esophageal Adenocarcinoma and the Relevance of CTC N/A
Terminated NCT00430027 - Preoperative Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy for Locally Advanced Esophageal Adenocarcinoma N/A