Clinical trial • Phase I | Phase III • Oncology | Gastroenterology
tislelizumab for Esophagogastric adenocarcinoma | Gastroesophageal cancer
Phase I | Phase III trial of tislelizumab for Esophagogastric adenocarcinoma | Gastroesophageal cancer. 18 participants.
Overview
- Trial Therapeutic Area
- Oncology | Gastroenterology
- Trial Disease
- Esophagogastric adenocarcinoma | Gastroesophageal cancer
- Trial Stage
- Phase I | Phase III
- Drug Modality
- Monoclonal antibody | Small molecule
Key dates
- Initial CTIS Submission Date
- 30-05-2025
- First CTIS Authorization Date
- 27-08-2025
Trial design
Phase I | Phase III trial across 5 sites in Germany.
- Target Sample Size
- 18
Eligibility
Recruits 18 Vulnerable population selected; no further details on consent or assent available..
- Vulnerable Population
- Vulnerable population selected; no further details on consent or assent available.
Recruitment
- Planned Sample Size
- 18
- Recruitment Window Months
- 30
Geography
- Total Number Of Sites
- 5
- Total Number Of Participants
- 18
Germany
- Earliest CTIS Part Ii Submission Date
- 22-07-2025
- Latest Decision Or Authorization Date
- 30-01-2026
- Processing Time Days
- 192
- Number Of Sites
- 5
- Number Of Participants
- 18
Sites
- Site Name
- Krankenhaus Nordwest GmbH
- Department Name
- Institut für Klinisch-Onkologische Forschung (IKF)
- Principal Investigator Name
- Thorsten Götze
- Principal Investigator Email
- goetze.thorsten@khnw.de
- Contact Person Name
- Thorsten Götze
- Contact Person Email
- goetze.thorsten@khnw.de
- Site Name
- Universitaet Leipzig
- Department Name
- Medizinische Klinik 2 (Onkologie, Gastroenterologie, Hepatologie, Pneumologie)
- Principal Investigator Name
- Gertraud Stocker
- Principal Investigator Email
- stocker.studienmails@medizin.uni-leipzig.de
- Contact Person Name
- Gertraud Stocker
- Contact Person Email
- stocker.studienmails@medizin.uni-leipzig.de
- Site Name
- Haematologisch Onkologische Praxis Eppendorf / Norddeutsches Studienzentrum für Innovative Onkologie
- Department Name
- Norddeutsches Studienzentrum für Innovative Onkologie
- Principal Investigator Name
- Alexander Stein
- Principal Investigator Email
- stein@hope-hamburg.de
- Contact Person Name
- Alexander Stein
- Contact Person Email
- stein@hope-hamburg.de
- Site Name
- Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
- Department Name
- Med. Klinik und Poliklinik III Hämatologie und Onkologie
- Principal Investigator Name
- Sylvie Lorenzen
- Principal Investigator Email
- Sylvie.Lorenzen@mri.tum.de
- Contact Person Name
- Sylvie Lorenzen
- Contact Person Email
- Sylvie.Lorenzen@mri.tum.de
- Site Name
- Asklepios Kliniken Hamburg GmbH
- Department Name
- Asklepios Tumorzentrum Hamburg, Klinik Altona
- Principal Investigator Name
- Dirk Arnold
- Principal Investigator Email
- d.arnold@asklepios.com
- Contact Person Name
- Dirk Arnold
- Contact Person Email
- d.arnold@asklepios.com
Sponsor
Primary sponsor
- Full Name
- Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- Tislelizumab
- Active Substance
- tislelizumab
- Modality
- Monoclonal antibody
- Investigational Product Name
- FLOT chemotherapy regimen (5‑fluorouracil, leucovorin, oxaliplatin, docetaxel)
- Active Substance
- 5‑fluorouracil; leucovorin; oxaliplatin; docetaxel
- Modality
- Small molecule
- Combination Treatment
- Yes
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