Perioperative Immunotherapy vs. Chemo-immunotherapy in Patients With Advanced GC and AEG
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 88
Summary
- Conditions
- Adenocarcinoma of the Esophagogastric Junction
- Gastric Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This study will determine the rate of pathological complete responses (pCR) as determined by pathological examination of the resected tumor following preoperative systemic therapy. A pCR rate of 15% is expected with neoadjuvant FLOT chemotherapy. An increase to 35% is estimated to be clinically rele...
This study will determine the rate of pathological complete responses (pCR) as determined by pathological examination of the resected tumor following preoperative systemic therapy. A pCR rate of 15% is expected with neoadjuvant FLOT chemotherapy. An increase to 35% is estimated to be clinically relevant when patients are treated with either nivolumab in combination with chemotherapy (Arm B) or nivolumab and another immuno-oncology (IO) agent (relatlimab) in Arm D. Additional objectives include resection rate, diseasefree survival (DFS), median overall survival (OS), patient's quality of life (QoL), and safety and tolerability of the treatment. Furthermore, translational endpoints will be investigated.
Tracking Information
- NCT #
- NCT04062656
- Collaborators
- GWT-TUD GmbH
- Investigators
- Principal Investigator: Stefan Kasper-Virchow, Prof. University Hospital, Essen
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