EU Clinical Trial 2018-000383-28

Perioperative chemotherapy vs. immunotherapy vs. chemo-immunotherapy stratified by early response evaluation in patients with advanced gastric cancer (GC) and adenocarcinoma of the esophago-gastric junction (AEG) (IMAGINE)  May 23, 2019

Main objective of the trial: Primary endpoint is 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 in Arm A with FLOT chemotherapy based on the results of the FLOT4 trial. An increase to 35% in Arm B or C is assumed to be clinically relevant. Ziel dieser Studie ist es, die Rate der pathologischen Komplettremissionen (pCR) in den vier Behandlungsarmen zu bestimmen. Basierend auf den Ergebnissen der FLOT4-Studie wird eine pCR-Rate von 15% in Arm A mit neoadjuvanter FLOT-Chemotherapie erwartet. Eine Erhöhung auf 35% in Arm B, C oder D wird als klinisch relevant angenommen.

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Keywords
5-Fluorouracil CALCIUM FOLINATE Docetaxel Docetaxel-ratiopharm® 20 mg/ml ELOXATIN® 5 mg/ml Fluorouracil Fluorouracil-GRY® 50 mg/ml Gastric cancer Gastroesophageal cancer IPILIMUMAB Leucovorin 10 mg/ml Nivolumab OPDIVO® (100mg/10ml) OXALIPLATIN Oesophageal cancer Relatlimab Yervoy ®

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Source:  EMA Last updated:  May 30, 2019

From ClinicalTrialsRegister.eu, a database of the European Medicines Agency. This record may not reflect the most current and accurate data available from the EMA.