Open-label non-randomized multicentric phase 2 study evaluating the combination of bemarituzumab + FLOT chemotherapy in perioperative setting for resectable stage cT2-T4a or N+ gastric and GEJ adenocarcinoma overexpressing FGFR2b (BEMAFLOT)

gastric and gastro-oesophageal junction adenocarcinomas

the complete pathological response in histological result of primary tumour and lymph nodes from the surgical resection, using Becker tumour resection grading (21).

Adverse Events (AE), Serious Adverse Events (SAE), assessed by CTCAE version 5.0 and specific grading for ocular toxicity cf. section .9.1.1 (start, imputability), Post-operative complications, graded using Clavien-Dindo scale, between surgery and 30 days postoperative, Histological results of the primary tumour and lymph nodes from the surgical resection, using Becker tumour grading, • Vital status throughout the 5 years follow-up • TDM every 3 months for 2 years and every 6 months until 5 years of follow-up. Recurrence is defined according to RECIST 1.1., • Vital status throughout the 5 years follow-up • TDM every 3 months for 2 years and every 6 months until the 5-years-follow-up. Recurrence is defined according RECIST 1.1., EORTC QLQ-C30 at C1D1, after surgery, at the end of treatment (EOT) visit and then every 6 months for 5 years., The nutritional status assessment will be assessed by Mini Nutritional Assessment (MNA)(23), at C1D1, after surgery, at the EOT visit and every 6 months for 5 years. The MNA (23–26) provided a global score of nutritional status from 0 to 30 and identify 3 categories: normal (≥24), at risk of malnutrition (≥17) and malnourished (<17)., • The expression of FGFR2b is measured prior to inclusion in the trial, during the screening period. • Vital status throughout the 5 years follow-up • TDM every 3 months for 2 years and every 6 months until the 5-years-follow-up. Recurrence is defined according RECIST 1.1.

No related papers found yet.

France