A study to estimate the overall survival in real-life conditions in France of adult participants treated with nivolumab in combination with chemotherapy as first-line treatment for gastric and gastroesophageal junction cancer.
Study Type
OBSERVATIONAL
Enrollment
208
As prescribed by the treating clinician, as per product label
Local Institution - 0001
Paris, France
Kappa Santé
Paris, France
Overall survival (OS)
Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Cause of death (where available)
Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Disease progression
As assessed by the Site Investigator
Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Progression-free survival (PFS)
Time frame: Day 0 and months 2, 3, 4-6, 8-9, 12, 18, 24, 30 and 36
Time to treatment discontinuation (TTD)
Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Time to failure of strategy (TFS)
Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Time to next Treatment (TTNT)
Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Second progression-free survival (PFS2)
Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Treatment Free Interval (TFI)
Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Overall tumor response (ORR)
Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Response rate
Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Duration of response (DOR)
Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Participant socio-demographics
Time frame: Baseline
Participant clinical characteristics
Time frame: Baseline
Participant treatment history
Time frame: Baseline
Nivolumab treatment regime
Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Chemotherapy treatment regime
Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Reason for treatment discontinuation
Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Subsequent non-systemic treatment received post first-line treatment
Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Subsequent systemic treatment received post first-line treatment
Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Subsequent systemic treatment effectiveness
Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Participant adverse events (AEs)
Time frame: Up to 3 years
Participant health related quality of life as assessed by 5-level EuroQoL-5 dimension version (EQ-5D-5L)
Time frame: Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
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