Before inclusion (within 28 days prior inclusion) | DURING TREATMENT | End of treatment 30 days after the end of treatment (± 7 days) | Follow-up every 3 months up to progression | Overall survival after disease progression | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pre-operative treatment 4 | Before SURGERY | Post-operative treatment 5 | |||||||||||
D1 | D15 | D29 | D43 | Within 3 weeks before surgery | D1 | D15 | D29 | D43 | |||||
FLOT (q2w) Spartalizumab PDR001 (q4w) | ♦ ♦ | ♦ | ♦ ♦ | ♦ | ♦ ♦ | ♦ | ♦ ♦ | ♦ | No study visit is required. The following treatment/examns are at the discretion of physician | ||||
Signed Informed Consent before any study procedures | ✔ | ||||||||||||
Clinical assessment Physical examination including weight, ECOG, vital signs Adverse Events collection and concomitant treatments | ✔ | ✔ ✔ | ✔ ✔ | ✔ ✔ | ✔ ✔ | ✔ ✔ | ✔ ✔ | ✔ ✔ | ✔ ✔ | ✔ ✔ | ✔ ✔ | ✔ | |
Biological assessment Hematology and biochemistry1 | ✔ | ✔2,3 | ✔3 | ✔3 | ✔3 | ✔ | ✔3 | ✔3 | ✔3 | ✔3 | ✔ | ||
Uracilemia | ✔ | ||||||||||||
Urine or serum pregnancy test | ✔3 | ✔3 | ✔3 | ✔3 | |||||||||
Thyroid-function: TSH, free T4 | ✔ | ✔2 | ✔3 | ✔ | ✔3 | ✔3 | ✔ | ||||||
Tumor markers: CEA, CA 19.9 | ✔ | ✔2 | ✔ | ✔3 | ✔ | ||||||||
ECG | ✔ | ✔7 | ✔7 | ✔7 | ✔7 | ✔7 | ✔7 | ✔7 | ✔7 | ||||
CT-scan (thoracic and abdomino-pelvic) MRI optional | ✔ ✔ | ✔ ✔ | ✔ ✔ | ✔8 ✔ | |||||||||
Endoscopy | ✔9 | ✔ optional | |||||||||||
Blood samples for translational research10 | ✔ | ✔ | ✔ | ✔ | ✔6 |