Perioperative treatment in resectable gastric cancer with spartalizumab in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT): a phase II study (GASPAR)

Table 3 Overview of study assessments of the GASPAR trial

	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

¹ CBC-platelets, Creatininemia, kaliema, magnesemia, calcemia, albumin, glycemia, lipase, bilirubin, ALT, AST, GGT
² Only if realized more 3 days before D1
³ Within 3 days before treatment administration
⁴ The initial combination treatment by FLOT regimen plus Spartalizumab should be initiated within 7 days after inclusion
⁵ The combination treatment by FLOT regimen plus Spartalizumab should be initiated within 4–10 weeks after surgery
⁶ Blood sample only for follow-up at 3 months
⁷ To be realized before and after oxaliplatin intravenous infusion
⁸ Every 3 months for the first 2 years and every 6 months for the next 3 years
⁹ Within 6 weeks prior to inclusion with available archival tumor (otherwise, fresh tumor) And optional fresh tumor biopsies only at François Baclesse site for organoids research (additional specific consent form)
¹⁰ Mandatory blood samples for ctDNA
And optional PBMC at baseline only at François Baclesse site for organoids research (additional specific consent form)

ISSN: 1471-2407