Study: NCT05286814

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Oxaliplatin
Description: IV systemic chemotherapy on D1 and D15 of every cycle, beginning C2D1; treatment assigned by Arm. Arm 1: either FOLFOX (leucovorin, 5-FU and oxaliplatin) or FOLFIRI (leucovorin, 5-FU and irinotecan); FOLFOX: oxaliplatin (85 mg/m2) and leucovorin (400 mg/m2) administered concurrently via Y-Line over 120 minutes, then a 46-hour infusion of 5-FU (2000 mg/m2) administered via an ambulatory device on site. Arm 2: GemOx (gemcitabine \[800 mg/m2 IV over 30 minutes\] and oxaliplatin \[85 mg/ m2 IV over 120 minutes\])

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Oxaliplatin
Description: IV systemic chemotherapy on D1 and D15 of every cycle, beginning C2D1; treatment assigned by Arm. Arm 1: either FOLFOX (leucovorin, 5-FU and oxaliplatin) or FOLFIRI (leucovorin, 5-FU and irinotecan); FOLFOX: oxaliplatin (85 mg/m2) and leucovorin (400 mg/m2) administered concurrently via Y-Line over 120 minutes, then a 46-hour infusion of 5-FU (2000 mg/m2) administered via an ambulatory device on site. Arm 2: GemOx (gemcitabine \[800 mg/m2 IV over 30 minutes\] and oxaliplatin \[85 mg/ m2 IV over 120 minutes\])

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Leucovorin
Description: IV systemic chemotherapy on D1 and D15 of every cycle, beginning C2D1; treatment assigned by Arm. Arm 1: will receive either FOLFOX (leucovorin, 5-FU and oxaliplatin) or FOLFIRI (leucovorin, 5-FU and irinotecan); FOLFOX: oxaliplatin (85 mg/m2) and leucovorin (400 mg/m2) administered concurrently via Y-Line over 120 minutes, then a 46-hour infusion of 5-FU (2000 mg/m2) administered via an ambulatory device on site. FOLFIRI: irinotecan (150 mg/m2) and leucovorin (400 mg/m2) administered concurrently via Y-Line over 30 minutes, then a 46-hour infusion of 5-FU (2000 mg/m2) administered via an ambulatory device on site.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Leucovorin
Description: IV systemic chemotherapy on D1 and D15 of every cycle, beginning C2D1; treatment assigned by Arm. Arm 1: will receive either FOLFOX (leucovorin, 5-FU and oxaliplatin) or FOLFIRI (leucovorin, 5-FU and irinotecan); FOLFOX: oxaliplatin (85 mg/m2) and leucovorin (400 mg/m2) administered concurrently via Y-Line over 120 minutes, then a 46-hour infusion of 5-FU (2000 mg/m2) administered via an ambulatory device on site. FOLFIRI: irinotecan (150 mg/m2) and leucovorin (400 mg/m2) administered concurrently via Y-Line over 30 minutes, then a 46-hour infusion of 5-FU (2000 mg/m2) administered via an ambulatory device on site.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PDS01ADC
Description: PDS01ADC will be administered by subcutaneous injection on Day 15 of every cycle. Cycle 1 at 12 mcg/kg; Cycle 2 reduced to 8 mcg/kg with the addition of systemic chemotherapy, to continue for further cycles. Note: any dose reduction in FUDR = 50% due to liver enzyme elevations means that the dose of PDS01ADC will be reduced to 4 mcg/kg.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PDS01ADC
Description: PDS01ADC will be administered by subcutaneous injection on Day 15 of every cycle. Cycle 1 at 12 mcg/kg; Cycle 2 reduced to 8 mcg/kg with the addition of systemic chemotherapy, to continue for further cycles. Note: any dose reduction in FUDR = 50% due to liver enzyme elevations means that the dose of PDS01ADC will be reduced to 4 mcg/kg.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gemcitabine
Description: IV systemic chemotherapy on D1 and D15 of every cycle, beginning C2D1; treatment assigned by Arm. Arm 2: GemOx (gemcitabine \[800 mg/m2 IV over 30 minutes\] and oxaliplatin \[85 mg/ m2 IV over 120 minutes\])

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: HAIP FUDR and Dexamethasone treatment on D1 of every cycle. Dexamethasone: (1 mg/day X pump volume / pump flow rate)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: HAIP FUDR and Dexamethasone treatment on D1 of every cycle. Dexamethasone: (1 mg/day X pump volume / pump flow rate)