20
Participants
Start Date
May 20, 2022
Primary Completion Date
June 30, 2024
Study Completion Date
June 30, 2026
Durvalumab
"Durvalumab will be supplied by AstraZeneca as a 500 mg vial concentrate for solution for infusion. The solution contains 50 mg/mL durvalumab, 26 mM histidine/histidine-hydrochloride, 275 mM trehalose dihydrate, and 0.02% weight/volume (w/v) polysorbate 80; it has a pH of 6.0 and density of 1.054 g/mL. The label-claim volume is 10 mL.~Durvalumab is a sterile, clear to opalescent, colorless to slightly yellow solution, free from visible particles.~Investigational product vials are stored at 2°C to 8°C (36°F to 46°F) and must not be frozen. Investigational product must be kept in original packaging until use to prevent prolonged light exposure."
Oxaliplatin
85mg/m2 intravenously on day 1
Irinotecan
150mg/m2 intravenously on day 1
Calcium folinate (leucovorin)
50mg as an intravenous bolus
Fluorouracil
2400mg/m2 by continuous infusion via pump over 46 hours starting on day 1
Pegylated G-CSF
6mg by subcutaneous injection to be given on day 3 of each cycle.
GenesisCare North Shore, Sydney
Wollongong Hospital, Wollongong
Warringal Private Hospital, Melbourne
The University of New South Wales
OTHER
Walter and Eliza Hall Institute of Medical Research
OTHER
Australasian Gastro-Intestinal Trials Group
NETWORK