NEO-adjuvant Chemo-immunotherapy in Pancreatic Cancer

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

May 20, 2022

Primary Completion Date

June 30, 2024

Study Completion Date

June 30, 2026

Conditions
Pancreatic Cancer
Interventions
DRUG

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."

DRUG

Oxaliplatin

85mg/m2 intravenously on day 1

DRUG

Irinotecan

150mg/m2 intravenously on day 1

DRUG

Calcium folinate (leucovorin)

50mg as an intravenous bolus

DRUG

Fluorouracil

2400mg/m2 by continuous infusion via pump over 46 hours starting on day 1

DRUG

Pegylated G-CSF

6mg by subcutaneous injection to be given on day 3 of each cycle.

Trial Locations (3)

2065

GenesisCare North Shore, Sydney

2500

Wollongong Hospital, Wollongong

3084

Warringal Private Hospital, Melbourne

All Listed Sponsors
collaborator

The University of New South Wales

OTHER

collaborator

Walter and Eliza Hall Institute of Medical Research

OTHER

lead

Australasian Gastro-Intestinal Trials Group

NETWORK