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NEO-adjuvant Chemo-immunotherapy in Pancreatic Cancer

NCT06094140 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-06

No results posted yet for this study

Summary

To determine the safety and tolerability of adding durvalumab to mFOLFIRINOX prior to surgery in patients with resectable or borderline resectable pancreatic adenocarcinoma.

Conditions

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.

Sponsors & Collaborators

  • The University of New South Wales

    collaborator OTHER

  • Walter and Eliza Hall Institute of Medical Research

    collaborator OTHER

  • Australasian Gastro-Intestinal Trials Group

    lead NETWORK

Principal Investigators

  • Lorraine Chantrill, Professor · AGITG

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-20
Primary Completion
2024-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06094140 on ClinicalTrials.gov