NEO-adjuvant Chemo-immunotherapy in Pancreatic Cancer

Sponsor
Australasian Gastro-Intestinal Trials Group
Study ID
NCT06094140
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    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 — DRUG
    85mg/m2 intravenously on day 1
  • Irinotecan — DRUG
    150mg/m2 intravenously on day 1
  • Calcium folinate (leucovorin) — DRUG
    50mg as an intravenous bolus
  • Fluorouracil — DRUG
    2400mg/m2 by continuous infusion via pump over 46 hours starting on day 1
  • Pegylated G-CSF — DRUG
    6mg by subcutaneous injection to be given on day 3 of each cycle.

Study Details

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

Key Dates

Start date
May 20, 2022
Status verified
May 2026
Primary completion
Jun 30, 2024
Completion
Jun 30, 2026

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single arm study, mFOLFIRINOX and durvalumab, neoadjuvant resectable pancreatic cancer.
    All patients enrolled to this study will receive mFOLFIRINOX, delivered Q2W for 6 cycles and durvalumab delivered Q4W for 3 cycles in the neoadjuvant setting for resectable or borderline resectable pancreatic cancer patients. Patients will then undergo restaging, discussion at MDM and surgical resection where appropriate. Following resection, patients will commence 6 cycles of adjuvant mFOLFIRINOX alone (or gemcitabine-based chemotherapy if deemed by investigator as more appropriate). Patients will be followed up on study for 12 months from surgery, or from completion of neoadjuvant

Primary Outcome Measure

The proportion of patients receiving at least 80% of planned neoadjuvant treatment. [ Time Frame: At completion of neo-adjuvant treatment (at 3 months post enrollment) ]

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