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RecruitingLast updated: 2 February 2024

NEO-IMPACT: This phase II study is trying to understand how safe and effective combining standard chemotherapy (mFOLFIRINOX) with immunotherapy (durvalumab) is in people with early stage pancreatic cancer who are considered suitable for surgeryInvestigating the safety and efficacy of NEO-adjuvant chemo-IMmunotherapy in PAnCreaTic cancer, NEO-IMPACT.

Clinical summary

Summary

Eligible participants will receive 6 treatment cycles every 2 weeks of combined immuno-chemotherapy (durvalumab with modified FOLFIRINOX). mFOLFIRINOX will be administered as a day patient in hospital, given via intravenous infusion (IV) on day 1 of each cycle. One of the chemotherapy drugs (5-FU) will be given as a continuous infusion over 46 hours via portable pump, so participants will return to hospital on day 3 to have this pump disconnected. Durvalumab will be given via IV on Day 1 of each second cycle. At the end of the 6 treatment cycles, participants will be assessed for their suitability for surgery. After surgery, all participants will then receive an additional 6 treatment cycles of chemotherapy (mFOLFIRINOX) alone.

Cancer

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18+

Phase

II

Trial Acronym

NEO-IMPACT

More information

Trial Identifiers

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Trial sponsor

Australasian Gastro-Intestinal Trials Group (AGITG)

Scientific Title

Investigating the safety and efficacy of NEO-adjuvant chemo-IMmunotherapy in PAnCreaTic cancer, NEO-IMPACT.

Eligibility

Inclusion

Pancreatic adenocarcinoma proven by histology or cytology that is resectable or borderline resectable.
Good performance status (ECOG 0 - 1)
Adequate kidney, liver and bone marrow function to be able to undergo immuno-chemotherapy
Body weight above 30kg
Life expectancy of at least 12 weeks
Tumour lesion on CT or MRI scan that is measurable

Exclusion

Locally advanced or metastatic pancreatic adenocarcinoma.
Neuroendocrine pancreatic carcinoma.
Prior treatment for pancreatic cancer (including another clinical trial).
Major surgical procedure within 28 days prior to the first dose of immuno-chemotherapy.
History of allogenic organ transplantation.
Active or prior autoimmune or inflammatory disorders such as inflammatory bowel disease (eg. colitis, Crohn's disease), systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome (granulomatosis with polyangitis, Graves disease, rheumatoid arthritis, hypophysitis, uveitis).
Uncontrolled intercurrent illness (such as ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrheoa, psychiatric illness/social situations that would limit compliance with study requirements).
History of another primary malignancy (except malignancy treated with curative intent and with no know active disease for more than 5 years, or adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease or adequately treated carcinoma insitu without evidence of disease or history of leptomeningeal carcinomatosis or history of active primary immunodeficiency).
Active infection with TB, hepatitis B or hepatitis C.
HIV positive.
Current or prior use of immunosuppressive medication within 14 days before the first dose of immunotherapy.
Receipt of live attenuated vaccine within 30 days prior to the first dose of immuno-chemotherapy.
Patients who are pregnant or breast-feeding.
Patients or partners of patients, who are of reproductive potential and are unwilling to use effective birth control from screening to 90 days after the last dose of immunotherapy.
Known allergy or hypersensitivity to any of the drugs (immuno-chemotherapy) used or their excipients.


Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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