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RecruitingLast updated:13 July 2022

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.

Age

People18+

Phase

II

Trial Acronym

NEO-IMPACT

More information

Trial Identifiers

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Commercial 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

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

Exclusion

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

Clinical trials have complex eligibility criteria.

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

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