Active — Not RecruitingPhase 2

NEO-adjuvant Chemo-immunotherapy in Pancreatic Cancer

Australia20 participantsStarted 2022-05-20

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Adults, aged 18 years and older, with cytologically or histologically proven resectable or borderline resectable pancreatic adenocarcinoma as per Australasian Gastro-Intestinal Trials Group (AGITG) consensus guidelines. Those in whom cytology is suspicious for pancreatic adenocarcinoma but not diagnostic may be allowed on study following discussion with the study chair (or their representative).
✓. ECOG 0-1
✓. Adequate normal organ and marrow function as defined below:
✓. Study treatment both planned and able to start within 14 days of registration.
✓. Body weight \>30 kg.
✓. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
✓. Must have a life expectancy of at least 12 weeks.
✓. Tumor assessment by computed tomography (CT) scan or magnetic resonance imaging (MRI) must be performed within 28 days prior to first study treatment.

Exclusion criteria

✕. Locally advanced or metastatic pancreatic adenocarcinoma.
✕. Neuroendocrine pancreatic carcinoma.
✕. Prior treatment for pancreatic cancer including chemotherapy, checkpoint inhibitor or investigational treatments, the exception of a maximum of 1 cycle of neoadjuvant intent mFOLFIRINOX.
✕. Participation in another clinical study with an investigational product during the last 30 days.
✕. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or enrolment occurs during the follow-up period.
✕. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
✕. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
✕. History of allogenic organ transplantation.

What they're measuring

The proportion of patients receiving at least 80% of planned neoadjuvant treatment.

Timeframe: At completion of neo-adjuvant treatment (at 3 months post enrollment)

Trial details

NCT IDNCT06094140

SponsorAustralasian Gastro-Intestinal Trials Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2024-06-30

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