Trial summary: This study aims to improve symptoms and visceral pain levels, as well as treatment efficacy for patients with non-resectable pancreatic cancer by restoring a healthy microbiota, gut barrier and digestion through fecal microbiota transplantation (FMT) as a co-treatment to chemotherapy.
Status: OPEN - Recruiting
Trial identifier: ACTRN12624000455561
Phase: I
Diagnosis: Locally advanced (Stage III) unresectable or Metastatic (Stage IV) pancreatic ductal adenocarcinoma
Line of therapy: First-line
Treatment: Fecal Microbiota capsules (oral) in combination with chemotherapy
  • Key inclusion criteria
    • Adults aged between 18 and 75 years of age
    • Seen by a participating clinician for their first assessment between the study start date and the end of recruitment date
    • Administered Abraxane-Gemcitabine or Folfirinox as a chemotherapy agent
    • Performance status ECOG PS 0-1
    • Presenting an adequate bone marrow function with neutrophils > 1.5 × 109/l within 7 days of enrolment
    • Presenting an adequate renal function, with calculated creatinine clearance > 40 ml/min (Cockcroft and Gault) within 7 days of enrolment
    • Presenting an adequate hepatic function with serum total bilirubin < 1.25 × upper limit of normal range and ALT or AST < 2.5 × ULN (< 5 × ULN if liver metastases present) within 7 days of enrolment
    • Presenting a magnesium ≥ lower limit of normal within 7 days of enrolment
    • With a life expectancy of at least 12 weeks
    • Returning a negative pregnancy test ≤ 72 hours before commencing study treatment (women of childbearing potential only)
    • Speaking English or attending appointments accompanied with an English speaking next of kin
    • Able to provide a signed informed consent
    • Willing and able to comply with all study requirements, including treatment timing and nature of required assessments
  • Key exclusion criteria
    • Aged under 18 years old or over 75 years old at first assessment
    • With resectable pancreatic tumour (including borderline resectable) who are predicted to receive surgery
    • Already receiving chemotherapy treatment either for pancreatic cancer or another cancer
    • Who have already received chemotherapy treatment for pancreatic cancer
    • With prior pelvic radiotherapy, systemic chemotherapy, immunotherapy, approved proteins/antibodies or any investigational agent within 4 weeks prior to commencing study treatment
    • Who received radiotherapy within 14 days of commencing study treatment
    • With unresolved toxicities from prior systemic therapy or radiotherapy that, in the opinion of the investigator, does not qualify the patient for study treatment
    • With medical or psychiatric conditions that compromise the patient’s ability to give informed consent or to complete the protocol
    • With prior systemic therapy, including with drugs targeting EGFR such as cetuximab, panitumumab or erlotinib
    • Pregnant or breastfeeding women
    • Severely immunocompromised patients (neutropenic as defined by < 1,500 neutrophils cells/µL; this is to optimise the safety of FMT administration)
    • With diagnosed dysphagia or other disorder affecting swallowing
    • Who received probiotic within 4 weeks of randomisation (to exclude recent manipulation of the gut microbiota)
    • Who used antibiotic within 8 weeks of randomisation (to exclude recent manipulation of the gut microbiota). Use of single dose of antibiotic during ERCP is allowed

FMT

Locations: Epworth Richmond (Richmond), Epworth Freemasons (East Melbourne), Epworth Eastern (Box Hill)

Epworth PI: A/Prof Sumitra Ananda

Jreissati Pancreatic Centre at Epworth 

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Please contact us for more information on 03 9426 8880 or email [email protected]


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