Optimise viewing for

Toggle between patient and health professional views. The patient version is simplified to help people easily find suitable trials, while the professional view provides full detail.

RecruitingLast updated: 30 September 2025

FMT: This study is investigating methods to effectively treat and relieve symptoms and pain in pancreatic cancer that is unable to be removed through surgery (unresectable)Safety and efficacy of Faecal Microbiota Transplantation co-delivered with chemotherapy in improving pain, symptom management and treatment efficacy in patients with pancreatic cancer

Trial purpose

Medical clipboardCancer treatment; Side effect and wellbeing

Tumor type

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18 - 75

Trial acronym

FMT

Clinical summary

Summary

You may be eligible for this study if you are aged between 18 and 75 years of age, and have been diagnosed with non-resectable pancreatic cancer (i.e. pancreatic tumours that cannot be removed through surgery).

Eligible participants will be randomly assigned to either receive faecal microbiota transplantation (FMT) or placebo capsules in 2 separate treatment periods: one before chemotherapy and one 4 weeks after chemotherapy ends.

All participants will receive Folfirinox chemotherapy for either 3 or 6 months depending on the treating oncologist's review of their clinical response at 3 months.

Safety, tolerability and efficacy data will be collected from participants over the course of their participation in this study.

This study represents a unique opportunity to provide a new and promising intervention for the management of pancreatic cancer and its symptoms to Australian patients to improve their health outcomes.

Conditions

This trial is treating people with pancreatic cancer that is not able to be removed with surgery

Eligibility

Inclusion

Participants who will be included are patients with a pancreatic cancer diagnosis who underwent an initial CT scan, and whose tumour is not surgically resectable at first assessment (including borderline resectable). The patients must be:

• 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 Folfirinox as a chemotherapy agent
• Eastern Cooperative Oncology Group Performance status (ECOG PS) of 0-1.
• Presenting an adequate bone marrow function with haemoglobin > 100 g/L, platelets > 100 X 10^9/L neutrophils > 1.5 X 10^9/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 X upper limit of normal range (ULN) and alanine transaminase (ALT) or aspartate aminotransferase (AST)<2.5xULN (<5x ULN) if liver metastases present) within 7 days of enrolment
• Presenting a magnesium close to the lower limit of normal range within 7 days of enrolment.
• With a life expectancy of at least 12 weeks.
• Returning a negative pregnancy test around 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

Exclusion

Patients:
• Aged under 18 years old or over 75 years old at first assessment
• With resectable pancreatic tumour 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.
• Wwith 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 prebiotic or 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)
• For which the pancreatic tumour(s) were identified as a secondary cancer
• With known allergy to Creon and/ or Maxolon
• With known anaphylactic food allergy
• With a history of interstitial pneumonitis, pulmonary fibrosis or evidence of interstitial pneumonitis, or pulmonary fibrosis on baseline chest CT scan.
• With a history of Gilbert syndrome.
• With known cirrhosis, chronic active hepatitis, or chronic persistent hepatitis.
• With active bleeding diathysis.
• With uncontrolled clinically significant cardiac disease, arrhythmias or angina pectoris
• With active inflammatory bowel disease or other bowel disease causing chronic diarrhoea (defined as CTC grade 2 [CTCAE version 4.3])
• Who receive chronic treatment with immunosuppressives.
• Wth a known history of HIV seropositivity.
• Who have any severe and/or uncontrolled medical conditions or infections
• Who have a history of another primary malignant disease apart from non-melanotic skin cancer or carcinoma in situ of the uterine cervix or any other cancer treated with curative intent >2 years previously without evidence of relapse.
• Presenting brain metastasis.
• Women and partners of women of childbearing potential who are not using effective contraception. Adequate contraception must be used throughout study treatment and for 6 months following the completion of all study treatment.
• With history of serious drug adverse reactions.

Inclusion

  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

More information

Trial Identifiers

Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:

Trial sponsor

Central Adelaide Local Health Network (CALHN)

Scientific Title

Safety and efficacy of Faecal Microbiota Transplantation co-delivered with chemotherapy in improving pain, symptom management and treatment efficacy in patients with pancreatic cancer

Get Support

Peer Connect

You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.

Know more about Peer Connect

Contact cancer support

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.

Get support

Multilingual information

Learn more about clinical trials through this collection of resources in languages other than English.

View information