Safety and efficacy of faecal transplant and chemotherapy in the management of pancreatic cancer

Exclusion Criteria31

• 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.