‘CheckPAC’ intra-tumoural microbiota analysis
Research type
Research Study
Full title
The immune implications of intra-tumoural microbiota in pancreato-biliary cancers: a translational research study using samples from the ‘CheckPAC’ phase II clinical trial.
IRAS ID
357173
Contact name
Ashray Gunjur
Contact email
Sponsor organisation
Wellcome Sanger Institute
Duration of Study in the UK
3 years, 1 months, 0 days
Research summary
Cancers that arise from the pancreas and the biliary tract have a very poor prognosis, and limited treatment options. Recently, a new form of cancer treatment called immunotherapy, which activates the immune system against the cancer, has been shown to be effective in some patients with pancreatic or bile duct cancers, but not others. We currently do not have any biomarker to predict who will benefit.
In an ongoing collaboration, the Wellcome Sanger Institute have analysed acellular stool samples from patients with bile duct cancers from the CheckPAC clinical trial, a Danish phase II clinical study of immunotherapy in patients with pancreatic and biliary tract cancers (BTCs) (clinicaltrials identifier NCT02866383). We found a striking association between stool presence of a particular bacterium, Fusobacterium animalis, and response to immunotherapy. We hypothesise that stool presence of this bacterium may be suggestive of tumour colonisation that is dampening anti-cancer immune responses.
To test this hypothesis, this project seeks to analyse tumour tissue from patients on the same locally ethically approved trial, now looking for intra-tumoural bacteria (specifically Fusobacterium species), and the tumour immune ‘signature’ measured by genomic analysis. Patient’s have already provided written informed consent for testing of these tumour samples as part of the original trial protocol.
The Wellcome Sanger Institute will receive no more than 145 tumour tissue samples for testing, which will include some imaging and histopathlology stains, nucleic acid sequencing, and if appropriate, culturing to isolate live bacteria.
We hope this work might inform strategies to reduce or minimise the effect of this negative bacteria, to improve immunotherapy response for patients with pancreatic and bile duct cancers.REC name
East Midlands - Derby Research Ethics Committee
REC reference
25/EM/0100
Date of REC Opinion
22 Apr 2025
REC opinion
Favourable Opinion