Assessing early response to Immunotherapy in Head & Neck Cancer
Research type
Research Study
Full title
Immunotherapy in the treatment of recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) - Assessing early indicators of treatment response with diffusion weighted magnetic resonance imaging and the microbiome.
IRAS ID
243393
Contact name
Andrew Schache
Contact email
Sponsor organisation
The Clatterbridge Cancer Centre
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Immunotherapy, which harnesses the body’s immune system to destroy cancer cells has transformed the treatment of cancer patients across many tumour sites, including in head and neck (HNSCC) where it has become the standard of care in the recurrent/metastatic setting.
In the palliative setting only around 20% show a clinical response to immunotherapy and so it is vitally important to discover which patients are likely to respond and also how to avoid exposing patients to treatment when there may be little benefit.
We wish to assess if response to immunotherapy in HNSCC patients receiving immunotherapy as part of their standard treatment is detectable through a) changes seen in scans of patient and b) changes in the normal bacteria living in patients mouths and gut (oral/faecal microbiome).
Eligible patients will be asked to undergo extra scans during the course of their cancer care; prior to commencing immunotherapy, within 3-4 weeks of their first dose. Recruitment will be conducted at Liverpool University Hospitals Foundation NHS Trust (Aintree Hospital site) only, with scans undertaken at the Walton Centre (on the Aintree Hospital site). In parallel, patients will be asked to provide saliva and stool samples at the same time points in order to aid understanding of the relationship between tumour and host immune profile and response prediction. To gain a complete picture we would, were possible collate our additional imaging sequences and microbiome bioresource with blood and tissue samples obtained on the recently approved, Liverpool led Tissue analysis for understanding head and neck diseases study (IRAS ref number 289677). Doing so, in those individuals who have agreed to participate in both studies we may obtain comprehensive and holistic information addressing questions surrounding the complex interplay between tumour and host immune environment, microorganisms and imaging biomarkers.REC name
South Central - Berkshire Research Ethics Committee
REC reference
21/SC/0074
Date of REC Opinion
29 Mar 2021
REC opinion
Further Information Favourable Opinion