Summary
This consensus guideline (iRECIST) was developed by the RECIST working group to standardise tumour assessment in cancer immunotherapy trials, addressing the distinct response patterns observed with immune modulators compared to conventional chemotherapy. The guideline provides a standardised approach to solid tumour measurement and establishes consistent criteria for evaluating objective change in tumour size across immunotherapy trials. By defining required datapoints and facilitating a data warehouse for validation, iRECIST aims to enable consistent conduct, interpretation, and analysis of immunotherapy efficacy across multiple trials.
UK applicability
This guideline is applicable to UK cancer research institutions and clinical trial networks conducting immunotherapy trials, as it provides standardised measurement protocols that facilitate international trial harmonisation and data comparability. Adoption of iRECIST would support UK participation in multi-centre immunotherapy research and ensure consistency with international standards for trial conduct and reporting.
Key measures
Modified RECIST criteria for solid tumour measurements; definitions of objective response and disease progression in immunotherapy trials; minimum datapoint specifications for trial data collection and warehouse compilation
Outcomes reported
The study presents iRECIST guidelines for standardised measurement of tumour burden and assessment of objective response in cancer immunotherapy trials. It defines modified Response Evaluation Criteria in Solid Tumours (RECIST version 1.1) adapted for immunotherapeutic agents and specifies minimum datapoints required for future trial validation.
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