Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer

Condition(s) studied

Study summary

This prospective observational study characterises the tumour immune microenvironment and microbial ecology of locally advanced rectal cancer before and during neoadjuvant therapy. Tumour tissue and peripheral blood are profiled by whole-genome sequencing, single-cell RNA sequencing with paired T-cell and B-cell receptor repertoire sequencing, spatial transcriptomics of formalin-fixed paraffin-embedded sections, multiplex immunofluorescence, and blood-based proteomic, cytokine and bulk T-cell receptor analyses. The study examines how immune and stromal states change during treatment and how they relate to major pathological response.

Eligibility

Primary outcome measure(s)

• Change in immune and stromal cell composition in tumour tissue during neoadjuvant therapy — Baseline (before treatment) and week 4 after treatment initiation
  Cell-type composition and transcriptional states of T, natural killer (NK), B and myeloid populations and of stromal subsets before treatment and during neoadjuvant therapy, determined by single-cell RNA sequencing.
• Major pathological response (mPR) and its association with immune microenvironment features — Through study completion, an average of 4 years
  Proportion of patients achieving major pathological response, defined as 10% or less residual viable tumour at resection, and the association of pre-treatment and on-treatment immune microenvironment features with mPR.

Trial sites (1)

More Fujian Medical University Union Hospital trials in China

Other trials for the same condition