Characterization of the tumor microenvironment in locally advanced rectal cancer before and during neoadjuvant therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational study profiles tumor tissue and blood from patients with locally advanced rectal cancer at baseline and after completion of short-course radiotherapy followed by one cycle of chemo-immunotherapy. It uses whole-genome sequencing, single-cell RNA sequencing with paired TCR and BCR analysis, and spatial transcriptomics on tissue samples, along with multiplex immunofluorescence and plasma proteomics. The goal is to understand how immune and stromal states evolve during treatment and how these changes relate to major pathological response. Archival specimens and matched controls are used for spatial analyses to contextualize findings within pretreatment and post-treatment landscapes. The principal clinical endpoint is major pathological response at resection.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 to 75 years
* Eastern Cooperative Oncology Group performance status 0-1
* Histologically confirmed rectal adenocarcinoma
* Locally advanced disease staged as cT3-T4N0 or cT2-T4N+ without distant metastasis (AJCC 8th edition)
* Lower border of the tumour within 10 cm of the anal verge
* Scheduled to receive neoadjuvant therapy followed by surgery, with tumour tissue and peripheral blood available before and during neoadjuvant therapy
* Written informed consent for fresh biopsy or surgical tissue, or a waiver granted by the institutional ethics committee for archival specimens

Exclusion Criteria:

* Insufficient tissue or nucleic acid quality for the planned profiling assays
* Incomplete clinical records precluding assessment of pathological or clinical response
* A history of other malignancy within 5 years other than adequately treated carcinoma in situ or basal cell carcinoma

Where it's running

• Fujian Medical University Union Hospital
  Fuzhou, Fujian, China Recruiting

Study contacts

• Study coordinator: Wan-cai Que
• Email: xhyyjgb@163.com
• Phone: 0086-0591-86218304

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.