Predicting response to neoadjuvant therapy in rectal cancer with multi-omics and AI

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 multicenter real-world observational project will integrate radiomics, gut microbiota profiling, pathological quality control, and liquid biopsy data to build a deep-learning model that predicts response to neoadjuvant therapy in rectal cancer. The study will analyse pre- and post-treatment imaging and molecular data to train and validate a multidimensional predictive system and to identify patients who might safely follow a 'watch-and-wait' approach instead of immediate surgery. It will also document outcomes of immunotherapy combined with neoadjuvant chemoradiotherapy versus traditional regimens in routine practice to inform protocol optimization. Model performance and clinical feasibility are planned to be validated through subsequent prospective clinical trials.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* The patient is informed and has provided written informed consent;
* Rectal adenocarcinoma confirmed by colonoscopic biopsy and pathology, meeting the following criteria:

  1. Clinical stage II/III locally advanced rectal cancer (LARC): cT1-4aN0-2M0;
  2. The distal edge of the tumor is ≤ 10 cm from the anal verge (measured by MRI);
  3. No distant metastasis;
  4. Scheduled to receive neoadjuvant therapy;
* Age ≥ 18 years, male or female。

Exclusion Criteria:

* Presence of distant organ metastasis;
* Multiple primary colorectal cancers;
* History of prior malignancy (except completely cured carcinoma in situ of the cervix, basal cell carcinoma, or squamous cell carcinoma of the skin).

Where it's running

• Beijing Friendship Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: hongwei Yao, Professor, Doctoral Degree
• Email: yaohongwei@ccmu.edu.cn
• Phone: 63139203

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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.