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NCT Number: NCT07566559

Rectal Cancer Neoadjuvant Therapy-Real World Study

This study aims to utilise a real-world data platform to integrate multi-omics data-including radiomics, gut microbiota, pathological quality control and liquid biopsy-to construct a multidimensional predictive model for the efficacy of rectal cancer treatment following neoadjuvant therapy. By integrating multimodal data, the study aims to accurately assess the efficacy of neoadjuvant therapy and identify patients suitable for a 'watch-and-wait' strategy, thereby achieving tumour control and preserving organ function without the need for surgery. Furthermore, it seeks to provide scientific evidence for the efficacy of the 'watch-and-wait' strategy and the selection of optimal timing for surgery, whilst validating the model's effectiveness and assessing its clinical feasibility through prospective clinical trials.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

Location status: Recruiting

Location contact

hongwei Yao

CONTACT

[email protected]

About this study

  • Optimisation and predictive modelling of immunotherapy combined with neoadjuvant chemoradiotherapy Through real-world studies, we will evaluate the efficacy and safety of immunotherapy combined with neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer, focusing on comparing outcomes with traditional chemoradiotherapy regimens to optimise neoadjuvant treatment protocols. By integrating radiomics and molecular subtyping data, we will develop a deep learning model to predict the rate of pathological complete response, thereby accurately forecasting treatment outcomes for patients. This model can further optimise personalised treatment decisions, enhance the effectiveness of organ-preservation strategies, and ultimately reduce surgical trauma for patients.
  • A Treatment Efficacy Assessment System Combining Multi-omics Data with Artificial Intelligence Integrate multi-omics data (such as molecular subtyping, radiomics, and pathological assessment) with artificial intelligence technology to establish a treatment efficacy assessment system. Utilise deep learning models to analyse pre- and post-treatment imaging data and pathological samples, thereby achieving precise efficacy assessment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient is informed and has provided written informed consent;
  • Rectal adenocarcinoma confirmed by colonoscopic biopsy and pathology, meeting the following criteria:
  • Clinical stage II/III locally advanced rectal cancer (LARC): cT1-4aN0-2M0;
  • The distal edge of the tumor is ≤ 10 cm from the anal verge (measured by MRI);
  • No distant metastasis;
  • 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).

Treatment and study plan

This study is a multicenter, real-world, non-interventional study.

Other

non-interventional study

Primary outcomes

  1. To compare the complete response rates across different treatments.

    Time frame: Post-neoadjuvant Therapy Efficacy Assessment Time Point (within 8-12 weeks after radiotherapy completion)

    Compare the complete response rates (including pathological complete response [pCR] and clinical complete response [cCR]) between a neoadjuvant regimen combining chemoradiotherapy with immunotherapy and the traditional neoadjuvant chemoradiotherapy regimen, in patients with locally advanced rectal cancer.

Secondary outcomes

  1. Safety profile

    Time frame: 20 weeks after the first radiotherapy session

    Adverse Events (AEs): Type, incidence, severity, and relationship to the study treatment. Severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0).

  2. Therapy Tolerability

    Time frame: 20 weeks after the first radiotherapy session

    The proportions of patients with dose interruption, dose reduction, and treatment discontinuation during the neoadjuvant treatment period, all due to treatment-related toxicity.

  3. Disease-Free Survival (DFS)

    Time frame: within 5 years after completion of neoadjuvant therapy

    Disease-Free Survival (DFS) is a key endpoint (a measure of outcome) used primarily in oncology clinical trials, especially for evaluating adjuvant or curative treatments.

Other outcomes

  1. Overall Survival (OS)

    Time frame: within 5 years after completion of neoadjuvant therapy

    Overall Survival (OS) is the primary and most objective endpoint in oncology clinical trials. It measures the time from a defined starting point (e.g., date of diagnosis, randomization in a trial, or start of treatment) until death from any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

hongwei Yao, Professor, Doctoral Degree

CONTACT

[email protected]

63139203

Sponsors and collaborators

Lead sponsor

Beijing Friendship Hospital

Other

Registry information

Official study title

Establishing a Strategy for Selecting Watchful Waiting and Determining the Optimal Timing for Surgery Following Neoadjuvant Therapy

Acronym: RC-NAT-RWS

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 5, 2026
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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