Rectal CancerRC-NAT-RWSNCT07566559
Rectal Cancer Neoadjuvant Therapy-Real World Study
An observational study of Rectal Cancer, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- This study is a multicenter, real-world, non-interventional study.
- How many people
- 869 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Dec 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with rectal cancer undergoing neoadjuvant therapy.
Who may be able to join
- 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。
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050
hongwei Yao, yaohongwei@ccmu.edu.cn
About this study
Official title: Establishing a Strategy for Selecting Watchful Waiting and Determining the Optimal Timing for Surgery Following Neoadjuvant Therapy
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.
Read the detailed description
- 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.
- Conditions
- Rectal Cancer
- Being tested
- This study is a multicenter, real-world, non-interventional study.
- Keywords
- Rectal cancer, Real world study, Neoadjuvant Therapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This study is a multicenter, real-world, non-interventional study.Other
non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Therapy Cohort for Rectal Cancer | This study is a multicentre, real-world evidence (RWE) study designed to evaluate clinical treatment regimens that offer greater benefits to patients. It will provide evidence-based guidance for clinicians in China regarding the selection of comprehensive treatment regimens for patients with advanced rectal cancer, thereby further refining and optimising clinical practice guidelines for the diagnosis and treatment of rectal cancer; it will also explore new treatment strategies for patients with locally advanced rectal cancer in the era of immunotherapy. Study design: A combination of prospective observational and retrospective cohort studies. The primary endpoint is the complete response rate (pathological complete response and clinical complete response). Receives: Other: This study is a multicenter, real-world, non-interventional study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the complete response rates across different treatments.
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.
Measured: Post-neoadjuvant Therapy Efficacy Assessment Time Point (within 8-12 weeks after radiotherapy completion)
Secondary outcomes (3)
Safety profile
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).
Measured: 20 weeks after the first radiotherapy session
Therapy Tolerability
The proportions of patients with dose interruption, dose reduction, and treatment discontinuation during the neoadjuvant treatment period, all due to treatment-related toxicity.
Measured: 20 weeks after the first radiotherapy session
Disease-Free Survival (DFS)
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.
Measured: within 5 years after completion of neoadjuvant therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start1 Jan 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 869 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yao Hongwei, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07566559
- Sponsor's protocol ID
- MR-11-26-025202
- Other IDs
- MR-11-26-025202
- Acronym
- RC-NAT-RWS
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing a Strategy for Selecting Watchful Waiting and Determining the Optimal Timing for Surgery Following Neoadjuvant Therapy
- ClinicalTrials.gov ID
- NCT07566559
- Acronym / sponsor ID
- RC-NAT-RWS / MR-11-26-025202
- Conditions
- Rectal Cancer
- Keywords
- Rectal cancer, Real world study, Neoadjuvant Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 869 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Therapy Cohort for Rectal Cancer | – | Other: This study is a multicenter, real-world, non-interventional study.This study is a multicentre, real-world evidence (RWE) study designed to evaluate clinical treatment regimens that offer greater benefits to patients. It will provide evidence-based guidance for clinicians in China regarding the selection of comprehensive treatment regimens for patients with advanced rectal cancer, thereby further refining and optimising clinical practice guidelines for the diagnosis and treatment of rectal cancer; it will also explore new treatment strategies for patients with locally advanced rectal cancer in the era of immunotherapy. Study design: A combination of prospective observational and retrospective cohort studies. The primary endpoint is the complete response rate (pathological complete response and clinical complete response). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with rectal cancer undergoing neoadjuvant therapy.
Key inclusion criteria (7 listed)
- The patient is informed and has provided written informed consent;
- Rectal adenocarcinoma confirmed by colonoscopic biopsy and pathology, meeting the following criteria:
- Age ≥ 18 years, male or female。
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This study is a multicenter, real-world, non-interventional study.non-interventional study | Other | Neoadjuvant Therapy Cohort for Rectal Cancer |
Primary outcome
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.
3 secondary outcomes
Safety profile
Time frame: 20 weeks after the first radiotherapy session
Therapy Tolerability
Time frame: 20 weeks after the first radiotherapy session
Disease-Free Survival (DFS)
Time frame: within 5 years after completion of neoadjuvant therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by Beijing Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact hongwei Yao, Professor, Doctoral Degree (63139203, yaohongwei@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.