Rectal CancerNCT07346729
Exploring the Predictive Effect of Intestinal and Oral Microbiota on the Efficacy of Neoadjuvant Radiotherapy and Chemotherapy for Locally Advanced Rectal Cancer Based on Machine Learning
An observational study of Rectal Cancer, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
This study is a one-year, observational, prospective cohort study. For enrolled patients with newly diagnosed locally advanced rectal cancer, the treatment plan will be decided by the physician based on the 2022 NCCN Rectal Cancer Clinical Practice Guidelines in combination with the hospital's protocols. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 1 Dec 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Locally Advanced Rectal Cancer
Who may be able to join
- Voluntary signing of informed consent form
- Age range: 18-75 years old
- Diagnosed by histopathological examination and indicated by comprehensive evaluation for neoadjuvant radiotherapy and chemotherapy in locally advanced rectal cancer patients
- Immunohistochemistry or genetic testing for MSS
- Imaging shows no distant metastatic lesions
- ECOG score 0-1
- All patients are required to complete neoadjuvant concurrent chemoradiotherapy and intraoperative chemotherapy at our center, and return to the hospital on schedule for preoperative evaluation and tumor resection surgery
- After inspection and evaluation, there is normal bone marrow hematopoiesis, liver and kidney function
Who cannot join
- Previously received anti-tumor treatment
- History of other malignant tumors
- Imaging confirms the presence of distant metastases
- Patients with MSI-H or dMMR rectal cancer detected by immunohistochemistry or genetic testing
- Used probiotics, antibiotics, prebiotics, immunosuppressants, and glucocorticoids within the 4 weeks
- Pathological tissue specimens without assessable efficacy of neoadjuvant therapy
- Change treatment plan due to disease progression or severe treatment side effects
- According to the researcher's judgment, it is not suitable to participate in this study
Trial locations and contacts
1 site in 1 country.
About this study
This study is a one-year, observational, prospective cohort study. For enrolled patients with newly diagnosed locally advanced rectal cancer, the treatment plan will be decided by the physician based on the 2022 NCCN Rectal Cancer Clinical Practice Guidelines in combination with the hospital's protocols. The researchers will review the patient's medical history and laboratory reports, along with imaging examinations, to determine the patient's eligibility based on the inclusion and exclusion criteria. Before data collection, patients must sign the most recent IRB/IEC-approved informed consent form (ICF). After being diagnosed with locally advanced MSS rectal cancer, patients will provide stool and saliva samples upon admission before receiving treatment. Metagenomic sequencing will be performed to determine the abundance of gut and oral microbiota. Using these data, a predictive model will be established using machine learning methods to predict the TRG (Tumor Regression Grade) after neoadjuvant chemoradiotherapy in the enrolled patients, with internal validation conducted.
- Conditions
- Rectal Cancer
- Keywords
- Locally advanced rectal cancer, Neoadjuvant chemoradiotherapy, Metagenomic, Multi-kingdom analysis, Microbiota metabolism, Prediction model
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| responder | good response to neoadjuvant chemoradiotherapy | |
| non-responders | bad response to neoadjuvant chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Pathological Response Grading (TRG Grading)
Tumor Pathological Response Grading (TRG Grading) of Patients after Neoadjuvant Radiotherapy and Chemotherapy
Measured: an average of 3 months after neoadjuvant radiotherapy and chemotherapy
Secondary outcomes (2)
Pathological Complete Response Rate (pCR)
Measured: an average of 3 months after neoadjuvant radiotherapy and chemotherapy
Clinical Complete Response Rate (cCR)
Measured: an average of 3 months after neoadjuvant radiotherapy and chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 Jun 2023
- Primary completion1 Jun 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346729
- Sponsor's protocol ID
- NFEC-2023-219
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2026
- Last updated
- 16 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wen Y, Luo Z, Li Z, Li K, Li J, Yin S, Zou Y, Zhang H, Zhang Y, Chen K, Zhang Y, Liu S, Chen Z, Yu L, Ding Y. Oral and gut microbiota profiles in patients with locally advanced rectal cancer with varying responses to neoadjuvant chemoradiotherapy. Funct Integr Genomics. 2026 Sep 3;26(1):245. doi: 10.1007/s10142-026-02025-5.
PubMed 42690486
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Predictive Effect of Intestinal and Oral Microbiota on the Efficacy of Neoadjuvant Radiotherapy and Chemotherapy for Locally Advanced Rectal Cancer Based on Machine Learning
- ClinicalTrials.gov ID
- NCT07346729
- Acronym / sponsor ID
- NFEC-2023-219
- Conditions
- Rectal Cancer
- Keywords
- Locally advanced rectal cancer, Neoadjuvant chemoradiotherapy, Metagenomic, Multi-kingdom analysis, Microbiota metabolism, Prediction model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 16 Jan 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 is a one-year, observational, prospective cohort study. For enrolled patients with newly diagnosed locally advanced rectal cancer, the treatment plan will be decided by the physician based on the 2022 NCCN Rectal Cancer Clinical Practice Guidelines in combination with the hospital's protocols. The researchers will review the patient's medical history and laboratory reports, along with imaging examinations, to determine the patient's eligibility based on the inclusion and exclusion criteria. Before data collection, patients must sign the most recent IRB/IEC-approved informed consent form (ICF). After being diagnosed with locally advanced MSS rectal cancer, patients will provide stool and saliva samples upon admission before receiving treatment. Metagenomic sequencing will be performed to determine the abundance of gut and oral microbiota. Using these data, a predictive model will be established using machine learning methods to predict the TRG (Tumor Regression Grade) after neoadjuvant chemoradiotherapy in the enrolled patients, with internal validation conducted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| responder | – | –good response to neoadjuvant chemoradiotherapy |
| non-responders | – | –bad response to neoadjuvant chemoradiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Locally Advanced Rectal Cancer
Key inclusion criteria (8 listed)
- Voluntary signing of informed consent form
- Age range: 18-75 years old
- Diagnosed by histopathological examination and indicated by comprehensive evaluation for neoadjuvant radiotherapy and chemotherapy in locally advanced rectal cancer patients
- Immunohistochemistry or genetic testing for MSS
- Imaging shows no distant metastatic lesions
Key exclusion criteria (8 listed)
- Previously received anti-tumor treatment
- History of other malignant tumors
- Imaging confirms the presence of distant metastases
- Patients with MSI-H or dMMR rectal cancer detected by immunohistochemistry or genetic testing
- Used probiotics, antibiotics, prebiotics, immunosuppressants, and glucocorticoids within the 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tumor Pathological Response Grading (TRG Grading)
Time frame: an average of 3 months after neoadjuvant radiotherapy and chemotherapy
Tumor Pathological Response Grading (TRG Grading) of Patients after Neoadjuvant Radiotherapy and Chemotherapy
2 secondary outcomes
Pathological Complete Response Rate (pCR)
Time frame: an average of 3 months after neoadjuvant radiotherapy and chemotherapy
Clinical Complete Response Rate (cCR)
Time frame: an average of 3 months after neoadjuvant radiotherapy and chemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Derived from this study: PubMed 42690486Wen Y, Luo Z, Li Z, Li K, Li J, Yin S, Zou Y, Zhang H, Zhang Y, Chen K, Zhang Y, Liu S, Chen Z, Yu L, Ding Y. Oral and gut microbiota profiles in patients with locally advanced rectal cancer with varying responses to neoadjuvant chemoradiotherapy. Funct Integr Genomics. 2026 Sep 3;26(1):245. doi: 10.1007/s10142-026-02025-5.
- Individual participant dataSharing planned: No
Related trials for Rectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Nanfang Hospital, Southern Medical University 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 8 inclusion and 8 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: finished, as of the sponsor's last update on 16 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor Pathological Response Grading (TRG Grading) (time frame: an average of 3 months after neoadjuvant radiotherapy and chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07346729, which also lists 1 linked publication.
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 16 Jan 2026.