Predictive Cancer ModelNCT06364371
Dynamic Multi-omics Integration Model to Predict Neoadjuvant Therapy Response in Locally Advanced Rectal Cancer
An observational study of Predictive Cancer Model and Pathologic Complete Response, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
The goal of this observational study is to establish a dynamic multi-omics integration model for predicting pathological complete response (pCR) after neoadjuvant treatment in locally advanced (T3-4NxM0) rectal cancer, providing support for subsequent patient selection for the watch-and-wait strategy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Predictive Cancer Model, Pathologic Complete Response
- What is being tested?
- Medical examination
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 1 Jun 2028
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients are pathological confirmed as rectal adenocarcinoma, clinical stage T3-4NxM0, and underwent the neoadjuvant therapy before surgical treatment.
Who may be able to join
- Histologically confirmed rectal adenocarcinoma;
- Clinical stage T3-4NxM0, with or without positive Mesorectum Fascia(MRF), and with or without positive Extra-Mural Venous Invasion(EMVI);
- Preoperative staging method: All patients undergo preoperative staging with enhanced CT. Criteria for mesorectal lymph node metastasis: Short axis ≥ 10mm lymph nodes or lymph node morphology and CT characteristics consistent with typical lymph node metastasis. Preoperative chest, abdominal CT, and pelvic MRI exclude distant metastases;
- Absence of signs of intestinal obstruction; or relief of obstruction after proximal colon diversion surgery;
- No history of previous colorectal surgery;
- No history of previous chemotherapy or radiotherapy;
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- No history of previous biological therapy (such as monoclonal antibodies), immunotherapy [such as anti-programmed cell death protein 1(PD-1) antibodies, anti-PD-L1 antibodies, anti-PD-L2 antibodies, or anti-Cytotoxic T Lymphocyte-Associated Antigen-4(CTLA-4)], or other investigational drug therapy;
- No history of previous hormonal therapy: no restrictions;
- Signed informed consent form.
Who cannot join
- Patients requiring antiarrhythmic therapy (excluding β-blockers or digoxin), symptomatic coronary artery disease, recent myocardial infarction within the past 6 months, or congestive heart failure exceeding New York Heart Association(NYHA) class II;
- Poorly controlled severe hypertension;
- History of HIV infection or active chronic hepatitis B or C (high viral DNA load);
- Active pulmonary tuberculosis (TB) or receiving anti-TB treatment, or having received anti-TB treatment within the past year;
- Other active clinically severe infections ;
- Evidence of distant metastases outside the pelvis preoperatively;
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- Cachexia, organ decompensation;
- History of pelvic or abdominal radiotherapy;
- Multifocal colorectal cancer;
- Patients requiring management for epileptic seizures (e.g., with steroids or antiepileptic therapy);
- History of other malignant tumors within the past 5 years, excluding cured carcinoma in situ of the cervix or basal cell carcinoma of the skin;
- Substance abuse or medical, psychological, or social conditions that may interfere with patient participation in the study or assessment of study results;
- Presence of any active autoimmune disease or history of autoimmune disease (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, nephritis, hyperthyroidism, hypothyroidism; patients with vitiligo or childhood asthma that has completely resolved and does not require any intervention in adulthood may be included; patients with asthma requiring bronchodilators for medical intervention cannot be included);
- Vaccination with any anti-infective vaccine (e.g., influenza vaccine, varicella vaccine, etc.) within 4 weeks before enrollment;
- Complications requiring long-term use of immunosuppressive drugs or systemic or local administration of corticosteroids with immunosuppressive effects (dose > 10mg/day of prednisone or equivalent corticosteroids);
- Known or suspected allergy to the investigational drug or any medication administered related to this trial;
- Any unstable condition or situation that may jeopardize patient safety and compliance;
- Pregnancy or lactation in women of childbearing potential who have not taken adequate contraceptive measures;
- Refusal to sign the informed consent form.
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
The Sixth Affiliated Hospital, Sun Yatsen University
Guangzhou, Guangdong
Jun Huang, 13926451242, huangj97@mail.sysu.edu.cn
About this study
Official title: A Study of the Clinical Value of Dynamic Multi-omics Integration Model to Predict Neoadjuvant Therapy Response in Locally Advanced Rectal Cancer (T3-4NxM0)
The goal of this observational study is to establish a dynamic multi-omics integration model for predicting pathological complete response (pCR) after neoadjuvant treatment in locally advanced (T3-4NxM0) rectal cancer, providing support for subsequent patient selection for the watch-and-wait strategy. The main question it aims to answer is:
What is the predictive value of this model to assess individual achievement of pathological complete response (pCR) after neoadjuvant treatment? Eligible patients will be prospectively enrolled, and the clinical features of their pre-neoadjuvant treatment, during-treatment, and post-treatment preoperative will be collected and annotated.
Read the detailed description
This is a single-center, prospective, observational phase II clinical study aimed at validating a dynamic multi-omics (imaging, pathology, molecular biomarkers) integration model for predicting pathological complete response (pCR) after neoadjuvant treatment in locally advanced (T3-4NxM0) rectal cancer. Specifically, the study aims to validate the predictive accuracy of the dynamic multi-omics prediction model and determine whether it outperforms other conventional prediction models based on single-modality imaging, pathology, and molecular biomarkers.
Eligible patients will be prospectively enrolled, and images of their pre-neoadjuvant treatment, during-treatment, and post-treatment preoperative magnetic resonance imaging (MRI) scans, histopathology slides stained with hematoxylin and eosin (H\&E), carcinoembryonic antigen (CEA), and circulating tumor DNA (ctDNA) will be collected and annotated. MRI, H\&E images, CEA, ctDNA, and their change features will be applied to the prediction model to assess individual achievement of pathological complete response (pCR) after neoadjuvant treatment. The predictive results will be further compared with the pathological tumor response obtained from resected specimens.
- Being tested
- Medical examination
- Keywords
- Magnetic resonance imaging, ctDNA, Histopathology slide, CEA
- Medical subject headings
- Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical examinationOther
Eligible patients will be prospectively enrolled, and images of their pre-neoadjuvant treatment, during-treatment, and post-treatment preoperative magnetic resonance imaging (MRI) scans, histopathology slides stained with hematoxylin and eosin (H\&E), carcinoembryonic antigen (CEA), and circulating tumor DNA (ctDNA) will be collected and annotated.
| Study group | Role | What they receive |
|---|---|---|
| Observational cohort | Patients with locally advanced (T3-4NxM0) rectal adenocarcinoma Receives: Other: Medical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve(AUC)
Area under curve of prediction model
Measured: through study completion, an average of 6 months
Secondary outcomes (4)
Sensitivity
Sensitivity of prediction model
Measured: through study completion, an average of 6 months
Specificity
Specificity of prediction model
Measured: through study completion, an average of 6 months
Negative predictive value(NPV)
negative predictive value of prediction model
Measured: through study completion, an average of 6 months
Positive predictive value(PPV)
positive predictive value of prediction model
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start1 Jun 2024
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Predictive Cancer ModelStudies 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
- Prospective
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Huang, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364371
- Sponsor's protocol ID
- E2023210
- Status last verified
- Dec 2025
- First submitted
- 2 Apr 2024
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Clinical Value of Dynamic Multi-omics Integration Model to Predict Neoadjuvant Therapy Response in Locally Advanced Rectal Cancer (T3-4NxM0)
- ClinicalTrials.gov ID
- NCT06364371
- Acronym / sponsor ID
- E2023210
- Keywords
- Magnetic resonance imaging, ctDNA, Histopathology slide, CEA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 15 Apr 2024 (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.
The goal of this observational study is to establish a dynamic multi-omics integration model for predicting pathological complete response (pCR) after neoadjuvant treatment in locally advanced (T3-4NxM0) rectal cancer, providing support for subsequent patient selection for the watch-and-wait strategy. The main question it aims to answer is:
What is the predictive value of this model to assess individual achievement of pathological complete response (pCR) after neoadjuvant treatment? Eligible patients will be prospectively enrolled, and the clinical features of their pre-neoadjuvant treatment, during-treatment, and post-treatment preoperative will be collected and annotated.
Detailed description
This is a single-center, prospective, observational phase II clinical study aimed at validating a dynamic multi-omics (imaging, pathology, molecular biomarkers) integration model for predicting pathological complete response (pCR) after neoadjuvant treatment in locally advanced (T3-4NxM0) rectal cancer. Specifically, the study aims to validate the predictive accuracy of the dynamic multi-omics prediction model and determine whether it outperforms other conventional prediction models based on single-modality imaging, pathology, and molecular biomarkers.
Eligible patients will be prospectively enrolled, and images of their pre-neoadjuvant treatment, during-treatment, and post-treatment preoperative magnetic resonance imaging (MRI) scans, histopathology slides stained with hematoxylin and eosin (H\&E), carcinoembryonic antigen (CEA), and circulating tumor DNA (ctDNA) will be collected and annotated. MRI, H\&E images, CEA, ctDNA, and their change features will be applied to the prediction model to assess individual achievement of pathological complete response (pCR) after neoadjuvant treatment. The predictive results will be further compared with the pathological tumor response obtained from resected specimens.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational cohort | – | Other: Medical examinationPatients with locally advanced (T3-4NxM0) rectal adenocarcinoma |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are pathological confirmed as rectal adenocarcinoma, clinical stage T3-4NxM0, and underwent the neoadjuvant therapy before surgical treatment.
Key inclusion criteria (9 listed)
- Histologically confirmed rectal adenocarcinoma;
- Clinical stage T3-4NxM0, with or without positive Mesorectum Fascia(MRF), and with or without positive Extra-Mural Venous Invasion(EMVI);
- Preoperative staging method: All patients undergo preoperative staging with enhanced CT. Criteria for mesorectal lymph node metastasis: Short axis ≥ 10mm lymph nodes or lymph node morphology and CT characteristics consistent with typical lymph node metastasis. Preoperative chest, abdominal CT, and pelvic MRI exclude distant metastases;
- Absence of signs of intestinal obstruction; or relief of obstruction after proximal colon diversion surgery;
- No history of previous colorectal surgery;
Key exclusion criteria (19 listed)
- Patients requiring antiarrhythmic therapy (excluding β-blockers or digoxin), symptomatic coronary artery disease, recent myocardial infarction within the past 6 months, or congestive heart failure exceeding New York Heart Association(NYHA) class II;
- Poorly controlled severe hypertension;
- History of HIV infection or active chronic hepatitis B or C (high viral DNA load);
- Active pulmonary tuberculosis (TB) or receiving anti-TB treatment, or having received anti-TB treatment within the past year;
- Other active clinically severe infections ;
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 |
|---|---|---|
| Medical examinationEligible patients will be prospectively enrolled, and images of their pre-neoadjuvant treatment, during-treatment, and post-treatment preoperative magnetic resonance imaging (MRI) scans, histopathology slides stained with hematoxylin and eosin (H\&E), carcinoembryonic antigen (CEA), and circulating tumor DNA (ctDNA) will be collected and annotated. | Other | Observational cohort |
Primary outcome
Area under curve(AUC)
Time frame: through study completion, an average of 6 months
Area under curve of prediction model
4 secondary outcomes
Sensitivity
Time frame: through study completion, an average of 6 months
Specificity
Time frame: through study completion, an average of 6 months
Negative predictive value(NPV)
Time frame: through study completion, an average of 6 months
Positive predictive value(PPV)
Time frame: through study completion, an average of 6 months
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 18 Dec 2025.
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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.
Jun Huang principal investigator
Sun Yat-sen University
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 Predictive Cancer Model and Pathologic Complete Response, run by Sixth Affiliated Hospital, Sun Yat-sen 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 9 inclusion and 19 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 18 Dec 2025. 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 Jun Huang (+86-13926451242, huangj97@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under curve(AUC) (time frame: through study completion, an average of 6 months). 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 18 Dec 2025.