Rectal CancerNCT07381322
A Study on the Accurate Evaluation of Pseudoprogression of Rectal Cancer Immunotherapy Based on Multitemporal and Multiparameter MRI
An observational study of Rectal Cancer, run by Peiyi Xie at 2 sites in China.
Trial summary
This project aims to use multi-temporal, multi-parameter MRI features, blood biomarkers, and clinical indicators to accurately assess pseudoprogression following immunotherapy in rectal cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rectal Cancer
- How many people
- 300 participants
- Where
- 2 sitesChina
- Study dates
- 1 Feb 2026to 31 Dec 2029
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with rectal cancer treaded with immunotherapy
Who may be able to join
- Rectal cancer confirmed by biopsy pathology;
- Clinical stage II-IV determined by imaging examinations;
- Decided by the MDT team to receive immunotherapy (monotherapy with PD-1/PD-L1 inhibitors or in combination with CTLA-4 inhibitors), without prior treatment of any other kind;
- Multiparametric MRI images of the rectum obtained within 2 weeks before immunotherapy, and at 6 and 12 weeks after treatment;
- Follow-up CT/MRI data available; evaluation conducted according to the iRECEST criteria, or surgical resection performed to obtain postoperative pathological results, which are necessary for assessing the efficacy of immunotherapy and diagnosing pseudoprogression versus true progression;
- Blood test parameters (IL-8, NLR, LDH, S100) and clinical indicators (KPS score, CEA level, T-stage) measured within 2 weeks before immunotherapy, and at 6 and 12 weeks after treatment;
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- In cases where imaging suggests disease progression, pathological biopsy or surgical pathology results must be available.
- The overall survival period is more than 3 months, and the patient does not have any other uncontrollable diseases;
- The patient has been fully informed and has signed the informed consent form.
Who cannot join
- The primary tumor lesion has been surgically removed at the time of initial diagnosis;
- History of other malignant tumors;
- Unable to sign informed consent or complete the trial due to physical or psychological illness;
- Pregnant or lactating women;
- Those who are allergic to gadolinium-containing contrast agents or contraindicated to undergo enhanced MRI examination, or those who are claustrophobic or have other contraindications to MRI examination and cannot undergo MRI examination;
- History of autoimmune diseases such as inflammatory bowel disease;
- Treatment interruption due to serious complications related to immunotherapy.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Peiyi Xie contact
China2 sites, 2 recruiting
- Not yet recruiting
Sixth affiliated hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
02038256789, xiepy6@mail.sysu.edu.cn
- Recruiting
Xinyi People's hospital
Maoming, Guangdong
Xi Li Department of Radiology, 0668-8839300, Lixi888@aliyun.com
About this study
This project aims to use multi-temporal, multi-parameter MRI features, blood biomarkers, and clinical indicators to accurately assess pseudoprogression following immunotherapy in rectal cancer.
- Conditions
- Rectal Cancer
- 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 |
|---|---|---|
| one group | one group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area under curve (AUC) of receive operating characteristic (ROC) curves of models in prediction pseudoprogression after rectal cancer immunotherapy
Measured: From date of baseline MRI to date of preoperative MRI
Secondary outcomes (7)
The specificity of models in prediction pseudoprogression
Measured: From date of baseline MRI to date of preoperative MRI
The sensitivity of models in prediction pseudoprogression
Measured: From date of baseline MRI to date of preoperative MRI
The positive predictive value of models in prediction pseudoprogression
Measured: From date of baseline MRI to date of preoperative MRI
The negative predictive value of models in prediction pseudoprogression
Measured: From date of baseline MRI to date of preoperative MRI
The accuracy of models in prediction pseudoprogression
Measured: From date of baseline MRI to date of preoperative MRI
Disease-free survival and overall survival
Measured: From date of enrollement until the date of first documented progression or date of death from any cause,whichever came first,assessed up to 60 months
patients are divided into: iCPD patients are classified as the 'tumor progression group after immunotherapy,' while iCR, iPR, and iSD patients are classified as the 'non-tumor progression group after immunotherapy.
Measured: From date of enrollement until the date of first documented progression or date of death from any cause,whichever came first,assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 Feb 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Peiyi Xie
- Sponsor type
- University, hospital or other
- Collaborators
- Xinyi City People's Hospital
- Responsible party
- Sponsor-investigator, Peiyi Xie, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381322
- Sponsor's protocol ID
- 2026ZSLYEC-028
- Status last verified
- Apr 2026
- First submitted
- 25 Jan 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Accurate Evaluation of Pseudoprogression of Rectal Cancer Immunotherapy Based on Multitemporal and Multiparameter MRI
- ClinicalTrials.gov ID
- NCT07381322
- Acronym / sponsor ID
- 2026ZSLYEC-028
- Conditions
- Rectal Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peiyi XieUniversity, hospital or other
- Collaborators
- Xinyi City People's Hospital
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 2 Feb 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 project aims to use multi-temporal, multi-parameter MRI features, blood biomarkers, and clinical indicators to accurately assess pseudoprogression following immunotherapy in rectal cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one group | – | –one group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with rectal cancer treaded with immunotherapy
Key inclusion criteria (9 listed)
- Rectal cancer confirmed by biopsy pathology;
- Clinical stage II-IV determined by imaging examinations;
- Decided by the MDT team to receive immunotherapy (monotherapy with PD-1/PD-L1 inhibitors or in combination with CTLA-4 inhibitors), without prior treatment of any other kind;
- Multiparametric MRI images of the rectum obtained within 2 weeks before immunotherapy, and at 6 and 12 weeks after treatment;
- Follow-up CT/MRI data available; evaluation conducted according to the iRECEST criteria, or surgical resection performed to obtain postoperative pathological results, which are necessary for assessing the efficacy of immunotherapy and diagnosing pseudoprogression versus true progression;
Key exclusion criteria (7 listed)
- The primary tumor lesion has been surgically removed at the time of initial diagnosis;
- History of other malignant tumors;
- Unable to sign informed consent or complete the trial due to physical or psychological illness;
- Pregnant or lactating women;
- Those who are allergic to gadolinium-containing contrast agents or contraindicated to undergo enhanced MRI examination, or those who are claustrophobic or have other contraindications to MRI examination and cannot undergo MRI examination;
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
The area under curve (AUC) of receive operating characteristic (ROC) curves of models in prediction pseudoprogression after rectal cancer immunotherapy
Time frame: From date of baseline MRI to date of preoperative MRI
7 secondary outcomes
The specificity of models in prediction pseudoprogression
Time frame: From date of baseline MRI to date of preoperative MRI
The sensitivity of models in prediction pseudoprogression
Time frame: From date of baseline MRI to date of preoperative MRI
The positive predictive value of models in prediction pseudoprogression
Time frame: From date of baseline MRI to date of preoperative MRI
The negative predictive value of models in prediction pseudoprogression
Time frame: From date of baseline MRI to date of preoperative MRI
The accuracy of models in prediction pseudoprogression
Time frame: From date of baseline MRI to date of preoperative MRI
Disease-free survival and overall survival
Time frame: From date of enrollement until the date of first documented progression or date of death from any cause,whichever came first,assessed up to 60 months
patients are divided into: iCPD patients are classified as the 'tumor progression group after immunotherapy,' while iCR, iPR, and iSD patients are classified as the 'non-tumor progression group after immunotherapy.
Time frame: From date of enrollement until the date of first documented progression or date of death from any cause,whichever came first,assessed up to 60 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 23 Apr 2026.
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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.
Peiyi Xie contact
2 sites 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 Peiyi Xie at 2 sites 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 7 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 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Peiyi Xie, or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The area under curve (AUC) of receive operating characteristic (ROC) curves of models in prediction pseudoprogression after rectal cancer immunotherapy (time frame: From date of baseline MRI to date of preoperative MRI). 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 23 Apr 2026.