New MRI method could prevent unnecessary treatment changes in rectal cancer patients
NCT ID NCT07381322
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aims to improve how doctors tell the difference between real tumor growth and pseudoprogression (a harmless, temporary increase in tumor size) after immunotherapy for rectal cancer. Researchers will use multiple MRI scans and blood tests from 300 participants to build a model that more accurately predicts pseudoprogression. The goal is to help patients avoid unnecessary changes in their cancer treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with rectal cancer treaded with immunotherapy
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Rectal cancer confirmed by biopsy pathology; 2. Clinical stage II-IV determined by imaging examinations; 3. 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; 4. Multiparametric MRI images of the rectum obtained within 2 weeks before immunotherapy, and at 6 and 12 weeks after treatment; 5. 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; 6. 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; 7. In cases where imaging suggests disease progression, pathological biopsy or surgical pathology results must be available. 8. The overall survival period is more than 3 months, and the patient does not have any other uncontrollable diseases; 9. The patient has been fully informed and has signed the informed consent form. Exclusion Criteria: 1. The primary tumor lesion has been surgically removed at the time of initial diagnosis; 2. History of other malignant tumors; 3. Unable to sign informed consent or complete the trial due to physical or psychological illness; 4. Pregnant or lactating women; 5. 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; 6. History of autoimmune diseases such as inflammatory bowel disease; 7. Treatment interruption due to serious complications related to immunotherapy.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sixth affiliated hospital, Sun Yat-sen University
NOT_YET_RECRUITINGGuangzhou, Guangdong, 510655, China
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Xinyi People's hospital
RECRUITINGMaoming, Guangdong, China
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Other studies related to the condition(s) this trial covers.
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- Can two immunotherapy drugs help rectal cancer patients skip pelvic radiation?
- Can digital surveys capture the full toll of rectal cancer treatment?
- Can a targeted drug conjugate outsmart advanced colorectal cancer?
- Can a platform trial match the right drug combo to each tumor?
- Laser light may help surgeons spot risky bowel connections