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A Study on the Accurate Evaluation of Pseudoprogression of Rectal Cancer Immunotherapy Based on Multitemporal and Multiparameter MRI | Clinical Trials | Clareo Health

RECRUITING

A Study on the Accurate Evaluation of Pseudoprogression of Rectal Cancer Immunotherapy Based on Multitemporal and Multiparameter MRI

NCT07381322•Peiyi Xie

View on ClinicalTrials.gov

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.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

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.

Locations (2)

Sixth affiliated hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Xinyi People's hospital

Maoming, Guangdong, China

Key Dates

Start Date

January 30, 2026

Primary Completion Date

December 31, 2029

Completion Date

December 31, 2029

Last Updated

February 6, 2026

Enrollment

300

ESTIMATED participants

Conditions

Rectal Cancer

Contacts

Peiyi Xie

CONTACT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study on the Accurate Evaluation of Pseudoprogression of Rectal Cancer Immunotherapy Based on Multitemporal and Multiparameter MRI

Inclusion Criteria

Exclusion Criteria

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