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

NCT07381322 | Recruiting

• 1 other identifier: 2026ZSLYEC-028
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• The area under curve (AUC) of receive operating characteristic (ROC) curves of models in prediction pseudoprogression after rectal cancer immunotherapy

  From date of baseline MRI to date of preoperative MRI

Secondary Outcomes (7)

• The specificity of models in prediction pseudoprogression

  From date of baseline MRI to date of preoperative MRI

• The sensitivity of models in prediction pseudoprogression

  From date of baseline MRI to date of preoperative MRI

• The positive predictive value of models in prediction pseudoprogression

  From date of baseline MRI to date of preoperative MRI

• The negative predictive value of models in prediction pseudoprogression

  From date of baseline MRI to date of preoperative MRI

• The accuracy of models in prediction pseudoprogression

  From date of baseline MRI to date of preoperative MRI

Study Arms (1)

one group

one group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with rectal cancer treaded with immunotherapy

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peiyi Xie: lead
• Xinyi City People's Hospital: collaborator

Study Sites (2)

Sixth affiliated hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

NOT YET RECRUITING

Xinyi People's hospital

Maoming, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Peiyi Xie

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: January 25, 2026
• First Posted: February 2, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

CN (2)