RecruitingNCT07381322
A Study on the Accurate Evaluation of Pseudoprogression of Rectal Cancer Immunotherapy Based on Multitemporal and Multiparameter MRI
Sponsor
Peiyi Xie
Enrollment
300 participants
Start Date
Jan 30, 2026
Study Type
OBSERVATIONAL
Conditions
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
Inclusion Criteria9
- 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.
Exclusion Criteria7
- 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.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07381322
Related Trials
A Study of Response to Standard Treatment Before Surgery in People With Rectal Cancer
NCT066374626 locations
Sequential TAS-OX Alternating With TAS-IRI Plus Bevacizumab for Late-Line Metastatic Colorectal Cancer
NCT058069319 locations
Resilience and Equity in Aging, Cancer, and Health (REACH)
NCT046742671 location
A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (mCRC)
NCT0701157614 locations
SIS-Reinforced vs. Conventional Anastomosis for Mid-to-Low Rectal Cancer: A Multicenter RCT on Anastomotic Leak
NCT072097871 location