Actively Recruiting
A Study on the Accurate Evaluation of Pseudoprogression of Rectal Cancer Immunotherapy Based on Multitemporal and Multiparameter MRI
Led by Peiyi Xie · Updated on 2026-04-23
300
Participants Needed
2
Research Sites
204 weeks
Total Duration
On this page
Sponsors
P
Peiyi Xie
Lead Sponsor
X
Xinyi City People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Study on the Accurate Evaluation of Pseudoprogression of Rectal Cancer Immunotherapy Based on Multitemporal and Multiparameter MRI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Rectal cancer confirmed by biopsy pathology
- Clinical stage II-IV determined by imaging examinations
- Planned immunotherapy with PD-1/PD-L1 inhibitors alone or combined with CTLA-4 inhibitors, without prior treatments
- 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 with evaluation by iRECEST criteria or surgical pathology results
- 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
- Pathological biopsy or surgical pathology results available if imaging suggests disease progression
- Overall survival expected to be more than 3 months without other uncontrollable diseases
- Patient has provided informed consent
You will not qualify if you...
- Primary tumor surgically removed at 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
- Allergic to gadolinium contrast, contraindicated for enhanced MRI, claustrophobic, or unable to undergo MRI
- History of autoimmune diseases such as inflammatory bowel disease
- Treatment interruption due to serious complications related to immunotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Sixth affiliated hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510655
Not Yet Recruiting
2
Xinyi People's hospital
Maoming, Guangdong, China
Actively Recruiting
Research Team
P
Peiyi Xie
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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