NCT07381322 A Study on the Accurate Evaluation of Pseudoprogression of Rectal Cancer Immunotherapy Based on Multitemporal and Multiparameter MRI
| NCT ID | NCT07381322 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peiyi Xie |
| Condition | Rectal Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2026-02-01 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2026-02-01 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Peiyi Xie
Frequently Asked Questions
Who can join the NCT07381322 clinical trial?
This trial is open to participants of all sexes, studying Rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07381322 currently recruiting?
Yes, NCT07381322 is actively recruiting participants. Visit ClinicalTrials.gov or contact Peiyi Xie to inquire about joining.
Where is the NCT07381322 trial being conducted?
This trial is being conducted at Guangzhou, China, Maoming, China.
Who is sponsoring the NCT07381322 clinical trial?
NCT07381322 is sponsored by Peiyi Xie. The trial plans to enroll 300 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.