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Recruiting NCT07381322

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

— Observational Rectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Rectal Cancer. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • The area under curve (AUC) of receive operating characteristic (ROC) curves of models in prediction pseudoprogression after rectal cancer immunotherapy [Time frame: From date of baseline MRI to date of preoperative MRI]
Secondary outcome measures (7)
  • The specificity of models in prediction pseudoprogression [Time frame: From date of baseline MRI to date of preoperative MRI]
  • The sensitivity of models in prediction pseudoprogression [Time frame: From date of baseline MRI to date of preoperative MRI]
  • The positive predictive value of models in prediction pseudoprogression [Time frame: From date of baseline MRI to date of preoperative MRI]
  • The negative predictive value of models in prediction pseudoprogression [Time frame: From date of baseline MRI to date of preoperative MRI]
  • The accuracy of models in prediction pseudoprogression [Time frame: From date of baseline MRI to date of preoperative MRI]
  • Disease-free survival and overall survival [Time frame: From date of enrollement until the date of first documented progression or date of death from any cause,whichever came first,assessed up to 60 months]
  • patients are divided into: iCPD patients are classified as the 'tumor progression group after immunotherapy,' while iCR, iPR, and iSD patients are classified as the 'non-tumor progression group after immunotherapy. [Time frame: From date of enrollement until the date of first documented progression or date of death from any cause,whichever came first,assessed up to 60 months]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 2 centers
  • Sixth affiliated hospital, Sun Yat-sen University — Guangzhou
  • Xinyi People's hospital — Maoming

Identifiers

NCT: NCT07381322 · 2026ZSLYEC-028

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗