Clinical Trial on Rectal Cancer - Clinical Trials Registry

Study Overview

Status

Recruiting

Conditions

Rectal Cancer

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Peiyi Xie

Study Locations

China
- Guangdong
  - Guangzhou, Guangdong, China, 510655
    - Not yet recruiting
    - Sixth Affiliated Hospital, Sun Yat-sen University
    - Contact:
      
      Phone Number: 02038256789
      
      Email: xiepy6@mail.sysu.edu.cn
  - Maoming, Guangdong, China
    - Recruiting
    - Xinyi People's hospital
    - Contact:
      
      Xi Li Department of Radiology
      
      Phone Number: 0668-8839300
      
      Email: Lixi888@aliyun.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with rectal cancer treaded with immunotherapy

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
one group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	From date of baseline MRI to date of preoperative MRI

Secondary Outcome Measures

Outcome Measure	Time Frame
The specificity of models in prediction pseudoprogression Time Frame: From date of baseline MRI to date of preoperative MRI	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	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	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	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	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	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	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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peiyi Xie

Collaborators

Xinyi City People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

January 25, 2026

First Submitted That Met QC Criteria