A Study on the Accurate Evaluation of Pseudoprogression o... | NCT07381322

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

NCT07381322

Sponsor

Peiyi Xie

Status

Recruiting

Last Update Posted

Apr 23, 2026Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Rectal Cancer

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2026Actual

Primary Completion Date

Dec 31, 2029Estimated

Completion Date

Dec 31, 2029Estimated

First Submitted Date

Jan 25, 2026

First Submission Date that Met QC Criteria

Jan 25, 2026

First Posted Date

Feb 2, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2026

Last Update Posted Date

Apr 23, 2026Actual

Name	Class
Xinyi City People's Hospital	UNKNOWN

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Label	Type	Description	Intervention Names
one group		one group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The area under curve (AUC) of receive operating characteristic (ROC) curves of models in prediction pseudoprogression after rectal cancer immunotherapy		From date of baseline MRI to date of preoperative MRI

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with rectal cancer treaded with immunotherapy

Sampling Method

Non-Probability Sample

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms