HEFTME System for Adjuvant Therapeutic Selection of Locally Advanced UTUC Postoperatively：A Perspective Cohort Study

January 22, 2025 updated by: Xuesong Li, Peking University First Hospital

Hematoxylin-eosin Staining-based Tumor Microenvironment Subtype System Adjuvant Therapeutic Selection for Locally Advanced Upper Tract Urothelial Carcinoma After Radical Surgery：A Perspective Cohort Study

This multicenter, real-world study introduces a novel Hematoxylin-eosin staining(H&E)-based four tumor microenvironment (TME) system (HEFTME system) assisting in prognostic prediction and precise adjuvant treatment selection for laUTUC postoperatively.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

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: Chunru Doc. Xu, M.D.
  • Phone Number: +86-17812172086
  • Email: xcrbdyy@126.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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Locally advanced UTUC patients such as pathological diagnosed as UTUC with muscle-invasion stages or lymph nodes metastasis.

Description

Inclusion Criteria:

  • pathological diagnose of UTUC;
  • Met more than muscle-invasion stages(pT2+) or lymph nodes metastasis.

Exclusion Criteria:

  • Patients with early-local stages (pTa/T1/Tis) without LNM+ and those with incomplete pathologic and prognostic information were excluded

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
D subtype
Participants were classified into four subtypes based on various combinations of TSR and sTIL scores: Depleted (D, TSR-low&sTIL-low)
Drug: Chemotherapy
Gemicitabin and cisplatin
F subtype
Participants were classified into four subtypes based on various combinations of TSR and sTIL scores: Fibrotic (F, TSR-high&sTIL-low)
Drug: Chemotherapy combined with immunotherapy
Chemotherapy combined with immunotherapy
IE subtpye
Participants were classified into four subtypes based on various combinations of TSR and sTIL scores: Immune Enriched, Non-Fibrotic (IE, TSR-low&sTIL-high)
Drug: Immunotherapy
PD-1/PD-L1
IE/F subtype
Participants were classified into four subtypes based on various combinations of TSR and sTIL scores: Immune Enriched and Fibrotic (IE/F, TSR-high&sTIL-high)
Drug: ADC
ADC drug like RC48

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DFS
Time Frame: 1 year, 3 years and 5 years
Disease-free survival include death and recurrence
1 year, 3 years and 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: 3 month after the start of treatment until the end of treatment
Response rate
3 month after the start of treatment until the end of treatment
OS
Time Frame: 1 year, 3 years and 5 years
Overall survival
1 year, 3 years and 5 years
AE
Time Frame: 1-3 months after starting treatment
adverse effects
1-3 months after starting treatment

Collaborators and Investigators

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

Sponsor

Peking University First Hospital

Collaborators

Peking University Third Hospital
Fujian Provincial Hospital
Sun Yat-Sen Memorial Hospital Zhongshan University

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 (Estimated)

February 1, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

December 8, 2024

First Submitted That Met QC Criteria

January 22, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 22, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSU-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://ai.yorktal.com

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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