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

NCT ID: NCT06798246

Last Updated: 2025-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-01

Study Completion Date

2030-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Upper Tract Urothelial Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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D subtype

Participants were classified into four subtypes based on various combinations of TSR and sTIL scores: Depleted (D, TSR-low\&sTIL-low)

Chemotherapy

Intervention Type DRUG

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)

Chemotherapy combined with immunotherapy

Intervention Type DRUG

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)

Immunotherapy

Intervention Type DRUG

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)

ADC

Intervention Type DRUG

ADC drug like RC48

Interventions

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Chemotherapy

Gemicitabin and cisplatin

Intervention Type DRUG

Immunotherapy

PD-1/PD-L1

Intervention Type DRUG

ADC

ADC drug like RC48

Intervention Type DRUG

Chemotherapy combined with immunotherapy

Chemotherapy combined with immunotherapy

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Peking University Third Hospital

OTHER

Sponsor Role collaborator

Fujian Provincial Hospital

OTHER

Sponsor Role collaborator

Peking University First Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xuesong Li

Director of Department of Urology, Peking University First Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Chunru Doc. Xu, M.D.

Role: CONTACT

+86-17812172086

Other Identifiers

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TSU-04

Identifier Type: -

Identifier Source: org_study_id

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