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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06798246
Enrollment
200
Registered
2025-01-29
Start date
2025-02-01
Completion date
2030-01-01
Last updated
2025-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper Tract Urothelial Carcinoma

Keywords

HE-stained slides, Tumor microenvironment, Precise subtype, Adjuvant therapy

Brief summary

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.

Interventions

DRUGChemotherapy

Gemicitabin and cisplatin

DRUGImmunotherapy

PD-1/PD-L1

DRUGADC

ADC drug like RC48

Chemotherapy combined with immunotherapy

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
CollaboratorOTHER
Peking University Third Hospital
CollaboratorOTHER
Fujian Provincial Hospital
CollaboratorOTHER
Peking University First Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
DFS1 year, 3 years and 5 yearsDisease-free survival include death and recurrence

Secondary

MeasureTime frameDescription
ORR3 month after the start of treatment until the end of treatmentResponse rate
OS1 year, 3 years and 5 yearsOverall survival
AE1-3 months after starting treatmentadverse effects

Contacts

Primary ContactChunru Doc. Xu, M.D.
xcrbdyy@126.com+86-17812172086

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026