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Not yet recruiting NCT06798246

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

— Observational Upper Tract Urothelial Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Chemotherapy, Immunotherapy, ADC, Chemotherapy combined with immunotherapy.
Who it may be relevant to
Registry conditions: Upper Tract Urothelial Carcinoma. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug Chemotherapy
    Gemicitabin and cisplatin
  • Drug Immunotherapy
    PD-1/PD-L1
  • Drug ADC
    ADC drug like RC48
  • Drug Chemotherapy combined with immunotherapy
    Chemotherapy combined with immunotherapy

Primary outcome measures

  • DFS [Time frame: 1 year, 3 years and 5 years]
Secondary outcome measures (3)
  • ORR [Time frame: 3 month after the start of treatment until the end of treatment]
  • OS [Time frame: 1 year, 3 years and 5 years]
  • AE [Time frame: 1-3 months after starting treatment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06798246 · TSU-04

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗