CClinicalTrials.gg
Not yet recruitingNCT06798246Updated Jan 29, 2025

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

An observational study in Upper Tract Urothelial Carcinoma, sponsored by Peking University First Hospital. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-01-29.

Sponsored by Peking University First Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Upper Tract Urothelial Carcinoma

Keywords

  • HE-stained slides
  • Tumor microenvironment
  • Precise subtype
  • Adjuvant therapy
03

In context

Carcinoma

6,738 studies on the registry are indexed under Carcinoma; 1,159 are open to participants now.

This study's planned enrollment of 200 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Peking University First Hospital is the lead sponsor of 378 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients with early-local stages (pTa/T1/Tis) without LNM+ and those with incomplete pathologic and prognostic information were excluded
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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

  • 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

  • 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

Interventions

  • DrugChemotherapy

    Gemicitabin and cisplatin

  • DrugImmunotherapy

    PD-1/PD-L1

  • DrugADC

    ADC drug like RC48

  • DrugChemotherapy combined with immunotherapy

    Chemotherapy combined with immunotherapy

06

What researchers measure

Primary outcomes

  1. DFS

    Disease-free survival include death and recurrence

    Time frame: 1 year, 3 years and 5 years

Secondary outcomes

  1. ORR

    Response rate

    Time frame: 3 month after the start of treatment until the end of treatment

  2. OS

    Overall survival

    Time frame: 1 year, 3 years and 5 years

  3. AE

    adverse effects

    Time frame: 1-3 months after starting treatment

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — http://ai.yorktal.com

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06798246
Lead sponsor
Peking University First Hospital
Collaborators
Sun Yat-Sen Memorial Hospital Zhongshan University, Peking University Third Hospital, Fujian Provincial Hospital
Responsible party
Xuesong Li (Director of Department of Urology, Peking University First Hospital, Peking University First Hospital) — Principal investigator
First posted
Jan 29, 2025
Start date
Feb 1, 2025 (estimated)
Primary completion
Jan 1, 2027 (estimated)
Completion
Jan 1, 2030 (estimated)
Last update
Jan 29, 2025

Study contacts

Chunru Doc. Xu, M.D.
Contact
xcrbdyy@126.com
+86-17812172086

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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