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NCT Number: NCT06798246

HEFTME System for Adjuvant Therapeutic Selection of Locally Advanced UTUC Postoperatively：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.

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Key information

Conditions

Upper Tract Urothelial Carcinoma

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chemotherapy

Drug

Gemicitabin and cisplatin

Immunotherapy

Drug

PD-1/PD-L1

ADC

Drug

ADC drug like RC48

Chemotherapy combined with immunotherapy

Drug

Chemotherapy combined with immunotherapy

Primary outcomes

  1. DFS

    Time frame: 1 year, 3 years and 5 years

    Disease-free survival include death and recurrence

Secondary outcomes

  1. ORR

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

    Response rate

  2. OS

    Time frame: 1 year, 3 years and 5 years

    Overall survival

  3. AE

    Time frame: 1-3 months after starting treatment

    adverse effects

Study contacts

Contact information is provided by the study sponsor or research team.

Chunru Doc. Xu, M.D.

CONTACT

[email protected]

+86-17812172086

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Collaborators

  • Fujian Provincial Hospital
  • Peking University Third Hospital
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
Jan 29, 2025
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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