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

NCT06798246 | Not Yet Recruiting DMC

• 1 other identifier: TSU-04
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Upper Tract Urothelial Carcinoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• DFS

  Disease-free survival include death and recurrence

  1 year, 3 years and 5 years

Secondary Outcomes (3)

• ORR

  3 month after the start of treatment until the end of treatment

• OS

  1 year, 3 years and 5 years

• AE

  1-3 months after starting treatment

Study Arms (4)

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

Chemotherapy DRUG

Gemicitabin and cisplatin

D subtype

Immunotherapy DRUG

PD-1/PD-L1

IE subtpye

ADC DRUG

ADC drug like RC48

IE/F subtype

Chemotherapy combined with immunotherapy DRUG

Chemotherapy combined with immunotherapy

F subtype

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peking University First Hospital: lead
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator
• Peking University Third Hospital: collaborator
• Fujian Provincial Hospital: collaborator

MeSH Terms

Interventions

Drug Therapy; Immunotherapy

Intervention Hierarchy (Ancestors)

Therapeutics; Immunomodulation; Biological Therapy

Central Study Contacts

Chunru Doc. Xu, M.D.

CONTACT

+86-17812172086; xcrbdyy@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Urology, Peking University First Hospital

Study Record Dates

• First Submitted: December 8, 2024
• First Posted: January 29, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2030
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL