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

Peking University

Status: Not yet enrolling

Conditions: Upper Tract Urothelial Carcinoma

Treatments: Drug: Immunotherapy; Drug: Chemotherapy; Drug: ADC; Drug: Chemotherapy combined with immunotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT06798246

TSU-04

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 4 patient groups

D subtype

Description:

Participants were classified into four subtypes based on various combinations of TSR and sTIL scores: Depleted (D, TSR-low\&sTIL-low)

Treatment:

Drug: Chemotherapy

F subtype

Description:

Participants were classified into four subtypes based on various combinations of TSR and sTIL scores: Fibrotic (F, TSR-high\&sTIL-low)

Treatment:

Drug: Chemotherapy combined with immunotherapy

IE subtpye

Description:

Participants were classified into four subtypes based on various combinations of TSR and sTIL scores: Immune Enriched, Non-Fibrotic (IE, TSR-low\&sTIL-high)

Treatment:

Drug: Immunotherapy

IE/F subtype

Description:

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)

Treatment:

Drug: ADC