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

Not yet recruiting

• Conditions: Upper Tract Urothelial Carcinoma
• Interventions: Drug: Chemotherapy; Drug: Chemotherapy combined with immunotherapy; Drug: Immunotherapy; Drug: ADC

• Registration Number: NCT06798246
• Lead Sponsor: Peking University First Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-08
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-22
• Last Update Submitted: 2025-01-22
• Study First Posted: 2025-01-29
• Last Update Posted: 2025-01-29
• Study Start: 2025-02-01
• Primary Completion: 2027-01-01
• Study Completion: 2030-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
D subtype	Chemotherapy	Participants were classified into four subtypes based on various combinations of TSR and sTIL scores: Depleted (D, TSR-low\&sTIL-low)
F subtype	Chemotherapy combined with immunotherapy	Participants were classified into four subtypes based on various combinations of TSR and sTIL scores: Fibrotic (F, TSR-high\&sTIL-low)
IE subtpye	Immunotherapy	Participants were classified into four subtypes based on various combinations of TSR and sTIL scores: Immune Enriched, Non-Fibrotic (IE, TSR-low\&sTIL-high)
IE/F subtype	ADC	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)

Primary Outcome Measures

Name	Time	Method
DFS	1 year, 3 years and 5 years	Disease-free survival include death and recurrence

Secondary Outcome Measures

Name	Time	Method
ORR	3 month after the start of treatment until the end of treatment	Response rate
OS	1 year, 3 years and 5 years	Overall survival
AE	1-3 months after starting treatment	adverse effects