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

N/ANot Yet RecruitingNCT06798246

Peking University First Hospital200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Upper Tract Urothelial Carcinoma

Interventions

ChemotherapyDRUG

Gemicitabin and cisplatin

ImmunotherapyDRUG

PD-1/PD-L1

ADCDRUG

ADC drug like RC48

Chemotherapy combined with immunotherapy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

DFS

Disease-free survival include death and recurrence

Time frame: 1 year, 3 years and 5 years

Secondary Outcomes

ORR

Response rate

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

Overall survival

Time frame: 1 year, 3 years and 5 years

adverse effects

Time frame: 1-3 months after starting treatment

Central Contacts

Chunru Doc. Xu, M.D.

CONTACT

+86-17812172086 xcrbdyy@126.com

Data from ClinicalTrials.gov

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