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

ConditionUpper Tract Urothelial Carcinoma
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorPeking University First Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

pathological diagnose of UTUC;

Met more than muscle-invasion stages(pT2+) or lymph nodes metastasis.

Disqualifiers

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

Trial population

Locally advanced UTUC patients such as pathological diagnosed as UTUC with muscle-invasion stages or lymph nodes metastasis.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

200 Participants
are divided into 4 treatment groups
Group A: D subtype1 intervention
Group B: F subtype1 intervention
Group C: IE subtpye1 intervention
Group D: IE/F subtype1 intervention

Trial outcomes

Primary outcomes

1

DFS

Disease-free survival include death and recurrence

Time frame
1 year, 3 years and 5 years

Secondary outcomes

1

ORR

Response rate

Time frame
3 month after the start of treatment until the end of treatment
2

OS

Overall survival

Time frame
1 year, 3 years and 5 years
3

AE

adverse effects

Time frame
1-3 months after starting treatment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University First Hospital

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Collaborator

Peking University Third Hospital

Collaborator

Fujian Provincial Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: