Upper Tract Urothelial CarcinomaNCT06798246
HEFTME System for Adjuvant Therapeutic Selection of Locally Advanced UTUC Postoperatively：A Perspective Cohort Study
An observational study of Upper Tract Urothelial Carcinoma, run by Peking University First Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Upper Tract Urothelial Carcinoma
- What is being tested?
- Chemotherapy, Immunotherapy and ADC
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 1 Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Locally advanced UTUC patients such as pathological diagnosed as UTUC with muscle-invasion stages or lymph nodes metastasis.
Who may be able to join
- pathological diagnose of UTUC;
- Met more than muscle-invasion stages(pT2+) or lymph nodes metastasis.
Who cannot join
- Patients with early-local stages (pTa/T1/Tis) without LNM+ and those with incomplete pathologic and prognostic information were excluded
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Hematoxylin-eosin Staining-based Tumor Microenvironment Subtype System Adjuvant Therapeutic Selection for Locally Advanced Upper Tract Urothelial Carcinoma After Radical Surgery：A Perspective Cohort Study
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
- Being tested
- Chemotherapy, Immunotherapy, ADC, Chemotherapy combined with immunotherapy
- Keywords
- HE-stained slides, Tumor microenvironment, Precise subtype, Adjuvant therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
Gemicitabin and cisplatin
ImmunotherapyDrug
PD-1/PD-L1
ADCDrug
ADC drug like RC48
Chemotherapy combined with immunotherapyDrug
Chemotherapy combined with immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| D subtype | Participants were classified into four subtypes based on various combinations of TSR and sTIL scores: Depleted (D, TSR-low\&sTIL-low) Receives: 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) Receives: 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) Receives: 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) Receives: Drug: ADC |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS
Disease-free survival include death and recurrence
Measured: 1 year, 3 years and 5 years
Secondary outcomes (3)
ORR
Response rate
Measured: 3 month after the start of treatment until the end of treatment
OS
Overall survival
Measured: 1 year, 3 years and 5 years
AE
adverse effects
Measured: 1-3 months after starting treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Tract Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Peking University Third Hospital, Fujian Provincial Hospital
- Responsible party
- Principal investigator, Xuesong Li, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798246
- Sponsor's protocol ID
- TSU-04
- Status last verified
- Jan 2025
- First submitted
- 8 Dec 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://ai.yorktal.com
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hematoxylin-eosin Staining-based Tumor Microenvironment Subtype System Adjuvant Therapeutic Selection for Locally Advanced Upper Tract Urothelial Carcinoma After Radical Surgery：A Perspective Cohort Study
- ClinicalTrials.gov ID
- NCT06798246
- Acronym / sponsor ID
- TSU-04
- Conditions
- Upper Tract Urothelial Carcinoma
- Keywords
- HE-stained slides, Tumor microenvironment, Precise subtype, Adjuvant therapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Peking University Third Hospital, Fujian Provincial Hospital
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| D subtype | – | Drug: ChemotherapyParticipants were classified into four subtypes based on various combinations of TSR and sTIL scores: Depleted (D, TSR-low\&sTIL-low) |
| F subtype | – | Drug: Chemotherapy combined with immunotherapyParticipants were classified into four subtypes based on various combinations of TSR and sTIL scores: Fibrotic (F, TSR-high\&sTIL-low) |
| IE subtpye | – | Drug: ImmunotherapyParticipants 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 | – | Drug: ADCParticipants were classified into four subtypes based on various combinations of TSR and sTIL scores: Immune Enriched and Fibrotic (IE/F, TSR-high\&sTIL-high) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Locally advanced UTUC patients such as pathological diagnosed as UTUC with muscle-invasion stages or lymph nodes metastasis.
Key inclusion criteria (2 listed)
- pathological diagnose of UTUC;
- Met more than muscle-invasion stages(pT2+) or lymph nodes metastasis.
Key exclusion criteria (1 listed)
- Patients with early-local stages (pTa/T1/Tis) without LNM+ and those with incomplete pathologic and prognostic information were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChemotherapyGemicitabin and cisplatin | Drug | D subtype |
| ImmunotherapyPD-1/PD-L1 | Drug | IE subtpye |
| ADCADC drug like RC48 | Drug | IE/F subtype |
| Chemotherapy combined with immunotherapyChemotherapy combined with immunotherapy | Drug | F subtype |
Primary outcome
DFS
Time frame: 1 year, 3 years and 5 years
Disease-free survival include death and recurrence
3 secondary outcomes
ORR
Time frame: 3 month after the start of treatment until the end of treatment
OS
Time frame: 1 year, 3 years and 5 years
AE
Time frame: 1-3 months after starting treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: Yes. http://ai.yorktal.com
Related trials for Upper Tract Urothelial Carcinoma
RecruitingPhase 2/3
Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer
Renal Pelvis and Ureter Urothelial Carcinoma
RecruitingPhase 2
Phase 2A/B Efficacy and Safety of Dabogratinib in Participants With Low Grade Upper Tract Urothelial Carcinoma
Low Grade Upper Tract Urothelial Carcinoma
Not yet recruitingObservational study
Circulating Tumor DNA (ctDNA) in High Grade Upper Tract Urothelial Cancer (UTUC)
Upper Tract Urothelial Carcinoma
Not yet recruitingPhase 2
Neoadjuvant Disitamab Vedotin, Toripalimab, and Radiotherapy for High-risk UTUC ( LUXUS07.1 )
Urothelial Carcinoma of the Renal Pelvis and Ureter, Neoadjuvant Therapy
Recruiting
Flexible Ureterorenoscopy for Surveillance of Upper Tract Urothelial Carcinoma
Upper Tract Urothelial Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Tract Urothelial Carcinoma, run by Peking University First Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chunru Doc. Xu, M.D. (+86-17812172086, xcrbdyy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFS (time frame: 1 year, 3 years and 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.