Upper Tract Urothelial CarcinomaPhase 2NCT07126119
Neoadjuvant Tislelizumab in Combination With Nab-Paclitaxel for UTUC
A Phase 2 study testing Nab-Paclitaxel, Tislelizumab and Radical nephroureterectomy (RNU) in people with Upper Tract Urothelial Carcinoma and Neoadjuvant Therapy, run by Tianjin Medical University Second Hospital at 1 site in China.
Trial summary
This study is designed as an open-label, single-arm, single center, phase II clinical trial, aiming to evaluate the efficacy of neoadjuvant Tislelizumab combined with Nab-Paclitaxel for patients with non-metastatic upper tract urothelial carcinoma (UTC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Tract Urothelial Carcinoma, Neoadjuvant Therapy, PD-1 Inhibitor
- What is being tested?
- Nab-Paclitaxel, Tislelizumab and Radical nephroureterectomy (RNU)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 5 Jul 2025to 30 Dec 2030
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females aged no less than 18 years old;
- UTUC indicated by ureteroscopic biopsy and imageological examination (including CT, MRI, or PET-CT), without evidences of metastasis in chest CT scan and abdominal CT scan (T1-4N0-2M0); High risk disease confirmed in accordance with the EAU guidelines.
- Histologically confirmed urothelial carcinoma or urothelial carcinoma as the major pathological component >50% in the specimen from ureteroscopic biopsy;
- Suitable and planned to receive RNU.
- Expected survival time of more than 12 weeks;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2;
- 6.Agree to provide blood, urine, and tissue samples (for testing PD-L1 expression, HER-2, tumor mutation burden, etc.); 7.The organ function levels must meet the following requirements: Hematological indicators: Absolute neutrophil count ≥1.5×10^9/L, platelet count ≥80×10^9/L, hemoglobin ≥6.0 g/dL (can be maintained through symptomatic treatment); Liver function: Total bilirubin ≤1.5 times the upper limit of normal, alanine transaminase and aspartate transaminase ≤2.5 times the upper limit of normal; Renal function: Baseline ECT renography indicates a total renal glomerular filtration rate (GFR) ≥15 ml/min.
- 8.Participants are willing to join the study and be able to sign and comply the protocol.
Who cannot join
- Concurrent primary malignancies in other sites are excluded, except for those with a history of other malignancies that have been treated and are currently stable.
- Confirmed bilateral upper tract urothelial carcinoma (UTUC).
- Presence of urothelial carcinoma in bladder is excluded, except for non-muscle-invasive bladder cancer that can be completely resected via transurethral resection of bladder tumor (TURBT).
- Received a live attenuated vaccine within 4 weeks before treatment or plan to receive during the study period;
- Active, known or suspected history of autoimmune disease;
- Known history of primary immunodeficiency;
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- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
- Pregnant or breastfeeding female patients;
- Untreated acute or chronic active Hepatitis B or Hepatitis C infection. Patients receiving antiviral therapy may be eligible if viral load is under monitored, at the discretion of the physician based on the patient's individual condition;
- Receiving immunosuppressive medication within 4 weeks prior to starting treatment, except nasal, inhaled, topical steroids, or systemic corticosteroids at physiological doses (i.e., not exceeding 10 mg/day of prednisone or equivalent dose of other corticosteroids);
- Known or suspected allergy to Tislelizumab or Nab-Paclitaxel;
- Active tuberculosis;
- Previous treatment with PD-1/PD-L1/CTLA-4 immune checkpoint inhibitors or other immunotherapies;
- Participation in another clinical study;
- Fertile men or women without effective contraception;
- Uncontrolled concurrent illness, including but not limited to:
- (1)HIV infection (HIV antibodies positive); (2)Uncontrolled severe infection; (3)Uncontrolled systemic disease (such as severe psychiatric, neurological disorders, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver, or kidney disease, uncontrolled hypertension [i.e., hypertension of CTCAE grade 2 or higher despite treatment]); (4)Active hemorrhage or newly developed thrombotic disease. (5)Renal failure with CKD grade 5 and undergoing dialysis treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Hospital of Tianjin Medical University
Tianjin, Outside U.S., 300211
Hailong Hu, +86 13662096232, Huhailong@tmu.edu.cn
Huhailong@tmu.edu.cn
About this study
Official title: Neoadjuvant Tislelizumab in Combination With Nab-Paclitaxel for Upper Tract Urothelial Carcinoma: An Open-Label, Single-Center, Single-Arm, Phase II Clinical Trial (TRUCE-U02)
This study is designed as an open-label, single-arm, single center, phase II clinical trial, aiming to evaluate the efficacy of neoadjuvant Tislelizumab combined with Nab-Paclitaxel for patients with non-metastatic upper tract urothelial carcinoma (UTC). Patients enrolled will receive 2-3 cycles of Tislelizumab in combination with Nab-Paclitaxel every 3 weeks and then undergo radical nephroureterectomy (RNU). The assessment of efficacy is based on the histology of specimen from RNU, and treatment-related adverse events (TRAEs) will be recorded and evaluated according to CTCAE 5.0.
- Being tested
- Nab-Paclitaxel, Tislelizumab, Radical nephroureterectomy (RNU)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nab-PaclitaxelDrug
Nab-Paclitaxel 125mg/m^2 IV will be administered on Day 1 every 3 weeks for 2-3 cycles
TislelizumabDrug
Tislelizumab 200mg iv will be administered on Day 1 every 3 weeks for 2-3 cycles.
Radical nephroureterectomy (RNU)Procedure or surgery
Radical nephroureterectomy (RNU) will conducted after the completion of neoadjuvant therapy.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Nab-Paclitaxel 125mg/m^2 IV on day 1 in combination with Tislelizumab 200mg IV on day 1 every 3 weeks for 2-3 cycles and then followed by radical nephroureterectomy (RNU). Receives: Drug: Nab-Paclitaxel; Drug: Tislelizumab; Procedure: Radical nephroureterectomy (RNU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR)
Defined as no residual tumor in the specimen from radical nephroureterectomy (RNU).
Measured: At the time of radical nephroureterectomy (RNU) completed (within 14 weeks of the treatment initiated)
Secondary outcomes (7)
Treatment-related adverse events (TRAEs)
Defined as adverse events that related to neoadjuvant therapy, occurring from the start of treatment (C1D1) to 90 days after the completion of the last dose, including type, incidence rate, and severity grading (assessed according to the NCI-CTCAE V5.0 criteria).
Measured: From neoadjuvant treatment initiation to 90 days after the last cycle of treatment.
Pathological Downstaging (pDS)
Defined as a reduction in the pathological T stage and N stage of the radical nephroureterectomy (RNU) specimen compared to the clinical T stage and N stage assessed at baseline.
Measured: At the time of radical nephroureterectomy (RNU) completed (within 14 weeks of the treatment initiated)
Objective Response (OR)
Defined as the achievement of partial response (PR) or complete response (CR) based on RECIST 1.1 criteria, as assessed by imaging studies after neoadjuvant therapy (prior to RNU).
Measured: After completion of neoadjuvant therapy and before RNU (9 weeks).
Events-Free Survival (EFS)
Defined as the time from treatment initiated to the first occurrence of delayed surgical disease progression, local tumor recurrence (including recurrence in the upper urinary tract and bladder, excluding non-muscle-invasive bladder cancer that can be resected by TURBT), distant metastasis, or death from any cause. The study will record the 1-, 2-, and 5-year EFS rates for the target population. Kaplan-Meier methods will be used to estimate the median EFS and 95% confidence interval limits, and Kaplan-Meier curves will be constructed to provide descriptive information on EFS.
Measured: up to 5 years
Overall Survival (OS)
Defined as the time from treatment initiated to death from any cause. The study will record the 1-, 2-, and 5-year OS rates for the target population. Kaplan-Meier methods will be used to estimate the median OS and 95% confidence interval limits, and Kaplan-Meier curves will be constructed to provide descriptive information on survival.
Measured: up to 5 years
Recurrence-Free Survival (RFS)
Defined as the time from treatment initiated to the first occurrence of tumor recurrence (including recurrence in the upper urinary tract and bladder, excluding non-muscle-invasive bladder cancer that can be removed by TURBT). The study will record the 1-, 2-, and 5-year RFS rates for the target population. Kaplan-Meier methods will be used to estimate the median RFS and 95% confidence interval limits, and Kaplan-Meier curves will be constructed to provide descriptive information on RFS.
Measured: up to 5 years
Cancer-Specific Survival (CSS)
Defined as the time from enrollment to death caused by the tumor. The study will record the 1-, 2-, and 5-year CSS rates for the target population. Kaplan-Meier methods will be used to estimate the median CSS and 95% confidence interval limits, and Kaplan-Meier curves will be constructed to provide descriptive information on CSS.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start5 Jul 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 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.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Second Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hailong Hu, PhD, Study director, Tianjin Medical University Second Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126119
- Sponsor's protocol ID
- TRUCE-U02
- Status last verified
- Apr 2025
- First submitted
- 9 Aug 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Tislelizumab in Combination With Nab-Paclitaxel for Upper Tract Urothelial Carcinoma: An Open-Label, Single-Center, Single-Arm, Phase II Clinical Trial (TRUCE-U02)
- ClinicalTrials.gov ID
- NCT07126119
- Acronym / sponsor ID
- TRUCE-U02
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Tianjin Medical University Second HospitalUniversity, hospital or other
- Study start
- 5 Jul 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 17 Aug 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 study is designed as an open-label, single-arm, single center, phase II clinical trial, aiming to evaluate the efficacy of neoadjuvant Tislelizumab combined with Nab-Paclitaxel for patients with non-metastatic upper tract urothelial carcinoma (UTC). Patients enrolled will receive 2-3 cycles of Tislelizumab in combination with Nab-Paclitaxel every 3 weeks and then undergo radical nephroureterectomy (RNU). The assessment of efficacy is based on the histology of specimen from RNU, and treatment-related adverse events (TRAEs) will be recorded and evaluated according to CTCAE 5.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Nab-Paclitaxel, Drug: Tislelizumab, Procedure: Radical nephroureterectomy (RNU)Nab-Paclitaxel 125mg/m^2 IV on day 1 in combination with Tislelizumab 200mg IV on day 1 every 3 weeks for 2-3 cycles and then followed by radical nephroureterectomy (RNU). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males or females aged no less than 18 years old;
- UTUC indicated by ureteroscopic biopsy and imageological examination (including CT, MRI, or PET-CT), without evidences of metastasis in chest CT scan and abdominal CT scan (T1-4N0-2M0); High risk disease confirmed in accordance with the EAU guidelines.
- Histologically confirmed urothelial carcinoma or urothelial carcinoma as the major pathological component >50% in the specimen from ureteroscopic biopsy;
- Suitable and planned to receive RNU.
- Expected survival time of more than 12 weeks;
Key exclusion criteria (17 listed)
- Concurrent primary malignancies in other sites are excluded, except for those with a history of other malignancies that have been treated and are currently stable.
- Confirmed bilateral upper tract urothelial carcinoma (UTUC).
- Presence of urothelial carcinoma in bladder is excluded, except for non-muscle-invasive bladder cancer that can be completely resected via transurethral resection of bladder tumor (TURBT).
- Received a live attenuated vaccine within 4 weeks before treatment or plan to receive during the study period;
- Active, known or suspected history of autoimmune disease;
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 |
|---|---|---|
| Nab-PaclitaxelNab-Paclitaxel 125mg/m^2 IV will be administered on Day 1 every 3 weeks for 2-3 cycles | Drug | Arm 1 |
| TislelizumabTislelizumab 200mg iv will be administered on Day 1 every 3 weeks for 2-3 cycles. | Drug | Arm 1 |
| Radical nephroureterectomy (RNU)Radical nephroureterectomy (RNU) will conducted after the completion of neoadjuvant therapy. | Procedure or surgery | Arm 1 |
Primary outcome
Pathological Complete Response (pCR)
Time frame: At the time of radical nephroureterectomy (RNU) completed (within 14 weeks of the treatment initiated)
Defined as no residual tumor in the specimen from radical nephroureterectomy (RNU).
7 secondary outcomes
Treatment-related adverse events (TRAEs)
Time frame: From neoadjuvant treatment initiation to 90 days after the last cycle of treatment.
Pathological Downstaging (pDS)
Time frame: At the time of radical nephroureterectomy (RNU) completed (within 14 weeks of the treatment initiated)
Objective Response (OR)
Time frame: After completion of neoadjuvant therapy and before RNU (9 weeks).
Events-Free Survival (EFS)
Time frame: up to 5 years
Overall Survival (OS)
Time frame: up to 5 years
Recurrence-Free Survival (RFS)
Time frame: up to 5 years
Cancer-Specific Survival (CSS)
Time frame: up to 5 years
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 17 Aug 2025.
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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.
Hailong Hu, PhD study director
Tianjin Medical University Second Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nab-Paclitaxel, Tislelizumab and Radical nephroureterectomy (RNU) in people with Upper Tract Urothelial Carcinoma and Neoadjuvant Therapy, run by Tianjin Medical University Second Hospital at 1 site in China.
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 8 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Hailong Hu (+86 13662096232, Huhailong@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) (time frame: At the time of radical nephroureterectomy (RNU) completed (within 14 weeks of the treatment initiated)). 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 17 Aug 2025.