Neoadjuvant ImmunotherapyPhase 2NCT05837806
Efficacy and Safety of Tislelizumab in Combination With Disitamab-vedotin as Neoadjuvant Therapy for HER2-positive High-risk Upper Tract Urothelial Carcinoma (UTUC)
A Phase 2 study testing tislelizumab+disitamab-vedotin in people with Neoadjuvant Immunotherapy, run by Tianjin Medical University Second Hospital at 1 site in China.
Trial summary
Neoadjuvant chemotherapy treatment can be used for specific UTUC patients, especially for highly staged and/or grade tumors, such as kidneys with potentially decreased renal function after RNU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoadjuvant Immunotherapy
- What is being tested?
- tislelizumab+disitamab-vedotin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2022to 30 Dec 2027
- 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
- Radiographically(CT, MRI or PET-CT, etc.) and histologically confirmed diagnosis of localized HER-2 expressing upper urothelial carcinoma( (cT1-4N0-2M0, HER-2 immunohistochemistry (IHC) ≥ 1+); high risk disease (according to EAU Guidelines for UTUC); planning to receive radical nephroureterectomy (RNU), distal ureterectomy (DU) or ureteroscopic ablation (UA).
- Male or female aged 18 years and above;
- Expected survival time greater than 12 weeks;
- An ECOG status score of 0-2;
- Agree to provide specimens of blood, urine, and tissue examination (for detection of MRD, PD-L1 expression, HER2 expression, tumor mutation load, immunohistochemistry, DNA and RNA detection, etc.);
- The level of organ function must meet the following requirements:
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- hematological indicators: absolute neutrophil count ≥ 1.5 × 10^9/L, platelet count ≥ 80 × 10^9/L, hemoglobin ≥ 6.0 g/dL (can be maintained by symptomatic treatment)
- hepatic function: total bilirubin ≤ 1.5 times the upper limit of normal, and glutathione and glutamic oxalacetic transaminase ≤ 2.5 times the upper limit of normal;
- renal function: GFR ≥ 15 ml/min;
- Subjects voluntarily joined the study, signed an informed consent form, were compliant, and cooperated with the follow-up.
Who cannot join
- Live attenuated vaccines, other than COVID-19 vaccine, received within 4 weeks prior to treatment or scheduled to be received during the study period
- Active, known or suspected autoimmune disease;
- Known history of primary immunodeficiency;
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
- Female patients who are pregnant or breastfeeding
- Untreated acute or chronic active hepatitis B or C infection. Patients who are receiving antiviral therapy with monitoring of viral copy number and are eligible for enrollment as determined by the physician on an individual patient basis;
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- Previous use of immunosuppressive drugs, excluding nasal spray and inhaled corticosteroids or physiologic doses of systemic steroids (i.e., no more than 10 mg/day prednisolone or equivalent pharmacologic physiologic doses of other corticosteroids), within 4 weeks prior to initiation of therapy
- Known or suspected allergy history to tislelizumab and disitamab vedotin.
- With a clear history of active tuberculosis.
- Prior PD-1/PD-L1/CTLA-4 antibody or other immunotherapy;
- Those who are participating in other clinical studies
- Men of reproductive potential or women with the potential to become pregnant who are not using reliable contraception
- Uncontrolled co-morbidities, including but not limited to
- HIV-infected individuals (HIV-positive);
- Severe infections that are active or poorly controlled clinically (including patients in the period of neocoronavirus infection)
- Evidence of the presence of severe or uncontrolled systemic disease (e.g., severe psychiatric, neurological disease, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, hepatic or renal disease, uncontrolled hypertension [i.e., defined as greater than or equal to CTCAE grade 2 hypertension despite medication]).
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
Hailong Hu, MD,PhD, +86 13662096232, hhllove2004@163.com
About this study
Official title: A Single-arm, Open Clinical Trial of Efficacy and Safety of Tislelizumab in Combination With Disitamab-vedotin as Neoadjuvant Therapy for HER2-positive High-risk Upper Tract Urothelial Carcinoma (UTUC)
Neoadjuvant chemotherapy treatment can be used for specific UTUC patients, especially for highly staged and/or grade tumors, such as kidneys with potentially decreased renal function after RNU. Neoadjuvant therapy is a series of treatments administered preoperatively for UTUC, mainly chemotherapy, and in recent years, novel therapies of immunotherapy have emerged. Since conventional cisplatin neoadjuvant regimens also require high preoperative renal function, neoadjuvant therapy regimens such as immunotherapy provide more effective and feasible treatments for patients who are intolerant to current cisplatin chemotherapy regimens. The aim of this study was to explore the efficacy and safety of the combination of disitamab vedotin, a human epidermal growth factor receptor-2 (HER-2) targeted ADC, and tislelizumab, a humanised PD-1 ICIs, as neoadjuvant treatment for non-metastatic, high-risk, HER-2 expressing UTUC. In our study, patients enrolled will receive neoadjuvant tislelizumab plus disitamab-vedotin therapy followed by radical nephroureterectomy (RNU), distal ureterectomy (DU) or ureteroscopic ablation (UA) .
- Conditions
- Neoadjuvant Immunotherapy
- Being tested
- tislelizumab+disitamab-vedotin
- Keywords
- neoadjuvant therapy, UTUC, immunotherapy, upper tract urothelial carcinoma, PD-1, ADC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tislelizumab+disitamab-vedotinDrug
Patients enrolled will receive 3 cycles of tislelizumab 200 mg in combination with disitamab-vedotin (RC48) 2.0mg/kg intravenously.
| Study group | Role | What they receive |
|---|---|---|
| tislelizumab+disitamab-vedotin | Experimental | Not described Receives: Drug: tislelizumab+disitamab-vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological complete response (pCR)
no residual tumor was detected in the specimen from RNU/DU by pathological examination
Measured: 3 months
Secondary outcomes (7)
Treatment-related adverse events
Classified in accordance with CTCAE version 5.0
Measured: From treatment initiation to the end of treatment at 90 days.
overall survival
Defined as the time from treatment initiated to death from any cause
Measured: 5 years since treatment initiation.
recurrence-free survival
defined as the time from treatment initiated to the first occurrence of tumor recurrence (including in the upper urinary tract, bladder or metastasis).
Measured: 5 years since treatment initiation.
imaging complete response
no target lesions found in imaging examination
Measured: 3 months.
imaging partial response
More than 30% decrease in sum of diameters of target lesion in imaging examination
Measured: 3 months.
imaging progressive disease
More than 20% increase in sum of diameters or appearance of new lesions in imaging examination
Measured: 3 months.
imaging stable disease
Measured: 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start30 Dec 2022
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoadjuvant ImmunotherapyStudies 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
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Second Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hailong Hu, MD,PhD, Principal investigator, Tianjin Medical University Second Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837806
- Sponsor's protocol ID
- TRUCE-UTUC01
- Status last verified
- Jul 2026
- First submitted
- 14 Apr 2023
- Last updated
- 14 Jul 2026
- 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 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open Clinical Trial of Efficacy and Safety of Tislelizumab in Combination With Disitamab-vedotin as Neoadjuvant Therapy for HER2-positive High-risk Upper Tract Urothelial Carcinoma (UTUC)
- ClinicalTrials.gov ID
- NCT05837806
- Acronym / sponsor ID
- TRUCE-UTUC01
- Conditions
- Neoadjuvant Immunotherapy
- Keywords
- neoadjuvant therapy, UTUC, immunotherapy, upper tract urothelial carcinoma, PD-1, ADC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Tianjin Medical University Second HospitalUniversity, hospital or other
- Study start
- 30 Dec 2022 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 1 May 2023 (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.
Neoadjuvant chemotherapy treatment can be used for specific UTUC patients, especially for highly staged and/or grade tumors, such as kidneys with potentially decreased renal function after RNU. Neoadjuvant therapy is a series of treatments administered preoperatively for UTUC, mainly chemotherapy, and in recent years, novel therapies of immunotherapy have emerged. Since conventional cisplatin neoadjuvant regimens also require high preoperative renal function, neoadjuvant therapy regimens such as immunotherapy provide more effective and feasible treatments for patients who are intolerant to current cisplatin chemotherapy regimens. The aim of this study was to explore the efficacy and safety of the combination of disitamab vedotin, a human epidermal growth factor receptor-2 (HER-2) targeted ADC, and tislelizumab, a humanised PD-1 ICIs, as neoadjuvant treatment for non-metastatic, high-risk, HER-2 expressing UTUC. In our study, patients enrolled will receive neoadjuvant tislelizumab plus disitamab-vedotin therapy followed by radical nephroureterectomy (RNU), distal ureterectomy (DU) or ureteroscopic ablation (UA) .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tislelizumab+disitamab-vedotin | Experimental | Drug: tislelizumab+disitamab-vedotin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Radiographically(CT, MRI or PET-CT, etc.) and histologically confirmed diagnosis of localized HER-2 expressing upper urothelial carcinoma( (cT1-4N0-2M0, HER-2 immunohistochemistry (IHC) ≥ 1+); high risk disease (according to EAU Guidelines for UTUC); planning to receive radical nephroureterectomy (RNU), distal ureterectomy (DU) or ureteroscopic ablation (UA).
- Male or female aged 18 years and above;
- Expected survival time greater than 12 weeks;
- An ECOG status score of 0-2;
- Agree to provide specimens of blood, urine, and tissue examination (for detection of MRD, PD-L1 expression, HER2 expression, tumor mutation load, immunohistochemistry, DNA and RNA detection, etc.);
Key exclusion criteria (16 listed)
- Live attenuated vaccines, other than COVID-19 vaccine, received within 4 weeks prior to treatment or scheduled to be received during the study period
- Active, known or suspected autoimmune disease;
- Known history of primary immunodeficiency;
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
- Female patients who are pregnant or breastfeeding
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 |
|---|---|---|
| tislelizumab+disitamab-vedotinPatients enrolled will receive 3 cycles of tislelizumab 200 mg in combination with disitamab-vedotin (RC48) 2.0mg/kg intravenously. | Drug | tislelizumab+disitamab-vedotin |
Primary outcome
pathological complete response (pCR)
Time frame: 3 months
no residual tumor was detected in the specimen from RNU/DU by pathological examination
7 secondary outcomes
Treatment-related adverse events
Time frame: From treatment initiation to the end of treatment at 90 days.
overall survival
Time frame: 5 years since treatment initiation.
recurrence-free survival
Time frame: 5 years since treatment initiation.
imaging complete response
Time frame: 3 months.
imaging partial response
Time frame: 3 months.
imaging progressive disease
Time frame: 3 months.
imaging stable disease
Time frame: 3 months.
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 14 Jul 2026.
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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, MD,PhD principal investigator
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 tislelizumab+disitamab-vedotin in people with Neoadjuvant Immunotherapy, 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 10 inclusion and 16 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 14 Jul 2026. 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, MD,PhD (+86 13662096232, hhllove2004@163.com), 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: 3 months). 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 14 Jul 2026.