New drug cocktail shows promise for Tough-to-Treat urinary tract cancer
NCT ID NCT05837806
First seen Jun 27, 2026 · Last updated Jul 15, 2026 · Updated 2 times
Summary
This phase 2 trial is testing two drugs—tislelizumab and disitamab-vedotin—given before surgery for a rare cancer of the upper urinary tract (UTUC) that is HER2-positive and high-risk. The goal is to see if the combination can shrink or eliminate tumors, making surgery more effective. About 21 adults will receive three cycles of the drugs intravenously, then undergo standard surgery to remove the affected tissue.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tislelizumab and disitamab-vedotin
- What this could lead to
- If successful, this combination could offer a more effective and less toxic treatment option for patients with this rare cancer before surgery, potentially improving survival.
- What could go wrong
- This is a small, early-phase trial with only 21 participants, so results may not apply to everyone. The drugs can cause side effects like immune reactions or nerve damage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 21 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2022
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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). 2. Male or female aged 18 years and above; 3. Expected survival time greater than 12 weeks; 4. An ECOG status score of 0-2; 5. 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.); 6. The level of organ function 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 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. Exclusion Criteria: 1. Live attenuated vaccines, other than COVID-19 vaccine, received within 4 weeks prior to treatment or scheduled to be received during the study period 2. Active, known or suspected autoimmune disease; 3. Known history of primary immunodeficiency; 4. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation 5. Female patients who are pregnant or breastfeeding 6. 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; 7. 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 8. Known or suspected allergy history to tislelizumab and disitamab vedotin. 9. With a clear history of active tuberculosis. 10. Prior PD-1/PD-L1/CTLA-4 antibody or other immunotherapy; 11. Those who are participating in other clinical studies 12. Men of reproductive potential or women with the potential to become pregnant who are not using reliable contraception 13. 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 \[i.e., defined as greater than or equal to CTCAE grade 2 hypertension despite medication\]).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Second Hospital of Tianjin Medical University
RECRUITINGTianjin, China
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