New drug duo aims to shrink upper tract bladder cancer before surgery
NCT ID NCT07412171
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving two drugs (toripalimab and 9MW2821) before surgery can improve outcomes for people with localized upper tract urothelial carcinoma, a type of cancer in the kidney or ureter. About 40 adults will be randomly assigned to either the drug combo followed by surgery, or surgery alone. The main goal is to see if the drugs can make the cancer disappear completely by the time of surgery.
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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 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
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 to 80 years
- 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: * Adults aged 18 to 80 years, male or female. * Histologically confirmed upper tract urothelial carcinoma (UTUC) involving the renal pelvis and/or ureter, with predominant (≥50%) urothelial histology. * Treatment-naïve, non-metastatic disease (M0) with clinical stage T1-T3, as determined by imaging. * Eligible for and willing to undergo radical nephroureterectomy with or without lymph node dissection. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate hematologic, hepatic, renal, and cardiac function as defined by the protocol. * Availability of tumor tissue for biomarker analyses. * Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: * Prior systemic anti-tumor therapy for urothelial carcinoma, except for intravesical therapy for non-muscle-invasive disease. * Prior treatment with a programmed cell death 1 (PD-1) inhibitor, programmed cell death ligand 1 or 2 (PD-L1/L2) inhibitor, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor, or antibody-drug conjugate. * Evidence of metastatic disease (M1) or regional lymph node involvement of N2 or higher. * Prior systemic anticancer therapy, including investigational agents, within 3 years prior to study enrollment. * Prior radiotherapy to the bladder or upper urinary tract. * Active autoimmune disease requiring systemic treatment. * Active or uncontrolled infection, including known active hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) infection, or active tuberculosis. * Receipt of a live or live-attenuated vaccine within 30 days prior to the first dose of study treatment. * History of allogeneic tissue or solid organ transplantation. * Uncontrolled diabetes mellitus, defined as hemoglobin A1c ≥8%, or hemoglobin A1c ≥7% to \<8% with associated diabetes-related symptoms. * Clinically significant cardiovascular disease or thromboembolic events that, in the investigator's judgment, would increase study risk. * Ongoing peripheral sensory or motor neuropathy of Grade 2 or higher. * Known psychiatric disorder or substance abuse that would interfere with study participation or compliance. * Pregnancy or breastfeeding. * Any other condition that, in the investigator's judgment, would make the participant unsuitable for the study.
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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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Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
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Other studies related to the condition(s) this trial covers.
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