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New drug duo aims to shrink upper tract bladder cancer before surgery

NCT ID NCT07412171

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

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

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.

Pathologic Complete Response renal pelvis/ureter urothelial carcinoma

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.