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New bladder cancer cocktail aims to save the bladder

NCT ID NCT05975307

Disease control Sponsor: Sun Yat-sen University Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 2 trial is testing whether a combination of chemotherapy, an immunotherapy drug called toripalimab, and radiation can effectively treat muscle-invasive bladder cancer while allowing patients to keep their bladder. About 71 adults with this type of bladder cancer will receive the drugs first, then those who respond well will get radiation plus more immunotherapy. The main goal is to see if the cancer disappears completely after treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Toripalimab (an immunotherapy drug) combined with chemotherapy (gemcitabine and cisplatin/carboplatin) and radiotherapy
What this could lead to
If successful, this could offer a bladder-sparing treatment option for muscle-invasive bladder cancer, avoiding the need for surgical removal of the bladder.
What could go wrong
This is a small, early-phase trial with only 71 participants, so results may not apply to everyone. Combining immunotherapy with chemotherapy and radiation can cause significant side effects, and the treatment may not work for all patients.

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 71 people

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

Started

Dec 2023

Expected to finish

Dec 2029

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 75 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: * Pathologically diagnosed bladder malignant tumor via biopsy * Urothelial carcinoma as the primary histological component * Pretreatment clinical TNM stage as T2-4aN0M0 or T1-4aN1-2M0 (UICC TNM staging classification, version 8) * Age between 18 and 75 years old * Karnofsky performance score ≥ 70 * Creatinine clearance rate ≥ 30 ml/min Exclusion Criteria: * Simultaneous tumors of the urethra or upper urinary tract * Existence of small cell cancer component * Uncontrolled tuberculosis, viral hepatitis or AIDS * Autoimmune or mental diseases * Severe cardiac, renal, hepatic or hematopoietic dysfunctions unsuitable for chemotherapy, radiotherapy or immune checkpoint inhibiting therapy * Prior history of other malignancies within 5 years, except cured cervical carcinoma in situ and skin basal cell carcinoma * Prior history of pelvic radiotherapy or chemotherapy * Poor adherence to regular follow-up (cystoscopy, CT, MRI, etc.) * Pregnant or lactating women * Treatment with glucocorticoid or immunosuppressive drugs within 1 month * Other situations for which the investigators consider a patient inappropriate to participate

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Conditions

The condition(s) this trial relates to.

infiltrating bladder urothelial carcinoma Urinary Bladder Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Muscle-invasive bladder carcinoma Programmed cell death protein 1 inhibitor Radiotherapy

Contacts and locations

Locations

  • Cancer Center, Sun Yat-sen University

    Guangzhou, Guangdong, 510060, China

More trials for these conditions

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