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New hope for bladder cancer patients: experimental drug combo aims to beat chemo

NCT ID NCT07424287

Disease control Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 21, 2026 · Updated 2 times

Summary

This Phase 3 trial is testing whether a combination of an experimental drug (SHR-1501) plus the standard immunotherapy BCG works better than chemotherapy for people with a type of bladder cancer (papillary-only NMIBC) that no longer responds to BCG alone. The study plans to enroll 236 adults who have had all visible tumors removed. The main goal is to see how long the cancer stays away. The trial is not yet recruiting.

What this could mean

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

Active substance
SHR-1501 (an experimental drug) combined with BCG (a standard immunotherapy)
What this could lead to
If successful, this combination could offer a new treatment option for people with bladder cancer that no longer responds to BCG alone, potentially delaying or avoiding the need for bladder removal.
What could go wrong
This is an early-stage Phase 3 trial, so results are not yet known. The experimental combination may not be more effective than chemotherapy, and side effects could be significant.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 236 people

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

Started

Jul 2026

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

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: 1. Aged at least 18 years, gender is not limited; 2. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2; 3. Histologic confirmation of high-risk non-muscle invasive bladder cancer (high-grade Ta and/or any T1, no carcinoma in situ); BCG-unresponsive; 4. Cystoscopy within 6 weeks before the randomization shows that the lesion has been completely removed; for T1 stage lesions, pathological results must show the presence of bladder muscle tissue; 5. Not suitable for or unwilling to undergo radical cystectomy; 6. Sufficient hematology and organ function. Exclusion Criteria: 1. Previous histopathological diagnosis was muscle-invasive, locally advanced or metastatic urothelial carcinoma (T2 or T3 or T4 or N+ or M+); 2. Received surgery such as TURBT or radiotherapy for bladder lesions within 2 weeks before the randomization; Major surgery was performed within 28 days before randomization; 3. Those who have previously received the following treatments and have not experienced disease recurrence or progression before enrolment: a) Intravesical infusion of cytotoxic chemotherapy or other drugs (such as oncolytic viruses), etc; b) Immune checkpoint inhibitors; c) Other investigatory drugs for the treatment of NMIBC; 4. Those who have previously received immunostimulant therapy; 5. Upper urinary tract tumor detected by CTU or MRU during screening period, urethral prostate tumor detected by cystoscopy, or other concomitant malignant tumors within 5 years before the first administration; 6. Previous medical history or examination suggests active tuberculosis within 1 year prior to the randomization.

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Conditions

The condition(s) this trial relates to.

bladder papillary urothelial carcinoma non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms

As listed by the trial registrant

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

NMIBC

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. 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 First Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100034, China

  • Renji Hospital Affiliated to Shanghai Jiao Tong University School

    RECRUITING

    Shanghai, Shanghai Municipality, 200120, China

More trials for these conditions

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