New hope for bladder cancer patients who can't have standard chemo
NCT ID NCT04553939
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a combination of two drugs (toripalimab and gemcitabine) given before surgery to 50 people with muscle-invasive bladder cancer who cannot take the standard chemotherapy drug cisplatin. The goal was to see how many patients had their tumors shrink or disappear. The approach aims to improve outcomes for this specific group.
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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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50 people
The number who actually took part.
- Started
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Jan 2021
- Finished
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Apr 2025
- Lead sponsor
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A government agency
The lead sponsor is a government body.
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
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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: * Be willing and able to provide written informed consent for the trial. * 18-75 years of age on day of signing informed consent. * Have histologically confirmed muscle invasive disease of the urinary bladder. * Histology must be urothelial carcinoma (transitional cell carcinoma) or urothelial carcinoma with mixed histology/features. * Clinical stage II-IIIB and Have a surgical evaluation that documents the plan for multimodality therapy with a consolidative radical cystectomy. * ECOG 0-1 and good organ function. * cisplatin ineligible. Exclusion Criteria: * A non-surgical approach recommended by the treating urologist due to any reason. * Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 28 days prior to study registration. * Has a diagnosis of immunodeficiency or received systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to study registration. * Has a known additional malignancy that is progressing or required treatment ≤ 48 months of study registration. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer. * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. * Has an active autoimmune disease requiring systemic treatment. * Has known evidence of interstitial lung disease or active, non-infectious pneumonitis. * Has an active infection requiring systemic therapy. * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. * Has received prior therapy with an anti-PD-1, anti-PD-L1, antibody. * Has a known history of Human Immunodeficiency Virus. * Has known active Hepatitis B or Hepatitis C.
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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.
Contacts and locations
Locations
-
Henan Cancer Hospital
Zhengzhou, Henan, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Lab-Grown tumor organoids could pick the right bladder chemo
- Chemo combo tested as backup for bladder cancer that outsmarts First-Line therapy
- Can two drugs spare the bladder in aggressive bladder cancer?
- Chemo gel delivered directly to kidney tumors: can it help when other options run out?
- Can tumor genes decide who keeps their bladder?