New combination aims to save bladders in Muscle-Invasive cancer
NCT ID NCT05531123
First seen Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time
Summary
This study tests a treatment plan for people with muscle-invasive bladder cancer who want to avoid bladder removal. Participants receive chemotherapy plus an immunotherapy drug called tislelizumab, followed by a tailored course of radiation therapy. The goal is to see if this combination can control the cancer while keeping the bladder intact.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combination of tislelizumab (an immunotherapy drug), gemcitabine and cisplatin (chemotherapy drugs), and modified hypofractionated radiation therapy
- What this could lead to
- If successful, this approach could offer a way to treat muscle-invasive bladder cancer without removing the bladder, preserving quality of life while controlling the disease.
- What could go wrong
- This is a small, early-phase trial with only 30 participants, so results may not apply to everyone. There are risks from chemotherapy, radiation, and immunotherapy, including side effects and the chance the cancer may still return.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2022
- Expected to finish
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Dec 2026
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 85 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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: * Male or female aged 18 and ≤ 85; * People who want to protect their bladder; * ECOG PS 0 2 points; * Subject underwent TURBT surgery and imaging diagnosis of musculothelial invasive bladder urothelial carcinoma (histologic variation accepted, not diffuse CIS lesion); * Accept maximum TURBT; * Clinical stages T2-4A, N0-1, M0; * Normal function of major organs (14 days prior to enrollment), i.e. meeting the following criteria: 1. Blood routine examination criteria should be met (no blood transfusion and no granulocyte colony were received within 14 days before enrollment Stimulator therapy) : HB 90 g/L or higher The ANC acuity 1.5 x 109 / L PLT acuity 100 x 109 / L 2. No functional organic disease, the following criteria should be met: T-bil ≤1.5×ULN upper limit of normal value ALT and AST≤2.5×ULN If liver metastasis, ALT and AST≤5×ULN Estimated glomerular filtration rate (EGFR 60mL /min MdRD formula) International standardized ratio (INR), activated partial thrombin time aPTT ≤1.5× ULN(this standard is only applicable to patients who did not receive anticoagulant therapy; On anticoagulant therapy Patients should keep anticoagulants within the therapeutic range) * Men who are fertile or women who are likely to become pregnant must use highly fertile men or women who are likely to become pregnant during the trial, Must be used in the testing process highly effective contraceptive methods (such as oral contraceptives, intrauterine contraceptive device, abstemious sexual desire or barrier contraception effective contraceptive methods (such as oral contraceptives, intrauterine contraceptive device, abstemious sexual desire or barrier contraceptive method combined with spermicide), and at the end of the treatment to birth control in combination with spermicide), and birth control for 12 months after the end of the treatment; * Subjects voluntarily joined the study and signed informed consent with good compliance and follow-up. The subjects voluntarily joined the study and signed informed consent with good compliance and follow-up. Exclusion Criteria: * Previously received anti-PD-1, anti-PD-L1, and anti-PD-L2 therapy; * Known to be allergic to recombinant humanized anti-PD-1 monoclonal antibody drugs and their components; * Received other antineoplastic therapy (including but not limited to corticosteroids) within 4 weeks prior to study therapy; * Alcohol therapy, immunotherapy) or other clinical studies, or have not yet recovered from the previous toxicity (except 2 degree hair loss and 1 degree neurotoxicity); * Women who are pregnant or breast-feeding, and women who wish to have children (pelvic radiation may cause ovarian function Premature aging); * HIV positive; * Patients with active hepatitis B or C; HBsAg or HBcAb positive patients were also detected with positive HBV DNA copy number (quantitative). The detection limit is 500IU/ml, or reaches the positive copy number detected by the research center); For such patients study screening must test for HBV DNA; HCV antibody test results are positive for patients, only when HCV RNA PCR test results. If it is negative, it can be included in this study; * A clear history of active tuberculosis; * Have active autoimmune diseases requiring systemic treatment within the past 2 years (e.g., using disease modulations); * Section drugs, corticosteroids, or immunosuppressive drugs), allowing for relevant alternative therapies (e.g., thyroid Hormone, insulin, or physiological corticosteroid replacement therapy for renal or pituitary insufficiency); * Other serious, uncontrolled comorbidities that may affect protocol compliance or interfere with interpretation of results; * Diseases, including active opportunistic infections or advanced (severe) infections, uncontrolled diabetes, cardiovascular disease (Defined by the New York Heart Association classification as grade ⅲ or ⅳ heart failure, grade ⅱ or higher heart, visceral block, myocardial infarction in the past 6 months, unstable arrhythmia or instability, angina pectoris, cerebral infarction within 3 months, etc.) or lung diseases (interstitial pneumonia, obstructive pulmonary disease; History of pulmonary disease and symptomatic bronchial spasm); * Received live vaccine within 4 weeks prior to the start of treatment; * Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation; * Those who have a history of abuse of psychotropic substances and cannot quit or have a history of mental disorders; Those who have a history of psychotropic drug abuse and cannot quit or have a history of mental disorders; * Large pleural or ascites with clinical symptoms or requiring symptomatic management; Large pleural or ascites with clinical symptoms or symptomatic management; * In the past five years have suffered from other malignant tumors, not cured but does not include has obvious cured malignant swell years suffered from other malignant tumors, not cured but does not include has obvious cure of malignant tumor, or can cure cancer, such as basal skin cancer or squamous cell cancer, limitations before low-risk tumor, or can be a cure for cancer, Such as basal or squamous cell skin cancer, localized low-risk prostate cancer, cervical carcinoma in situ or breast carcinoma in situ; Remarks: Localized low-risk prostate cancer (defined as adenocarcinoma, carcinoma in situ of the cervix, or carcinoma in situ of the breast; Remark: Limits (defined as low-risk prostate cancer stage for stage or less T2a, gleason score, gleason scores six points or less, and diagnosis of prostate cancer and prostate cancer diagnosis in the PSA 10 ng/mL or less (such as test (e.g., measurement) of the patients received radical amount) of the patients received radical surgery operation and without prostate specific antigen (and prostate specific antigen (P SA)) biochemical relapses biochemical relapses may participate in this study); Participants may participate in this study); * Previous history of pelvic radiation therapy; Previous history of pelvic radiation therapy; * Merged UTUC or urethral cancer * May increase risks associated with study participation, or may interfere with study participation, according to the researchers. Any other serious, acute or chronic medical or mental illness or laboratory abnormality that may increase the risk associated with study participation or that may interfere with the interpretation of study results or the interpretation of laboratory findings.
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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
-
Fudan University Shanghai Cancer Center
Shanghai, China
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Other studies related to the condition(s) this trial covers.
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