Mini tumors in a dish could personalize bladder cancer treatment
NCT ID NCT07379281
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing a new way to choose chemotherapy for muscle-invasive bladder cancer. Doctors will grow a miniature version of a patient's tumor in the lab (called an organoid) and test different drugs on it to see which works best. Then, the patient receives the drug that killed their organoid. The study compares survival rates of patients who get this personalized approach versus those who get standard chemotherapy, aiming to see if organoid-guided treatment leads to better outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- organoid drug sensitivity testing
- What this could lead to
- If successful, this approach could personalize chemotherapy for bladder cancer, potentially improving survival rates by selecting the most effective drugs for each patient.
- What could go wrong
- This is a relatively early-stage study (254 participants) comparing a new testing method to standard care. The organoid test may not accurately predict real drug response, and results may not apply to 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.
- Participants
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About 254 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Dec 2030
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.
Who is studied
Patients who need to come to the research center for treatment of bladder cancer
- Ages
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18 to 80 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: * 1\. Age 18-80 years, any gender; 2. Patients with cT2\~4aNxM0 MIBC who need neoadjuvant chemotherapy; 3. Patients who have not previously received systemic chemotherapy; 4. Patients who can tolerate platinum-based combination neoadjuvant chemotherapy; 5. ECOG performance status of 0-2; 6. According to the investigator's judgment, able to comply with the trial protocol, have good adherence, can cooperate in monitoring adverse events and efficacy, and participate in follow-up; 7. Voluntarily participate in this clinical trial, understand the study procedures, and have signed the informed consent form for participation. Exclusion Criteria: * 1\. Patients with muscle-invasive bladder cancer (MIBC) with clinical stage T4b or distant metastasis, or the patient's physical condition is assessed to be intolerable to radical cystectomy; 2. Immunodeficiency or damage (such as AIDS patients, patients on immunosuppressants or radiotherapy); 3. Study participants who are known to be allergic or allergic to study drugs, similar drugs, excipients; 4. Those who have been taking hormonal drugs for a long time or have a history of drug abuse and dependence; 5. Those who have recently planned to become pregnant or are already pregnant or breastfeeding; 6. Abnormal blood routine, liver and kidney function and coagulation indicators: (1 or more can be considered abnormal) 1\) Neutrophil count (ANC) ≤1.5×109/L; 2) White blood cell count (WBC) ≤3.0×109/L; 3) Platelet count (PLT) ≤90×109/L; 4) Hemoglobin (HB) ≤90g/L; 5) Total bilirubin (TBIL) ≥1.5 × institutional upper limit of normal (ULN); 6) Estimated glomerular filtration rate (eGFR) ≤ 30 ml/min/1.73m²; 7) International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≥ULN (except for patients receiving anticoagulant therapy, which need to be considered clinically acceptable by the investigator); 7. Study participants have other factors that could cause forced termination of this study, such as: 7) Patients have a previous or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML); 8) Previous history of definite neurological or psychiatric disorders, including epilepsy or dementia; 9) Concomitant diseases that seriously endanger the safety of patients or affect the completion of the study (such as severe hypertension, diabetes, thyroid disease, etc.); 10) Other serious diseases require combined treatment, with serious laboratory abnormalities; 11) Other serious diseases accompanied by family or social factors that will affect the safety of research participants, or the collection of data and samples, etc.; 12) Have uncontrolled intercurrent illness, including but not limited to ongoing or active infection requiring treatment, symptomatic congestive heart failure, unstable angina pectoris, or arrhythmia; 8. Those who are not suitable to participate in this study in the opinion of the investigator.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Qilu Hospital of Shandong University
RECRUITINGJinan, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can intensified chemotherapy before surgery clear bladder tumors?
- Lab-Grown tumor organoids could pick the right bladder chemo
- Can tumor genes decide who keeps their bladder?
- Lab-Grown tumor models could match patients to the right cancer drug
- Can heated saline during bladder surgery stop tumors from coming back?
- Can a radioactive antibody light up hidden tumors on PET scans?