Lab-Grown tumors may pick best drug for bladder cancer patients
NCT ID NCT07379268
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study uses lab-grown mini-tumors (organoids) from bladder cancer patients to see which anti-HER-2 drug works best. It compares survival rates of patients whose treatment is guided by these organoids versus standard protein testing. The goal is to improve one-, two-, and three-year survival for people with advanced bladder cancer who have already tried chemotherapy.
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 224 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 2028
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 with unresectable locally advanced (cT4b and/or N2-3) or metastatic bladder cancer (M1) who have failed platinum-based chemotherapy.
- 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. All bladder cancer patients to be included in the study must meet the inclusion criteria in item 3 regarding staging, and tumor biopsy tissue taken before ADC treatment will be used for organoid culture; 3. Patients with unresectable locally advanced (cT4b and/or N2-3) or metastatic bladder cancer (M1) who have failed platinum-based chemotherapy; 4. Patients who have shown disease progression after at least one round of platinum-based chemotherapy, or have no satisfactory alternative treatment options; 5. Patients who can tolerate adverse reactions from ADC drug enfortumab vedotin treatment; 6. ECOG performance status score of 0-2; 7. Judged by the investigator to be able to comply with the trial protocol, have good adherence, cooperate in monitoring adverse events and efficacy, and participate in follow-up; 8. Voluntarily participate in this clinical trial, understand the study procedures, and have signed the informed consent form for participation. Exclusion Criteria: * 1\. Patients with locally advanced or metastatic bladder cancer who have not previously received platinum-containing chemotherapy; 2. Individuals with immunodeficiency or impairment (e.g., patients with AIDS, or those using immunosuppressants or undergoing radiotherapy); 3. Participants known to be allergic to the investigational drug, similar drugs, or excipients, or those with allergic constitution; 4. Individuals on long-term steroid medication or with a history of drug abuse or dependence; 5. Those who are planning to become pregnant, are currently pregnant, or are breastfeeding; 6. Individuals with abnormal blood routine, liver and kidney function, or coagulation indicators (considered abnormal if one or more of the following are met): 1. Absolute 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) ≤ 90 g/L; 5. Total bilirubin (TBIL) ≥ 1.5 × the upper limit of normal (ULN) of the institution; 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, if considered clinically acceptable by the investigator); 7. Participants with other factors that may cause the study to be prematurely terminated, including: <!-- --> 1. History or current diagnosis of myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML); 2. History of clear neurological or psychiatric disorders, including epilepsy or dementia; 3. Severe comorbidities that endanger patient safety or affect study completion (e.g., severe hypertension, diabetes, thyroid disorders); 4. Other serious diseases requiring concomitant treatment, with severe laboratory abnormalities; 5. Other serious diseases accompanied by family or social factors that could impact participant safety, or the collection of data and samples; 6. Uncontrolled comorbid conditions, including but not limited to persistent or active infections requiring treatment, symptomatic congestive heart failure, unstable angina, or arrhythmias; 8. Participants deemed unsuitable for this study by 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, Shandong, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Dutch bladder cancer cohort aims to map survival and recurrence
- Can two drugs plus chemoradiation let bladder cancer patients keep their bladder?
- 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?