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Lab-Grown tumors could personalize bladder cancer chemo
NCT ID NCT07379255
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether growing a patient's tumor cells in the lab (organoids) can help doctors choose the most effective chemotherapy after bladder cancer surgery. Researchers will compare survival rates of patients whose chemo was guided by organoid tests versus standard care. The goal is to improve outcomes for people with muscle-invasive bladder cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- organoid-guided chemotherapy selection
- What this could lead to
- If successful, this could make chemotherapy more personalized and effective for bladder cancer patients, potentially improving survival rates.
- What could go wrong
- This is an early-stage study with 266 participants, so results may not apply to everyone. Organoid testing is complex and may not always predict real patient outcomes.
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 266 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 between 18 and 80 years, any gender; 2. For patients undergoing radical cystectomy, if the pathology meets inclusion criterion No. 3, tissue from the surgical specimen will be used for organoid culture; 3. Patients with pT3-pT4 and/or lymph node-positive MIBC who require adjuvant chemotherapy after surgery; 4. Patients who can tolerate platinum-based chemotherapy; 5. ECOG performance status of 0-2; 6. According to the investigator's judgment, able to comply with the study protocol, demonstrate good adherence, cooperate with the monitoring of adverse events and efficacy, and comply with follow-up; 7. Willing to voluntarily participate in this clinical trial, understand the study procedures, and have signed the informed consent form to participate in this study. Exclusion Criteria: * 1\. Severe, life-threatening complications occurring after radical cystectomy, such as cardiovascular complications, renal failure, respiratory failure, liver failure, sepsis, pulmonary embolism, and major hemorrhage; 2. Individuals with immunodeficiency or impairment (e.g., patients with AIDS, or those receiving immunosuppressants or radiotherapy); 3. Participants known to be allergic to the study drug, similar drugs, or excipients, or those with an allergic constitution; 4. Individuals taking long-term corticosteroids or with a history of drug abuse or dependence; 5. Individuals planning pregnancy soon, currently pregnant, or breastfeeding; 6. Abnormal blood routine, liver and kidney function, and coagulation indices (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 × upper limit of normal (ULN) for 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 (excluding patients on anticoagulant therapy, if considered clinically acceptable by the investigator); 7. Other factors that may cause the study to be prematurely terminated, such as: <!-- --> 1. Patients with a past or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML); 2. A history of clear neurological or psychiatric disorders, including epilepsy or dementia; 3. Comorbidities that pose a serious risk to patient safety or could affect study completion (e.g., severe hypertension, diabetes, thyroid disorders, etc.); 4. Other serious diseases requiring combined treatment or with severe laboratory abnormalities; 5. Other serious diseases accompanied by familial or social factors that could affect participant safety, or the collection of data and samples; 6. Uncontrolled comorbid conditions, including but not limited to ongoing or active infections requiring treatment, symptomatic congestive heart failure, unstable angina, or arrhythmias; 8. Individuals deemed by the investigator as unsuitable to participate in the study.
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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.
- 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?