Evaluation of Postoperative Adjuvant Chemotherapy Efficacy for Bladder Cancer Based on Organoid Technology.

NCT07379255 | Recruiting DMC

• 1 other identifier: KYLL-202411-008-2
• Study Type: observational
• Target: 266
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the clinical efficacy of using tumor organoid drug sensitivity experiments to guide postoperative adjuvant chemotherapy in patients with muscle-invasive bladder cancer, and to assess the application value of tumor organoid drug sensitivity experiments in guiding individualized postoperative adjuvant chemotherapy for muscle-invasive bladder cancer.

Conditions

Bladder Cancer

Keywords

Organoid; Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• One-year OS ,Three-year OS and five-year OS

  One-year overall survival rate, three-year overall survival rate, five-year overall survival rate.

  2026.01.01-2030.12.31

Secondary Outcomes (1)

• One-year PFS ,Three-year PFS and five-year PFS

  2026.01.01-2030.12.31

Study Arms (2)

Experimental group

Using tumor organoid drug sensitivity experiments to test the sensitivity of a patient's tumor cells to seven chemotherapy drugs and formulate a postoperative adjuvant chemotherapy plan.

Other: Organoid culture

Control group

Select bladder cancer patients who underwent surgery during the same period and received postoperative adjuvant chemotherapy according to the empirical regimen as the control group.

Interventions

Organoid culture OTHER

Organoid culture of tumor tissue obtained during patient surgery

Experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who need to come to the research center for treatment of bladder cancer.

You may not qualify if:

• \. 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):
• Absolute neutrophil count (ANC) ≤ 1.5 × 10⁹/L;
• White blood cell count (WBC) ≤ 3.0 × 10⁹/L;
• Platelet count (PLT) ≤ 90 × 10⁹/L;
• Hemoglobin (HB) ≤ 90 g/L;
• Total bilirubin (TBIL) ≥ 1.5 × upper limit of normal (ULN) for the institution;
• Estimated glomerular filtration rate (eGFR) ≤ 30 ml/min/1.73m²;
• 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:
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• Patients with a past or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML);
• A history of clear neurological or psychiatric disorders, including epilepsy or dementia;
• Comorbidities that pose a serious risk to patient safety or could affect study completion (e.g., severe hypertension, diabetes, thyroid disorders, etc.);
• Other serious diseases requiring combined treatment or with severe laboratory abnormalities;
• Other serious diseases accompanied by familial or social factors that could affect participant safety, or the collection of data and samples;
• 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.

Sponsors & Collaborators

• The Second Hospital of Shandong University: collaborator
• Qianfoshan Hospital: collaborator
• Shandong Provincial Hospital: collaborator
• Shandong Province Third hospital: collaborator
• Taian City Central Hospital: collaborator
• Weifang People's Hospital: collaborator
• Binzhou Medical University: collaborator
• The Affiliated Hospital of Qingdao University: collaborator
• Jining First People's Hospital: collaborator
• Liaocheng People's Hospital: collaborator
• Linyi People's Hospital: collaborator
• Yantai Yuhuangding Hospital: collaborator
• Zibo Central Hospital: collaborator
• Dezhou Hospital Qilu Hospital of Shandong University: collaborator
• Zaozhuang Municipal Hospital: collaborator
• Qilu Hospital of Shandong University (Qingdao): collaborator
• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, China

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Jun Chen

CONTACT

+86 18560084873; chenjunxinxiang@163.com

Jingchao Liu

CONTACT

+86 18560086740; 15665785012@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: January 30, 2026
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: January 30, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)