NCT07379281

Brief Summary

This study, through a clinical controlled trial, compared the one-year, three-year, and five-year overall survival rates between patients receiving a treatment plan guided by organoid drug sensitivity and those receiving conventional empirical treatment. Univariate Kaplan-Meier survival analysis was used to compare the differences in overall survival between the two groups. The study aimed to evaluate the application value of tumor organoid drug sensitivity testing in guiding neoadjuvant chemotherapy for bladder cancer.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
254

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Jan 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Jan 2025Dec 2030

Study Start

First participant enrolled

January 1, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 30, 2026

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

January 30, 2026

Status Verified

December 1, 2025

Enrollment Period

6 years

First QC Date

January 23, 2026

Last Update Submit

January 23, 2026

Conditions

Bladder Cancer

Keywords

OrganoidBladder 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 (2)

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

    2026.01.01-2030.12.31

  • CRR,CPR,ORR

    2025.01.01-2025.12.31

Study Arms (2)

Experimental group

Using tumor organoid drug sensitivity tests to assess the sensitivity of patients' tumor cells to six neoadjuvant chemotherapy drugs, in order to develop a neoadjuvant chemotherapy regimen.

Other: Organoid culture

Control group

Bladder cancer patients who underwent radical surgery during the same period and received neoadjuvant chemotherapy according to the standard regimen were selected as the control group.

Interventions

Organoid cultureOTHER

Organoid culture of tumor tissue obtained during patient surgery

Experimental group

Eligibility Criteria

Age18 Years - 80 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \. 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.

You may not qualify if:

  • \. 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)
  • \) 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, China

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Central Study Contacts

Jun Chen

CONTACT

+86 18560084873chenjunxinxiang@163.com

Jingchao Liu

CONTACT

+86 1856008674015665785012@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)