Evaluation of the Efficacy of Anti-HER2 Antibody-Drug Conjugates (ADC) in Locally Advanced or Metastatic Bladder Cancer Based on Organoid Technology.

NCT07379268 | Recruiting

• 1 other identifier: KYLL-202411-010-1
• Study Type: observational
• Target: 224
• Locations: 1 country
• Sites: 1

Brief Summary

This study, through a clinical controlled trial, compares the one-year, two-year, and three-year overall survival rates of patients in the treatment group guided by organoid drug sensitivity intervention with those of patients whose medication was based on HER-2 protein expression levels (IHC method). Univariate Kaplan-Meier survival analysis was used to compare differences in overall survival between the two groups. The study aims to evaluate the application value of tumor organoid drug sensitivity testing in guiding anti-HER2-ADC drug treatment for bladder cancer.

Conditions

Bladder Cancer

Keywords

Organoid; Bladder Cancer

Outcome Measures

Primary Outcomes (1)

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

  One-year overall survival rate, two-year overall survival rate, three-year overall survival rate

  2026.01.01-2028.12.31

Secondary Outcomes (1)

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

  2026.01.01-2028.12.31

Study Arms (2)

Experimental group

Using tumor organoid drug sensitivity tests to detect the sensitivity of patients' tumor cells to the anti-HER2-ADC drug vedicitumumab, the anti-HER2-ADC treatment regimen is only used for patients whose sensitivity to the drug has been confirmed through tumor organoid drug sensitivity testing.

Other: Organoid culture

Control group

Select bladder cancer patients diagnosed during the same period who received anti-HER2-ADC drugs based on HER2 protein overexpression (immunohistochemistry IHC 2 and 3) 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 with unresectable locally advanced (cT4b and/or N2-3) or metastatic bladder cancer (M1) who have failed platinum-based chemotherapy.

You may not qualify if:

• \. 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):
• 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 × the upper limit of normal (ULN) of the institution;
• Estimated glomerular filtration rate (eGFR) ≤ 30 ml/min/1.73m²;
• 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:
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• History or current diagnosis of myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML);
• History of clear neurological or psychiatric disorders, including epilepsy or dementia;
• Severe comorbidities that endanger patient safety or affect study completion (e.g., severe hypertension, diabetes, thyroid disorders);
• Other serious diseases requiring concomitant treatment, with severe laboratory abnormalities;
• Other serious diseases accompanied by family or social factors that could impact participant safety, or the collection of data and samples;
• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead
• 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

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, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 30, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)