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Research Protocol for Evaluating the Efficacy of Neoadjuvant Chemotherapy Drugs for Muscle-Invasive Bladder Cancer Based on Organoid Technology.

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 1\. 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.

Locations
Other Locations
China
Qilu Hospital of Shandong University
RECRUITING
Jinan
Contact Information
Primary
Jun Chen
chenjunxinxiang@163.com
+86 18560084873
Backup
Jingchao Liu
15665785012@163.com
+86 18560086740
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 254
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Collaborators: Dezhou Hospital Qilu Hospital of Shandong University, The Second Hospital of Shandong University, Liaocheng People's Hospital, Jining First People's Hospital, Weifang People's Hospital, Taian City Central Hospital, The Affiliated Hospital of Qingdao University, Qianfoshan Hospital, Zibo Central Hospital, Binzhou Medical University, Zaozhuang Municipal Hospital, Yantai Yuhuangding Hospital, Linyi People's Hospital, Shandong Province Third hospital, Qilu Hospital of Shandong University (Qingdao), Shandong Provincial Hospital
Leads: Qilu Hospital of Shandong University

This content was sourced from clinicaltrials.gov