Clinical Study of Neoadjuvant Therapy Outcome Prediction of Muscle-invasive Bladder Cancer Based on PTC Drug Sensitivity Detection

Recruiting

• Conditions: Muscle-Invasive Bladder Carcinoma
• Interventions: Diagnostic Test: Patient-derived tumor-like cell clusters (PTC) drug sensitivity testing

• Registration Number: NCT05767528
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

In this study, investigators plan to conduct the 3D in vitro culture PTC drug sensitivity testing of fresh tumor specimen which obtained by endoscopic biopsy or other methods. Through assessing the consistency between the testing results and the patients' neoadjuvant treatment outcomes, they would evaluate the accuracy of PTC drug sensitivity testing and its application value in the individualized precision medicine for muscle-invasive bladder carcinoma.

Detailed Description

This is a prospective observational study. In this study, researchers propose to enroll 40 participants above 18 years of age with muscle-invasive bladder carcinoma, who are going to receive the neoadjuvant therapy before surgery. Collecting fresh tumor samples for PTC drug sensitivity testing, conducting neoadjuvant therapy for the subjects simultaneously. By combining PTC prediction results with the patients' clinical treatment process and medication feedback, researchers could estimate the accuracy of PTC drug sensitivity testing. Completion of this research would provide real-world figures to support for the clinical application for PTC drug sensitivity testing, and a method is going to be established to guide the clinical treatment regimen for patients with muscle-invasive bladder carcinoma.

Study Timeline

• Study Start: 2022-12-08
• Study First Submitted: 2023-02-15
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-11
• Last Update Submitted: 2023-03-11
• Study First Posted: 2023-03-14
• Last Update Posted: 2023-03-14
• Primary Completion: 2023-12-08
• Study Completion: 2024-12-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 1 The lesion of biopsy was diagnosed as muscle-invasive bladder cancer
• 2 Age ≥ 18 years old, regardless of gender
• 3 Treatment plan of bladder removal surgery
• 4 Neoadjuvant therapy before surgery
• 5 Adequate fresh tumor tissue can be obtained by endoscopic biopsy for PTC drug sensitivity testing
• 6 ECOG 0-1, expected survival is more than 3 months
• 7 Normal or stable hepatic, renal, and hematopoietic function
• 8 Normal or stable blood pressure
• 9 The subjects are willing to participate, sign an informed consent form, and have good compliance

Exclusion Criteria

• 1 Patients with incomplete clinical data
• 2 Central nervous system metastasis
• 3 The presence of other malignant diseases was discovered during treatment, which is going to interfere the study
• 4 Researchers believe that the patient is not suitable for participation after comprehensive evaluation
• 5 Refuse the treatment or follow-up plans

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case Group	Patient-derived tumor-like cell clusters (PTC) drug sensitivity testing	Participants who were diagnosed as MIBC and plan to receive neoadjuvant therapy before the surgery, above 18 years of age, regardless of gender

Primary Outcome Measures

Name	Time	Method
Complete Response (CR)	3 months	Disappearance of all target lesions. Any pathological lymph nodes（whether target or non-target）must have reduction in short axis to \<10 mm. Length is measured in millimeters, refers to RECIST 1.1.
Partial Response (PR)	3 months	At least a 30％ decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Length is measured in millimeters, refers to RECIST 1.1.
Progressive Disease (PD)	3 months	At least a 20％ increase in the sum of diameters of target lesions, taking as reference the smallest sum on study（this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20％, the sum must also demonstrate an absolute increase of at least 5 mm.（the appearance of one or more new lesions is also considered progression). Length is measured in millimeters, refers to RECIST 1.1.
Stable Disease (SD)	3 months	Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Length is measured in millimeters, refers to RECIST 1.1.

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China