Muscle-Invasive Bladder Carcinoma Clinical Trial
Official title:
Clinical Study of Neoadjuvant Therapy Outcome Prediction of Muscle-invasive Bladder Cancer Based on PTC Drug Sensitivity Detection
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 8, 2024 |
Est. primary completion date | December 8, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Chinese PLA General Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Chinese PLA General Hospital | Beijing GeneX Health Technology Co., Ltd |
China,
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete Response (CR) | 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. | 3 months | |
Primary | Partial Response (PR) | 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. | 3 months | |
Primary | Progressive Disease (PD) | 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. | 3 months | |
Primary | Stable Disease (SD) | 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. | 3 months |
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