Bladder Cancer
Conditions
Keywords
Bladder cancer；Paclitaxel-binding albumin；Cisplatin；Neoadjuvant Chemotherapy
Brief summary
This is a phase II study of Paclitaxel-binding albumin, Cisplatin as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.
Interventions
DRUGPaclitaxel-binding albumin
Paclitaxel-binding albumin 260 mg/m2，d1，ivgtt；cisplatin 75 mg/m2，d1，ivgtt
Sponsors
Third Military Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age ≥ 18 years. 2. Patients must have histologically confirmed resectable（stage T2，T3 and T4a） urothelial carcinoma following 2017 V8 AJCC，including renal pelvic carcinoma，ureteral carcinoma，bladder carcinoma and urethral carcinoma. 3. There was at least one measurable tumor lesion following RECIST 1.1. 4. Treatment naïve. 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 6. Left ventricular ejection fraction≥50%. 7. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L，platelets (PLT) ≥ 100 × 109/L，hemoglobin (Hb) ≥ 90 g/L，leucocyte ≥ 3.0 × 109/L. 8. Total bilirubin (TBIL) ≤ 1.5 ×institutional upper limit of normal (ULN)， Alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase \[SGPT\]) /Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]≤ 2.5 ×ULN ，Creatinine (CRE) ≤ 1.5 ×ULN. 9. Signed informed content obtained prior to treatment.
Exclusion criteria
1. Patients who are pregnant or may be pregnant or nursing. 2. Patients with Coagulation dysfunction or active internal hemorrhage. 3. Patients with uncontrolled active infection，HIV，viral hepatitis. 4. Peripheral nerve lesion≥grade 1 following NCI-CTC 5.0. 5. Patients with serious cardiovasculardisease including history of cerebral vascular accident ， myocardial infarction，hypertension，angina，heart failure（NYHA grade 2-4） within the last 6 months. 6. History of allergic reactions attributed to compounds of similar chemical or biological composition to drugs used in this study. 7. Patients was involved in another study within the last 30 days. 8. Patients was mental disorders. 9. Any other patients deemed by the attending physician to be unsuitable to allow the feasible for this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Pathologic Complete Response Rate (<pT0) of Neoadjuvant Paclitaxel-binding albumin and Cisplatin in Patients With Muscle-invasive Bladder Cancer. | 2 years | Complete pathologic response to neoadjuvant GCS is the primary endpoint is defined as the absence of carcinoma (pT0 disease) and the absence of microscopic lymph node metastases (N0) on the final cystectomy specimen. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Pathologic Response Rate (<pT2) of Neoadjuvant Paclitaxel-binding albumin and Cisplatin in Patients With Muscle-invasive Bladder Cancer. | 2 years | is defined as the absence of muscle invasive carcinoma (\<pT2 disease) and the absence of microscopic lymph node metastases (N0) on the final cystectomy specimen |
Countries
China
Contacts
Primary ContactDong Wang, PH.D
Outcome results
None listed