Status:
UNKNOWN
Paclitaxel-binding Albumin and Cisplatin as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer
Lead Sponsor:
Third Military Medical University
Conditions:
Bladder Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 urothe...
Eligibility Criteria
Inclusion
- Age ≥ 18 years.
- 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.
- There was at least one measurable tumor lesion following RECIST 1.1.
- Treatment naïve.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Left ventricular ejection fraction≥50%.
- Absolute neutrophil count (ANC) ≥ 1.5 × 109/L，platelets (PLT) ≥ 100 × 109/L，hemoglobin (Hb) ≥ 90 g/L，leucocyte ≥ 3.0 × 109/L.
- 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.
- Signed informed content obtained prior to treatment.
Exclusion
- Patients who are pregnant or may be pregnant or nursing.
- Patients with Coagulation dysfunction or active internal hemorrhage.
- Patients with uncontrolled active infection，HIV，viral hepatitis.
- Peripheral nerve lesion≥grade 1 following NCI-CTC 5.0.
- 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.
- History of allergic reactions attributed to compounds of similar chemical or biological composition to drugs used in this study.
- Patients was involved in another study within the last 30 days.
- Patients was mental disorders.
- Any other patients deemed by the attending physician to be unsuitable to allow the feasible for this study.
Key Trial Info
Start Date :
October 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04060459
Start Date
October 1 2018
End Date
October 1 2022
Last Update
August 19 2019
Active Locations (1)
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1
Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, China, 400042