Paclitaxel-binding Albumin and Cisplatin as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer

Third Military Medical University50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bladder Cancer

Interventions

Paclitaxel-binding albuminDRUG

Paclitaxel-binding albumin 260 mg/m2，d1，ivgtt；cisplatin 75 mg/m2，d1，ivgtt

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

The Pathologic Complete Response Rate (<pT0) of Neoadjuvant Paclitaxel-binding albumin and Cisplatin in Patients With Muscle-invasive Bladder Cancer.

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.

Time frame: 2 years

Secondary Outcomes

The Pathologic Response Rate (<pT2) of Neoadjuvant Paclitaxel-binding albumin and Cisplatin in Patients With Muscle-invasive Bladder Cancer.

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

Time frame: 2 years

Central Contacts

Dong Wang, PH.D

CONTACT

86-23-68757181 dongwang64@hotmail.com

Data from ClinicalTrials.gov

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