Clinical trial NCT04060459: Paclitaxel-binding Albumin and Cisplatin as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer
Official title: Paclitaxel-binding Albumin and Cisplatin as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer - A Single-center, Single-arm and Stage II Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Bladder Cancer
Keywords: Bladder cancer；Paclitaxel-binding albumin；Cisplatin；Neoadjuvant Chemotherapy
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2019-08-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The Pathologic Complete Response Rate (<pT0) of Neoadjuvant Paclitaxel-binding albumin and Cisplatin in Patients With Muscle-invasive Bladder Cancer.
timeFrame: 2 years
Secondary outcomes:
measure: The Pathologic Response Rate (<pT2) of Neoadjuvant Paclitaxel-binding albumin and Cisplatin in Patients With Muscle-invasive Bladder Cancer.
timeFrame: 2 years
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Daping Hospital, Third Military Medical University
state: Chongqing
Study officials:
affiliation: Daping Hospital, Third Military Medical University, Chongqing,China
name: Dong Wang
role: PRINCIPAL_INVESTIGATOR
References: