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

  • STATUS
    Recruiting
  • End date
    Oct 23, 2022
  • participants needed
    50
  • sponsor
    Third Military Medical University
Updated on 23 January 2021

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.

Details
Condition urinary tract neoplasm, bladder cancer, bladder disorder, Urothelial Cancer, Bladder Disorders, Bladder Carcinoma, Urologic Cancer, carcinoma of the bladder, bladder tumor
Treatment Paclitaxel-binding albumin
Clinical Study IdentifierNCT04060459
SponsorThird Military Medical University
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 80 yrs?
Gender: Male or Female
Do you have any of these conditions: bladder cancer or carcinoma of the bladder or urinary tract neoplasm or Bladder Carcinoma or bladder disorder or Bladder Disorders or Urothelial Cance...?
Age 18 years
Patients must have histologically confirmed resectablestage T2T3 and T4a urothelial carcinoma following 2017 V8 AJCCincluding renal pelvic carcinomaureteral carcinomabladder carcinoma and urethral carcinoma
There was at least one measurable tumor lesion following RECIST 1.1
Treatment nave
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Left ventricular ejection fraction50%
Absolute neutrophil count (ANC) 1.5 109/Lplatelets (PLT) 100 109/Lhemoglobin (Hb) 90 g/Lleucocyte 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 Criteria

Patients who are pregnant or may be pregnant or nursing
Patients with Coagulation dysfunction or active internal hemorrhage
Patients with uncontrolled active infectionHIVviral hepatitis
Peripheral nerve lesiongrade 1 following NCI-CTC 5.0
Patients with serious cardiovasculardisease including history of cerebral vascular accident myocardial infarctionhypertensionanginaheart failureNYHA 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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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