Paclitaxel-binding Albumin and Cisplatin as Neoadjuvant C... | NCT04060459

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

NCT04060459

Sponsor

Third Military Medical University

Status

Unknown status

Last Update Posted

Aug 19, 2019Actual

Enrollment

50Estimated

Phase

Phase 2

Conditions

Bladder Cancer

Interventions

Paclitaxel-binding albumin

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2018Actual

Primary Completion Date

Oct 2020Estimated

Completion Date

Oct 2022Estimated

First Submitted Date

Aug 15, 2019

First Submission Date that Met QC Criteria

Aug 15, 2019

First Posted Date

Aug 19, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 15, 2019

Last Update Posted Date

Aug 19, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment plan	Experimental	Paclitaxel-binding albumin 260 mg/m2，d1，ivgtt；cisplatin 75 mg/m2，d1，ivgtt	Drug: Paclitaxel-binding albumin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Paclitaxel-binding albumin	Drug	Paclitaxel-binding albumin 260 mg/m2，d1，ivgtt；cisplatin 75 mg/m2，d1，ivgtt	Treatment plan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	2 years

Secondary Outcomes

Measure	Description	Time Frame
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 (\	2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms