Neoadjuvant Nab-Paclitaxel and S-1 in Borderline Resectab... | NCT03850769

Studies
Neoadjuvant Nab-Paclitaxel and S-1 in Borderline Resectable Pancreatic Cancer

NCT03850769

Sponsor

Peking Union Medical College Hospital

Status

Unknown status

Last Update Posted

Mar 10, 2020Actual

Enrollment

60Estimated

Phase

Phase 2

Conditions

Borderline Resectable Pancreatic Cancer

Interventions

nab-paclitaxel and S-1

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

Feb 2020

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

May 1, 2019Actual

Primary Completion Date

Mar 2022Estimated

Completion Date

Apr 2022Estimated

First Submitted Date

Feb 20, 2019

First Submission Date that Met QC Criteria

Feb 20, 2019

First Posted Date

Feb 22, 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

Mar 8, 2020

Last Update Posted Date

Mar 10, 2020Actual

Description Module

Brief Summary

This study was a single-arm multicenter prospective phase II clinical study, designed to evaluate the efficacy and safety of neoadjuvant nab-paclitaxel combined with S-1 in patients with borderline resectable pancreatic cancer. A total of 60 subjects who meet the criteria will receive neoadjuvant chemotherapy of nab-paclitaxel and S-1, for a maximum of 4 cycles prior to pancreatectomy. The primary endpoint is R0 resection rate, the secondary endpoints include overall survival and response rate.

Detailed Description

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
nab-paclitaxel and S-1	Experimental	neoadjuvant chemotherapy with Nab-paclitaxel and S-1, repeat every 21 days for 4 cycles.	Drug: nab-paclitaxel and S-1

Interventions

Name	Type	Description	Arm Group Labels	Other Names
nab-paclitaxel and S-1	Drug	Nab-Paclitaxel: 120 mg/m2 d1, 8, S-1: Body surface area < 1.25 m2, 80 mg/d; Body surface area ≥ 1.25 m2 < 1.50 m2, 100 mg/d; Body surface area ≥1.5 m2, 120 mg/d; Bid, d1-14;

Measure	Description	Time Frame
R0 resection rate	proportion of patients who achieved R0 resection	3 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients have good compliance, can understand the research process of this study, and sign a written informed consent
Patients with pathologically confirmed pancreatic adenocarcinoma.
Patients who have not received prior chemotherapy, radiotherapy or other systematic treatment for pancreatic cancer;
Patients with borderline resectable pancreatic cancer ( NCCN Version 1，2019 criteria).
ECOG PS 0-1;
Tumor size is measurable according to RECIST1.1 criteria
Expected survival over 3 months;
Bone marrow function: neutrophils≥1.5x109/L, platelets ≥100x109/L, hemoglobin≥ 90g/L;
Liver and kidney function: serum creatinine≤1.5ULT; AST and ALT≤ 2.5 ULT; total bilirubin ≤ 1.5 ULT;
No contraindications to the use of S-1 and nab-paclitaxel.

Exclusion Criteria:

≥ Grade 2 existing peripheral neuropathy;
Any other malignancy within 5 years prior to enrollment, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, bladder, or nonmelanomatous skin cancer.
Active, uncontrolled infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate treatment.
Severe, active co-morbidity, defined as follows:

Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months Transmural myocardial infarction within the 6 months of study registration Uncontrolled hypertension, diabetes or arrhythmia. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization.
Not able to take medicine orally.
Pregnancy or lactation, and women of childbearing age who refused to take appropriate contraceptive measures during the course of this study;
Participation in other clinical trial within 30 days before the first dose of the drug;

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
TaiPing Zhang, MD	Contact	13520132976		Tpingzhang@yahoo.com
YueJuan Cheng, MD	Contact	861069158315		cnchengyuejuan@yahoo.com

ID	Term
C520255	130-nm albumin-bound paclitaxel
C079198	S 1 (combination)