Neoadjuvant Nab-Paclitaxel And S-1 In Borderline Resectable Pancreatic Cancer

Study Overview

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

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.

N/A

Borderline Resectable Pancreatic Cancer

DRUG: nab-paclitaxel and S-1

HS-1752

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-02-20	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-03-08
First Submitted that Met QC Criteria 2019-02-20	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-03-10
First Posted (ACTUAL) 2019-02-22	Results First Posted N/A	Last Verified 2020-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: nab-paclitaxel and S-1 neoadjuvant chemotherapy with Nab-paclitaxel and S-1, repeat every 21 days for 4 cycles.	DRUG: nab-paclitaxel and S-1 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;

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: nab-paclitaxel and S-1

neoadjuvant chemotherapy with Nab-paclitaxel and S-1, repeat every 21 days for 4 cycles.

DRUG: nab-paclitaxel and S-1

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;

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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: TaiPing Zhang, MD

Phone Number: 13520132976

Email: Tpingzhang@yahoo.com

Study Contact Backup

Name: YueJuan Cheng, MD

Phone Number: 861069158315

Email: cnchengyuejuan@yahoo.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record