Neoadjuvant Chemotherapy For Pancreatic Cancer Followed By GS And GnP

Study Overview

Neoadjuvant Chemotherapy for Pancreatic Cancer Followed by GS and GnP

The effect of neoadjuvant chemotherapy for pancreatic cancer was gradually established. However it has been not clarified which regimen of neoadjuvant treatment for pancreatic cancer is the best.

gemcitabine plus S-1 versus gemcitabine plus nab-paclitaxel

Pancreatic Adenocarcinoma

DRUG: GS
DRUG: GnP

GSGnP

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 2022-02-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-02-24
First Submitted that Met QC Criteria 2022-02-24	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-03-07
First Posted (ACTUAL) 2022-03-07	Results First Posted N/A	Last Verified 2022-02

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:
Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: GS gemcitabine plus S-1	DRUG: GS drip infusion of gemcitabine plus oral administration of S-1 S-1 received S-1 orally twice daily at a dose calculated according to body-surface area (BSA) (< 1.25 m2, 60 mg/d; ≥ 1.25 to < 1.5 m2, 80 mg/d; ≥ 1.5 m2, 100 mg/d) on days 1 through 14 of a 21-d
ACTIVE_COMPARATOR: GnP gemcitabine plus nab-paclitaxel	DRUG: GnP drip infusion of both gemcitabine and nab-paclitacel gemcitabine received gemcitabine intravenously at a dose of 800 mg/m2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle. nab-paclitaxel received nab-paclitaxel intravenously at a dose of 100 mg/m2

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: GS

gemcitabine plus S-1

DRUG: GS

drip infusion of gemcitabine plus oral administration of S-1 S-1 received S-1 orally twice daily at a dose calculated according to body-surface area (BSA) (< 1.25 m2, 60 mg/d; ≥ 1.25 to < 1.5 m2, 80 mg/d; ≥ 1.5 m2, 100 mg/d) on days 1 through 14 of a 21-d

ACTIVE_COMPARATOR: GnP

gemcitabine plus nab-paclitaxel

DRUG: GnP

drip infusion of both gemcitabine and nab-paclitacel gemcitabine received gemcitabine intravenously at a dose of 800 mg/m2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle. nab-paclitaxel received nab-paclitaxel intravenously at a dose of 100 mg/m2

Primary Outcome Measures	Measure Description	Time Frame
overall survival	postoperative survival	5 years

Secondary Outcome Measures	Measure Description	Time Frame
adverse events	incidence of adverse events for neoadjuvant chemotherapy for pancreatic cancer	up to 24 weeks

Contacts and Locations

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

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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Resources

Patients

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Clinical Trial Record