GS Regimen As The First-line Chemotherapy In Chinese Advanced PC Patients

Study Overview

GS Regimen as the First-line Chemotherapy in Chinese Advanced PC Patients

Gemcitabine plus S-1 (GS) prolonged progression-free survival (PFS) and greatly improved objective response rate (ORR) as well as disease control rate (DCR) of Asian patients with locally advanced and metastatic pancreatic cancer (PC). However, limited data of GS regimen exist on the efficacy and safety in the treatment of Chinese patients with advanced PC. To assess the efficacy and safety of gemcitabine plus S-1 (GS regimen) as the first-line chemotherapy in Chinese patients with advanced PC, we designed this prospective study.

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Pancreatic Cancer
Chemotherapy Effect
Chemotherapeutic Toxicity

DRUG: GS

ZYYY-PAC1

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 2019-03-08	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-03-02
First Submitted that Met QC Criteria 2019-03-08	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-03-04
First Posted (ACTUAL) 2019-03-11	Results First Posted N/A	Last Verified 2020-03

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:
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Allocation:
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Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: LAPC or MPC patients with GS first-line chemotherapy	DRUG: GS Gemcitabine plus S-1 (GS) was used to treat advanced pancreatic cancer

Participant Group/Arm

Intervention/Treatment

: LAPC or MPC patients with GS first-line chemotherapy

DRUG: GS

Gemcitabine plus S-1 (GS) was used to treat advanced pancreatic cancer

Primary Outcome Measures	Measure Description	Time Frame
Progression-free survival	the time from the beginning of chemotherapy to the date of disease progression or death from any cause.	2014-01-01 to 2017-12-31
Overall survival	the time from the beginning of chemotherapy to the date of death from any cause.	2014-01-01 to 2017-12-31

Secondary Outcome Measures	Measure Description	Time Frame
Objective response rate	the percentage of patients with CR or PR	2014-01-01 to 2017-12-31
adverse events		2014-01-01 to 2017-12-31

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:

1.Histologically confirmed pancreatic adenocarcinoma 2.Locally advanced or metastatic PC 3.Chemotherapy-naïve 4.ECOG performance status of 0 or 1 5. An adequate bone marrow, liver function and kidney function

1.Age ≥80 years 2.Brain metastasis 3.With other malignancies 4.Chronic diarrhea, cardiac disease, pregnancy or breast feeding

Collaborators and Investigators

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

Publications

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Clinical Trial Record