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

Completed

• Conditions: Pancreatic Cancer; Chemotherapy Effect; Chemotherapeutic Toxicity
• Interventions: Drug: GS

• Registration Number: NCT03869294
• Lead Sponsor: Zhejiang University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Study First Submitted: 2019-03-08
• Study First Submitted QC: 2019-03-08
• Study First Posted: 2019-03-11
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-02
• Last Update Posted: 2020-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LAPC or MPC patients with GS first-line chemotherapy	GS	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival	2014-01-01 to 2017-12-31	the time from the beginning of chemotherapy to the date of disease progression or death from any cause.
Overall survival	2014-01-01 to 2017-12-31	the time from the beginning of chemotherapy to the date of death from any cause.

Secondary Outcome Measures

Name	Time	Method
Objective response rate	2014-01-01 to 2017-12-31	the percentage of patients with CR or PR
adverse events	2014-01-01 to 2017-12-31

Trial Locations

Locations (1)

First affiliated hospital, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China