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

Pancreatic Cancer Clinical Trial

Official title:

Gemcitabine Plus S-1 as the First-line Chemotherapy in Chinese Patients With Advanced Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03869294
• Other study ID #: ZYYY-PAC1
• Status: Completed
• Start date: January 1, 2014
• Est. completion date: December 31, 2017

Study information

• Verified date: March 2020
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapeutic Toxicity
• Chemotherapy Effect
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	First affiliated hospital, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Objective response rate	the percentage of patients with CR or PR	2014-01-01 to 2017-12-31
Secondary	adverse events		2014-01-01 to 2017-12-31