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Completed

NCT Number: NCT03869294

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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Key information

Conditions

Pancreatic Cancer Chemotherapeutic Toxicity Chemotherapy Effect Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

First affiliated hospital, Zhejiang University

Hangzhou, Zhejiang, 310006, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GS

Drug

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

Primary outcomes

  1. Progression-free survival

    Time frame: 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.

  2. Overall survival

    Time frame: 2014-01-01 to 2017-12-31

    the time from the beginning of chemotherapy to the date of death from any cause.

Secondary outcomes

  1. Objective response rate

    Time frame: 2014-01-01 to 2017-12-31

    the percentage of patients with CR or PR

  2. adverse events

    Time frame: 2014-01-01 to 2017-12-31

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 11, 2019
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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