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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03869294
Recruitment Status : Completed
First Posted : March 11, 2019
Last Update Posted : March 15, 2019
Information provided by (Responsible Party):
Weijia Fang, MD, 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.

Condition or disease Intervention/treatment
Pancreatic Cancer Chemotherapy Effect Chemotherapeutic Toxicity Drug: GS

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Study Type : Observational [Patient Registry]
Actual Enrollment : 96 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Gemcitabine Plus S-1 as the First-line Chemotherapy in Chinese Patients With Advanced Pancreatic Cancer
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Gemcitabine

Group/Cohort 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 :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All advanced pancreatic cancer patients are diagnosed by histology to have pancreatic adenocarcinoma after a biopsy and received first-line GS chemotherapy at the Cancer Biotherapy Center of the First Affiliated Hospital.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03869294

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China, Zhejiang
First affiliated hospital, Zhejiang University
Hangzhou, Zhejiang, China, 310006
Sponsors and Collaborators
Zhejiang University

Additional Information:

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Responsible Party: Weijia Fang, MD, director, Zhejiang University Identifier: NCT03869294     History of Changes
Other Study ID Numbers: ZYYY-PAC1
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs