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

NCT03869294 | Completed

• 1 other identifier: ZYYY-PAC1
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer; Chemotherapy Effect; Chemotherapeutic Toxicity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Objective response rate

  2014-01-01 to 2017-12-31

• adverse events

  2014-01-01 to 2017-12-31

Study Arms (1)

LAPC or MPC patients with GS first-line chemotherapy

Drug: GS

Interventions

GS DRUG

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

LAPC or MPC patients with GS first-line chemotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

First affiliated hospital, Zhejiang University

Hangzhou, Zhejiang, 310006, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 11, 2019
• Study Start: January 1, 2014
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: March 4, 2020

Record last verified: 2020-03

Locations

CN (1)