NCT02654288

Dynamic Changes of Sera Immunoglobulin G4 and Interleukin-10 in the Patients of Pancreatic Cancer After Chemotherapy

Dynamic Changes of the Serum Level of Immunoglobulin G4(IgG4) and Interleukin-10(IL-10) in the Patients of Pancreatic Cancer After Gemcitabine-based Chemotherapy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Investigators have previously found that the infiltration of immunoglobulin G4(IgG4) positive plasma cells in tumor tissue predicts a poor prognosis of pancreatic cancer after curative resection. Investigators further attempt to explore the possible roles of IgG4 and the inducer of IgG4, interleukin-10(IL-10), in the chemotherapy of pancreatic cancer. In this primary study, investigators plan to observe the dynamic changes of sera IgG4 and IL-10 in peripheral blood after gemcitabine-based chemotherapy and analyze the correlations of IgG4 and IL-10 with the response of gemcitabine and overall survival of pancreatic cancer.

Detailed description

Human immunoglobulin G(IgG) is a family consisting of four members, IgG1, IgG2, IgG3 and IgG4.IgG4 is regarded as an inhibitory IgG which can inhibit the activation of immune responses\[1\]. Recently it was reported that IgG4 could weaken the activation of macrophages to promote cancer progression\[2\]. Autoimmune pancreatitis(AIP) is the most common clinical manifestation of IgG4-related sclerosing diseases(IRSD) which is characterized by abundant infiltration of IgG4 positive plasma cells\[3\].Although there are abundant infiltrations of IgG4 positive plasma cells in pancreatic lesion of AIP, the correlation of IgG4 positive plasma cells with pancreatic cancer has never been reported.Investigators have previously found that higher level of infiltration of IgG4 positive plasma cells in tumor tissue predicts a poor prognosis of pancreatic cancer after curative resection(not published).Investigators further attempt to explore the possible roles of IgG4 and the inducer of IgG4, IL-10, in the chemotherapy of pancreatic cancer.Since gemcitabine is the first line chemotherapeutic drug for pancreatic cancer, in this primary study,investigators plan to observe the dynamic changes of sera IgG4 and IL-10 in peripheral blood after gemcitabine-based chemotherapy and analyze the correlations of IgG4 and IL-10 with the response of gemcitabine and overall survival of pancreatic cancer.

Conditions

• Pancreatic Neoplasms
• Inflammation

Interventions

Type	Name	Description
OTHER	gemcitabine-based chemotherapy

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-12-01
• Completion: 2019-01-01
• First posted: 2016-01-13
• Last updated: 2016-01-26

Locations

1 site across 1 country: China