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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02654288
• Other study ID #: 81272573
• Status: Recruiting
• Phase: N/A
• First received: January 11, 2016
• Last updated: January 24, 2016
• Start date: January 2016
• Est. completion date: January 2019

Study information

• Verified date: December 2015
• Source: Peking Union Medical College Hospital
• Contact: Qiaofei Liu, MD
• Phone: 86-15201693370
• Email: qfliu[@]aliyun.com
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age ranging from 18 to 75-year old;

2. Pathological verified pancreatic cancer including adenocarcinoma and cancerogenesis of intraductal papillary mucinous neoplasm (IPMN);

3. Pancreatic cancer patients receiving adjuvant chemotherapy after curative resection; pancreatic cancer patients with recurrent lesions receiving chemotherapy after curative resection; pancreatic cancer patients with unresectable tumor receiving chemotherapy;

4. Patients have good physical status to receive chemotherapy;

5. No history of chemotherapy and the current regimen contains gemcitabine;

6. No medical history of IgG4 related diseases and other connective tissue diseases;

7. Written consent is available.

Exclusion Criteria:

1. Patient younger than 18-year old;

2. Patient has chemotherapy before;

3. The physical status is too poor to receive chemotherapy;

4. The patient has history of IgG4 related diseases and some other connective diseases;

5. Written consent is not available.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Inflammation
• Pancreatic Neoplasms

Intervention

Other:
• gemcitabine-based chemotherapy

Locations

Country	Name	City	State
China	Department of General Surgery, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

References & Publications (3)

Davies AM, Sutton BJ. Human IgG4: a structural perspective. Immunol Rev. 2015 Nov;268(1):139-59. doi: 10.1111/imr.12349. Review. — View Citation

Karagiannis P, Gilbert AE, Josephs DH, Ali N, Dodev T, Saul L, Correa I, Roberts L, Beddowes E, Koers A, Hobbs C, Ferreira S, Geh JL, Healy C, Harries M, Acland KM, Blower PJ, Mitchell T, Fear DJ, Spicer JF, Lacy KE, Nestle FO, Karagiannis SN. IgG4 subclass antibodies impair antitumor immunity in melanoma. J Clin Invest. 2013 Apr;123(4):1457-74. — View Citation

Karagiannis P, Villanova F, Josephs DH, Correa I, Van Hemelrijck M, Hobbs C, Saul L, Egbuniwe IU, Tosi I, Ilieva KM, Kent E, Calonje E, Harries M, Fentiman I, Taylor-Papadimitriou J, Burchell J, Spicer JF, Lacy KE, Nestle FO, Karagiannis SN. Elevated IgG4 in patient circulation is associated with the risk of disease progression in melanoma. Oncoimmunology. 2015 Jun 3;4(11):e1032492. eCollection 2015 Nov. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The dynamic change patterns of sera IgG4 and IL-10 of pancreatic cancer after gemcitabine-based chemotherapy will be recorded.	Investigators attempt to analyze the dynamic change patterns of sera IgG4 and IL-10 of pancreatic cancer after gemcitabine-based chemotherapy and theoretically investigators imagine that the sera IgG4 and IL-10 will be elevated in most of the patients.	one year	No
Secondary	The correlation of the changes of IgG4 and IL-10 with the tumor marker during chemotherapy will be analyzed	The sera IgG4 and IL-10 and tumor marker will be detected during chemotherapy and the correlations will be analyzed.	one year	No
Secondary	The correlation of the changes of IgG4 and IL-10 with the efficacy of chemotherapy evaluated by intravenous enhanced CT during chemotherapy will be analyzed	The sera IgG4 and IL-10 will be detected during chemotherapy and the chemotherapeutic efficacy will be evaluated by intravenous enhanced CT scan and the correlation will be analyzed.	one year	No
Secondary	The correlation of the changes of IgG4 and IL-10 with the overall survival after chemotherapy will be analyzed.	The sera IgG4 and IL-10 will be detected during chemotherapy and the overall survival will be recorded and then the correlation will be analyzed.	Two year	No