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

• Conditions: Pancreatic Neoplasms; Inflammation
• Interventions: Other: gemcitabine-based chemotherapy

• Registration Number: NCT02654288
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

Study Timeline

• Status Verified: 2015-12
• Study Start: 2016-01
• Study First Submitted: 2016-01-11
• Study First Submitted QC: 2016-01-11
• Study First Posted: 2016-01-13
• Last Update Submitted: 2016-01-24
• Last Update Posted: 2016-01-26
• Primary Completion: 2018-12
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
single arm	gemcitabine-based chemotherapy	The pancreatic cancer patients without history of chemotherapy who will receive gemcitabine-based chemotherapy will be recruited and the sera IgG4 and IL-10 will be detected before and after chemotherapy.

Primary Outcome Measures

Name	Time	Method
The dynamic change patterns of sera IgG4 and IL-10 of pancreatic cancer after gemcitabine-based chemotherapy will be recorded.	one year	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.

Secondary Outcome Measures

Name	Time	Method
The correlation of the changes of IgG4 and IL-10 with the tumor marker during chemotherapy will be analyzed	one year	The sera IgG4 and IL-10 and tumor marker will be detected during chemotherapy and the correlations will be analyzed.
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	one year	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.
The correlation of the changes of IgG4 and IL-10 with the overall survival after chemotherapy will be analyzed.	Two year	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.

Trial Locations

Locations (1)

Department of General Surgery, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China