Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Inflammation | — | UNRESOLVED | — |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine-based chemotherapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- single arm
- description
- 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.
- interventionNames
- Other: gemcitabine-based chemotherapy
Primary outcomes (1)
- measure
- The dynamic change patterns of sera IgG4 and IL-10 of pancreatic cancer after gemcitabine-based chemotherapy will be recorded.
- timeFrame
- one year
- description
- 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 outcomes (3)
- measure
- The correlation of the changes of IgG4 and IL-10 with the tumor marker during chemotherapy will be analyzed
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDDavies AM, Sutton BJ. Human IgG4: a structural perspective. Immunol Rev. 2015 Nov;268(1):139-59. doi: 10.1111/imr.12349. PMID 26497518
- BACKGROUNDKaragiannis 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. doi: 10.1080/2162402X.2015.1032492. eCollection 2015 Nov. PMID 26451312
- BACKGROUNDKaragiannis 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. doi: 10.1172/JCI65579. PMID 23454746