Dendritic Cell Immunotherapy for the Patients With Pancreatic Cancer

Study Overview
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Brief Summary
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The trial evaluates the safety and efficacy of MUC-1/WT-1 peptide and/or tumor lysate-pulsed dendritic cell Immunotherapy for the patients with pancreatic cancer

Detailed Description
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The trial evaluates the safety and efficacy of dendritic cell Immunotherapy for the patients with pancreatic cancer. Dendritic cells are obtained from blood monocytes using standard protocol. Two options for dendritic cell priming are used: MUC-1/WT-1 peptides for the patients with unresectable tumor and/or tumor lysates for the patients undergoing tumor resection. The dendritic cells are them matured and injected subcutaneous (all patients) and intratumorally (when possible).

Official Title
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Single-center Trial Evaluating the Safety and Efficacy of MUC-1/WT-1 Peptide or Tumor Lysate-pulsed Dendritic Cell Immunotherapy for the Patients With Pancreatic Cancer

Conditions
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Dendritic Cells, Pancreatic Neoplasms

Intervention / Treatment
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* Biological: Dendritic cells pulsed with tumor lysate
* Biological: Dendritic cells pulsed with MUC-1/WT-1 peptides


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically or cytologically confirmed pancreatic cancer (adenocarcinoma); HLA-A2 expression by tumor cells; WT-1/MUC-1 expression by tumor cells. Exclusion Criteria: refuse of patient to participate in the trial; pregnancy/lactation; intercurrent severe chronic diseases; HIV, Hepatites B/C; active tuberculosis; alcohol use disorder/drug addiction.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dendritic cells lysate-pulsed group<br>Patients treated according to clinical protocols plus autologous dendritic cells, pulsed with tumor lysate | Biological: Dendritic cells pulsed with tumor lysate<br> <br> |
| No Intervention: Control group<br>Patients treated according to clinical protocols | |
| Experimental: Dendritic cells peptide-pulsed group<br>Patients treated according to clinical protocols plus autologous dendritic cells, pulsed with MUC-1/WT-1 peptides | Biological: Dendritic cells pulsed with MUC-1/WT-1 peptides<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with PR or CR at 1 year | 1 year PR/CR | 1 year | 
| Number of Participants Who Survived at 1 Year | 1 year overall survival | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antigen-specific immune response | The increase of antigen-specific T-cells | 1 year | 
| Circulating tumor cells count | Decrease of EpCAM+CD45- circulating tumor cells count | 1 year | 
| Immune response | Decrease of T-regulatory cells | 1 year | 
| Number of Participants Who Survived at 2 Years | 2 year overall survival | 2 years | 
| Number of Participants Who Survived at 3 Years or more | 3 year overall survival | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dendritic cells, pancreatic cancer, immunotherapy