2017-01-09
2019-05-03
2019-05-23
30
NCT03114631
The Republican Research and Practical Center for Epidemiology and Microbiology
The Republican Research and Practical Center for Epidemiology and Microbiology
INTERVENTIONAL
Dendritic Cell Immunotherapy for the Patients With Pancreatic Cancer
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
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).
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2017-04-11 | N/A | 2019-12-01 |
2017-04-11 | N/A | 2019-12-03 |
2017-04-14 | N/A | 2019-12 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Dendritic cells lysate-pulsed group Patients treated according to clinical protocols plus autologous dendritic cells, pulsed with tumor lysate | BIOLOGICAL: Dendritic cells pulsed with tumor lysate |
| NO_INTERVENTION: Control group Patients treated according to clinical protocols | |
| EXPERIMENTAL: Dendritic cells peptide-pulsed group 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 |
| Primary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
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