Dendritic Cell Immunotherapy for the Patients With Pancreatic Cancer

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03114631

Enrollment

Registered

2017-04-14

Start date

2017-01-09

Completion date

2019-05-23

Last updated

2019-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dendritic Cells, Pancreatic Neoplasms

Keywords

dendritic cells, pancreatic cancer, immunotherapy

Brief summary

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

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).

Interventions

BIOLOGICALDendritic cells pulsed with tumor lysate

BIOLOGICALDendritic cells pulsed with MUC-1/WT-1 peptides

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants with PR or CR at 1 year	1 year	1 year PR/CR
Number of Participants Who Survived at 1 Year	1 year	1 year overall survival

Secondary

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

Countries

Belarus

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026