Dendritic Cell Immunotherapy for the Patients With Pancreatic Cancer

The Republican Research and Practical Center for Epidemiology and Microbiology30 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dendritic Cells Pancreatic Neoplasms

Interventions

Dendritic cells pulsed with tumor lysateBIOLOGICAL

Dendritic cells pulsed with MUC-1/WT-1 peptidesBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (1)

Minsk City Clinical Oncologic Dispensary

Minsk, Belarus

Outcomes

Primary Outcomes

Number of Participants with PR or CR at 1 year

1 year PR/CR

Time frame: 1 year

Number of Participants Who Survived at 1 Year

1 year overall survival

Time frame: 1 year

Secondary Outcomes

Antigen-specific immune response

The increase of antigen-specific T-cells

Time frame: 1 year

Circulating tumor cells count

Decrease of EpCAM+CD45- circulating tumor cells count

Time frame: 1 year

Immune response

Decrease of T-regulatory cells

Time frame: 1 year

Number of Participants Who Survived at 2 Years

2 year overall survival

Time frame: 2 years

Number of Participants Who Survived at 3 Years or more

3 year overall survival

Time frame: 3 years

Data from ClinicalTrials.gov

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