Dendritic Cell Immunotherapy for the Patients With Pancreatic Cancer

Phase 1

Completed

• Conditions: Dendritic Cells; Pancreatic Neoplasms
• Interventions: Biological: Dendritic cells pulsed with tumor lysate; Biological: Dendritic cells pulsed with MUC-1/WT-1 peptides

• Registration Number: NCT03114631
• Lead Sponsor: The Republican Research and Practical Center for Epidemiology and Microbiology

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).

Study Timeline

• Study Start: 2017-01-09
• Study First Submitted: 2017-04-11
• Study First Submitted QC: 2017-04-11
• Study First Posted: 2017-04-14
• Primary Completion: 2019-05-03
• Study Completion: 2019-05-23
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-01
• Last Update Posted: 2019-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dendritic cells lysate-pulsed group	Dendritic cells pulsed with tumor lysate	Patients treated according to clinical protocols plus autologous dendritic cells, pulsed with tumor lysate
Dendritic cells peptide-pulsed group	Dendritic cells pulsed with MUC-1/WT-1 peptides	Patients treated according to clinical protocols plus autologous dendritic cells, pulsed with MUC-1/WT-1 peptides

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Survived at 1 Year	1 year	1 year overall survival
Number of Participants with PR or CR at 1 year	1 year	1 year PR/CR

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Minsk City Clinical Oncologic Dispensary; 🇧🇾 Minsk, Belarus