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NCT Number: NCT03114631

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

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Key information

Conditions

Dendritic Cells Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Minsk City Clinical Oncologic Dispensary

Minsk, 220000, Belarus

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dendritic cells pulsed with tumor lysate

Biological

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

Biological

Primary outcomes

  1. Number of Participants with PR or CR at 1 year

    Time frame: 1 year

    1 year PR/CR

  2. Number of Participants Who Survived at 1 Year

    Time frame: 1 year

    1 year overall survival

Secondary outcomes

  1. Antigen-specific immune response

    Time frame: 1 year

    The increase of antigen-specific T-cells

  2. Circulating tumor cells count

    Time frame: 1 year

    Decrease of EpCAM+CD45- circulating tumor cells count

  3. Immune response

    Time frame: 1 year

    Decrease of T-regulatory cells

  4. Number of Participants Who Survived at 2 Years

    Time frame: 2 years

    2 year overall survival

  5. Number of Participants Who Survived at 3 Years or more

    Time frame: 3 years

    3 year overall survival

Sponsors and collaborators

Lead sponsor

The Republican Research and Practical Center for Epidemiology and Microbiology

Other

Collaborators

  • Belarusian State Medical University

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 14, 2017
Registry last updated
Dec 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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