Autologous Dendritic Cells and Allogenic Dendritic Secretomes for Patients With Advanced Nasopharyngeal Cancer

Last updated: September 23, 2022
Sponsor: PT. Prodia Stem Cell Indonesia
Overall Status: Active - Recruiting

Phase

1/2

Condition

Nasopharyngeal Cancer

Treatment

N/A

Clinical Study ID

NCT05261750
CT/NPC/PSI/2022
  • Ages 18-80
  • All Genders

Study Summary

The purpose of this study is to determine the safety and potential of dendritic cells therapy and secretomes therapy for advanced nasopharyngeal cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients who tested positive EBV and confirmed suffering advanced nasopharyngealcancer
  • Patients who have partial response or stable disease or progressive disease afterperformed standard therapy (radiology or chemoradiation) based on RECIST
  • Did not take traditional medicine in the last 2 months.
  • Patients can understand the nature of the study and willing to sign informed consent
  • Patients who received standard medical (radiology or chemoradiation) up to oneadditional therapy in the last 1 month.

Exclusion

Exclusion Criteria:

  • Patients who are pregnant, planning to pregnant, or breastfeeding
  • Patients assessed to require chemoradiation during this study
  • Patients who get complete score after undergo standard therapy (radiology orchemoradiation) based on the RECIST
  • Patients who have autoimun reaction, eczema, allergy or allergy history, andanaphylaxis
  • Patients who have creatinin clearance result <40 ml/min, bilirubin serum >1.5x abovenormal, SGPT-SGOT >5x above normal
  • Patients on immunosuppressive medications, such as corticosteroids
  • Patients who undergo Major thoracic or abdominal operation
  • Patients on high medical risk condition due to uncontrolled infection
  • Patients who diagnosed positive of Hepatitis B, Hepatitis C or Human Immunodeificiencyvirus (HIV)
  • Patients who have concurrent congestive heart failure history and other heart disease
  • Patients who have health conditions assessed by the doctor in charge cannot beincluded in this clinical trial
  • Patients who refuse or did not participate in part or all of the research process

Study Design

Total Participants: 15
Study Start date:
April 30, 2022
Estimated Completion Date:
December 31, 2023

Study Description

There are controlled group who receives standard medical theraphy (radiotherapy or chemoradiation), one group who receives standard medical theraphy (radiotherapy or chemoradiation) and Auto-dendritic adjuvant therapy, and other group who receives standard medical theraphy (radiotherapy or chemoradiation) and Allo-dendritic-secretomes adjuvant therapy and continued with auto-dendritic therapy.

Connect with a study center

  • PT Prodia StemCell Indonesia

    Jakarta,
    Indonesia

    Active - Recruiting

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