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

NCT ID: NCT05261750

Last Updated: 2022-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-30

Study Completion Date

2023-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Nasopharyngeal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Auto-Dendritic Adjuvant Therapy

Patients will be given standard medical therapy (radiotherapy or chemoradiation) and auto-dendritic adjuvant therapy via intramuscular 3 times injection every 1 week.

Group Type EXPERIMENTAL

Auto-Dendritic Adjuvant Therapy

Intervention Type BIOLOGICAL

Treatment with standard medical therapy (radiotherapy or chemoradiation) and auto-dendritic adjuvant therapy via intramuscular 3 times injection every 1 week.

Allo-Dendritic-secretome and Auto-Dendritic Adjuvant Therapy

Patients will be given standrad medical therapy (radiotherapy or chemoradiation) and allo-dendritic-secretome adjuvant therapy 2 cc 1 times injection, and then followed by auto-dendritic therapy via intramuscular 3 times injection every 1 week.

Group Type EXPERIMENTAL

Allo-Dendritic-Secretome Adjuvant Therapy

Intervention Type BIOLOGICAL

Treatment with standard medical therapy (radiotherapy or chemoradiation) and allo-dendritic-secretome adjuvant therapy 2 cc 1 times injection, and then followed by auto-dendritic therapy via intramuscular 3 times injection every 1 week.

Interventions

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Auto-Dendritic Adjuvant Therapy

Treatment with standard medical therapy (radiotherapy or chemoradiation) and auto-dendritic adjuvant therapy via intramuscular 3 times injection every 1 week.

Intervention Type BIOLOGICAL

Allo-Dendritic-Secretome Adjuvant Therapy

Treatment with standard medical therapy (radiotherapy or chemoradiation) and allo-dendritic-secretome adjuvant therapy 2 cc 1 times injection, and then followed by auto-dendritic therapy via intramuscular 3 times injection every 1 week.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Patients who tested positive EBV and confirmed suffering advanced nasopharyngeal cancer
* Patients who have partial response or stable disease or progressive disease after performed 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 one additional therapy in the last 1 month.

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 or chemoradiation) based on the RECIST
* Patients who have autoimun reaction, eczema, allergy or allergy history, and anaphylaxis
* Patients who have creatinin clearance result \<40 ml/min, bilirubin serum \>1.5x above normal, 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 Immunodeificiency virus (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 be included in this clinical trial
* Patients who refuse or did not participate in part or all of the research process
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PT. Prodia Stem Cell Indonesia

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rima Haifa, B.Sc

Role: STUDY_CHAIR

Prodia Stem Cell Indonesia

Locations

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PT Prodia StemCell Indonesia

Jakarta, , Indonesia

Site Status RECRUITING

Countries

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Indonesia

Central Contacts

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Budi Sulistya, dr

Role: CONTACT

08121103190

Cynthia Retna Sartika, Dr

Role: CONTACT

Other Identifiers

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CT/NPC/PSI/2022

Identifier Type: -

Identifier Source: org_study_id

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