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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05261750
Other study ID # CT/NPC/PSI/2022
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date April 30, 2022
Est. completion date December 31, 2023

Study information

Verified date September 2022
Source PT. Prodia Stem Cell Indonesia
Contact Budi Sulistya, dr
Phone 08121103190
Email s3.abudisulistya@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Intervention

Biological:
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.
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.

Locations

Country Name City State
Indonesia PT Prodia StemCell Indonesia Jakarta

Sponsors (1)

Lead Sponsor Collaborator
PT. Prodia Stem Cell Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Karnofsky Performance Status To measure the patient's Quality of Life. Karnofsky Performance Status can be used to determine patient's prognosis and measured changes of patient's ability to do daily activities which ranges from 0-100. Before therapy
Primary Karnofsky Performance Status To measure the patient's Quality of Life. Karnofsky Performance Status can be used to determine patient's prognosis and measured changes of patient's ability to do daily activities which ranges from 0-100. 1 week after therapy
Primary Karnofsky Performance Status To measure the patient's Quality of Life. Karnofsky Performance Status can be used to determine patient's prognosis and measured changes of patient's ability to do daily activities which ranges from 0-100. 1 month after therapy
Primary Karnofsky Performance Status To measure the patient's Quality of Life. Karnofsky Performance Status can be used to determine patient's prognosis and measured changes of patient's ability to do daily activities which ranges from 0-100. 3 months after therapy
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