Status:
UNKNOWN
Autologous Dendritic Cells and Allogenic Dendritic Secretomes for Patients With Advanced Nasopharyngeal Cancer
Lead Sponsor:
PT. Prodia Stem Cell Indonesia
Conditions:
Nasopharyngeal Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
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
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05261750
Start Date
April 30 2022
End Date
December 31 2023
Last Update
September 26 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
PT Prodia StemCell Indonesia
Jakarta, Indonesia