Last updated: September 23, 2022
Sponsor: PT. Prodia Stem Cell Indonesia
Overall Status: Active - Recruiting
Phase
1/2
Condition
Nasopharyngeal Cancer
Treatment
N/AClinical Study ID
NCT05261750
CT/NPC/PSI/2022
Ages 18-80 All Genders
Study Summary
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
Connect with a study center
PT Prodia StemCell Indonesia
Jakarta,
IndonesiaActive - Recruiting
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