Clinical trial NCT05261750: Autologous Dendritic Cells and Allogenic Dendritic Secretomes for Patients With Advanced Nasopharyngeal Cancer
Official title: Safety and Efficacy of Adjuvant Therapy of Autologous Dendritic Cells and Allogenic Dendritic Secretomes for Patients With Advanced Nasopharyngeal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Nasopharyngeal Cancer
Keywords: Dendritic Cells
Dendritic Secretomes
Lead sponsor: PT. Prodia Stem Cell Indonesia
Sponsor class: INDUSTRY
First posted: 2022-03-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Karnofsky Performance Status
timeFrame: Before therapy
measure: Karnofsky Performance Status
timeFrame: 1 week after therapy
measure: Karnofsky Performance Status
timeFrame: 1 month after therapy
measure: Karnofsky Performance Status
timeFrame: 3 months after therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: PT Prodia StemCell Indonesia
Study officials:
affiliation: Prodia Stem Cell Indonesia
name: Rima Haifa, B.Sc
role: STUDY_CHAIR
References: