Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
advanced non-small cell lung cancer, cell based therapy, safety, clinical efficacy
Brief summary
The study is aimed to the test the efficacy and safety of neoantigen-primed dendritic cell (DC) cell vaccine therapy for refractory non-small cell lung cancer.
Detailed description
Patients with pathological confirmed non-small cell lung cancer with no standard treatment are enrolled. The patients fails in previous at least 2 lines of chemotherapy and 1 line of targeted therapy where applicable. This is a prospective exploratory trial. Patients' rebiopsy tumor tissues are subsequent to whole exosome sequencing and possible neoantigens are identified. DC is in vitro primed with synthesized peptides. Both adverse events and responses are recorded.
Interventions
BIOLOGICALDC vaccine
subcutaneous administration
Sponsors
Sichuan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* pathologically confirmed non-small cell lung cancer * failed in previous standard chemotherapy and targeted therapy * anticipated life time \> 3month * Karnofsky performance status 0-1 * rehabilitate from previous therapy * adequate organ functions
Exclusion criteria
* mixed histological types * tumor emergency * abnormal coagulation condition * contagious diseases, such as hepatitis B virus, hepatitis C virus, human immunodefficiency virus, tuberculosis infection * concomitant tumors * immunological co-morbidities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 3 months after the last administration of cells | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate | through study completion, an average of 1 year | Number of participants with objective responses as assayed by RECIST 1.1 |
Countries
China
Contacts
Primary ContactZhen-Yu Ding, Prof
Outcome results
None listed