Adoptive Cellular Immunotherapy, Chemotherapy, Extensive Disease, Maintenance, Small Cell Lung Cancer
Conditions
Brief summary
Small cell lung cancer is a highly aggressive malignancy. Currently, there is no effective regimen for patients after the progression offirst-line chemotherapy. The prognosis of patients with extensive disease is very poor, and the improved therapeutic efficacy is urgently needed. Most patients with small cell lung cancer have a long history of smoking, and the tumor mutation burden is relatively high, which provides potential for immunological checkpoint inhibitors represented by PD-1 antibodies. A number of studies have shown that chemotherapy combined with adoptive cellular immunotherapy could prolong the survival of patients. This study is a clinical study to explore the efficacy and safety of maintenance therapy with sintilimab after 4-6 cycles of first-line chemotherapy combined with adoptive cellular immunotherapy in patients with advanced small cell lung cancer.
Interventions
DRUGsintilimab maintenance
the patients with CR, PR or SD after the chemotherapy plus R-CIK will receive sintilimab maintenance therapy. The dose of sintilimab is fixed at 200mg every three weeks.
Sponsors
Henan Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* small cell lung cancer confirmed by pathology * extensive small cell lung cancer by imaging * at least one measurable lesion by RECIST 1.1 * ECOG 0-1 * adequate organ function * no other severe diseases conflicting with this regimen (such as autoimmune diseases, immunodeficiency, organ transplantation, etc) * no history of other maliganancies * Women of childbearing period must examinate for a negative pregnancy test within 7 days, use appropriate contraceptive measures during the study and 6 months after the trial. * agreement to participate in the study and signed informed consent from the patients
Exclusion criteria
* serious infectious diseases four weeks before enrollment * requirement intermittent use of bronchodilators or medical interventions; * the use of immunosuppressants before the enrollment, the amount of immunosuppressant used ≥10mg / day oral prednisone for more than 2 weeks; * severe allergies * severe mental disorders * abnormal coagulation function * previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, severe lung damage, etc. * other situations considered by investigators not meet the inclusion criteria (including but not limited to symptomatic brain metastases)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| median survival time | two years. | the period from the day of enrollment to the date of death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| progression-free survival | six months | the period from the day of enrollment to the date of confirmed progression or death depending on which one occurs first. |
| objective response rate of sintilimab | six month | from the date of first dose of sintilimab to the date of confirmed progression following |
| adverse events rate of sintilimab | one year | the rate of adverse events during the maintenance therapy of sintilimab |
Countries
China
Contacts
Primary ContactQuanli Gao, Dr.
Outcome results
None listed