Small Cell Lung Cancer Clinical Trial
Official title:
Clinical Study of Sequential Sequential Sintilimab Maintenance Therapy in Patients With Extensive Small Cell Lung Cancer After Chemotherapy Combined With Adoptive Cellular Immunotherapy
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | May 31, 2021 |
Est. primary completion date | May 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
China | Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Henan Cancer Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | median survival time | the period from the day of enrollment to the date of death | two years. | |
Secondary | progression-free survival | the period from the day of enrollment to the date of confirmed progression or death depending on which one occurs first. | six months | |
Secondary | objective response rate of sintilimab | from the date of first dose of sintilimab to the date of confirmed progression following | six month | |
Secondary | adverse events rate of sintilimab | the rate of adverse events during the maintenance therapy of sintilimab | one year |
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