Study of Sintlimab Maintenance Therapy in Patients With Extensive Small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Study of Sequential Sequential Sintilimab Maintenance Therapy in Patients With Extensive Small Cell Lung Cancer After Chemotherapy Combined With Adoptive Cellular Immunotherapy

Conditions
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Small Cell Lung Cancer, Extensive Disease, Adoptive Cellular Immunotherapy, Chemotherapy, Maintenance

Intervention / Treatment
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* Drug: sintilimab maintenance


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group<br>phlebotomation 50ml 1-7 days before chemotherapy for culture of R-CIK cells chemotherapeutic regimen EP or EC as follows: VP-16 100mg/m2 D1-3 plus cisplatin 75mg/m2 D1 or VP-16 100mg/m2 D1-3 plus carboplatin AUC=5 D1 R-CIK cells were transfused back to the patients 2-7 days after the end of chemotherapy, and the amount of R-CIK cells returned each time was about 5×109 three weeks each cycle efficacy evaluated every two cycles patients with the efficay is CR, PR or SD after 4-6 cycles enter the sintilimab maintenance therapy for one year or until the progression of disease, or occurrence of intolerable adverse events. the dose of sintilimab is fixed dose of 200mg every three weeks | Drug: sintilimab maintenance<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| median survival time | the period from the day of enrollment to the date of death | two years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| objective response rate of sintilimab | from the date of first dose of sintilimab to the date of confirmed progression following | six month | 
| adverse events rate of sintilimab | the rate of adverse events during the maintenance therapy of sintilimab | one year |