small-cell lung cancer
Conditions
Interventions
experimental group:Camrelizumab: 200mg, iv, 30min, q3w, 24 months EP: Etoposide: 100mg/ m2, d1-3, q3w, 4-6 cycles Carboplatin: AUC=5, d1, q3w, 4-6 cycles.
Sponsors
Tangshan People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age:18-75 years old,male or female; 2. Pathologically diagnosed with small cell lung cancer; 3. No prior systemic treatment, immune checkpoint inhibitors therapy(Subjects who have received adjuvant therapy must have experienced a treatment free interval of at least 6 months); 4. At least one measurable lesion (according to RECIST 1.1 standard tumor lesion CT scan long diameter >= 10mm, CT scan of lymph node lesions short diameter >= 15mm); 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; 6. Life expectancy greater than or equal to 3 months; 7. The main organs function well, and the inspection indicators meet the following requirements: 1) For results of blood routine test HB >= 90g/L; ANC >= 1.5 * 10^9/L; PLT >= 100 * 10^9/L; 2) For results of blood biochemical test ALB >= 30g/L ALT and AST <= 2.5 * ULN, but <= 5 * ULN if the transferanse elevation is due to liver metastases TBIL <= 1.5 * ULN Serum creatinine <= 1.5 * ULN; 8.Women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 14 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks. Men must be contraception or has sterilization surgery during the test and the last to have drugs after 8 weeks; 9.Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with symptomatic or untreat brain metastases ; 2. Patients with pia mater metastases; 3. Patients with symptomatic pericardial effusion, pleural effusion and abdominal effusion that require repeated drainage; 4. Subjects with immunosuppressive medications within 14 days of first administration of study treatment, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroid hormones (no more than 10 mg / day of prednisolone or other corticosteroids of equivalent pharmaceutical physiological dose); 5. The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, Hyperthyroidism; patients with vitiligo; Asthma has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included; asthma patients who require bronchodilators for medical intervention cannot be included); 6. Patients with other malignant tumors within 5 years (except for the treated skin basal cell carcinoma and cervical carcinoma in situ); 7. Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV-DNA >= 1000 IU/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the lower limit of detection of the analytical method) or co-infection with hepatitis B and C, requiring antiviral treatment during the study ; 8. 6 months before study drug administration, the following occurred: myocardial infarction, severe / unstable angina pectoris, grade III-IV cardiac insufficiency according to New York Heart Association(NYHA) criteria, uncontrolled arrhythmias (including QTcF interval male > 450 ms, female > 470 ms, the QTcF interval is calculated using Fridericia formula), symptomatic congestive heart failure, cerebrovascular accidents (including transient ischemic attack or symptomatic pulmonary embolism); 9. Severe infections within 4 weeks before study drug administration (eg. Need intravenous drip antibiotics, antifungals or antivirals) or > 38.5 degrees C during screening visits or on the first scheduled day of dosing; 10. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 11. Less than 4 weeks from the last clinical trial; 12. History of psychiatric drugs abuse and can't quit or patients with mental disorders; 13. The researchers think inappropriate.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;DoR;OS;Safty; | — |
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Countries
China
Contacts
Public ContactGuogui Sun
Tangshan People's Hospital
Outcome results
None listed