Small Cell Lung Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with advanced extensive stage small cell lung cancer confirmed by pathology; 2. Patients who have not received systematic treatment before; 3. Patients with measurable tumor focus (spiral CT scan >= 10 mm, meeting RECIST 1.1 standard); 4. Patients with expected survival time > 3 months; 5. Age: >= 18 years old, both male and female; 6. ECoG PS: 0-2 points; 7. The functions of important organs meet the following requirements: (1) Neutrophil count >= 1.5 * 10^9 / L, platelet >= 100 * 10^9 / L, hemoglobin >= 9 g / dl; (2) Bilirubin 60 ml / min; 8. Women of childbearing age must undergo a negative pregnancy test (ß hCG) before starting treatment. Women of childbearing age and men (who have sex with women of childbearing age) must agree to use effective contraceptive measures continuously during the treatment and 6 months after the last treatment dose; 9. Patients who voluntarily joined the study and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with other malignant tumors, except those with skin basal cell carcinoma and cervical carcinoma in situ that have been cured; 2. Patients with active tuberculosis infection. Patients with active tuberculosis infection within one year before medication should be excluded even if they have been treated. Patients with a history of active tuberculosis infection more than one year ago should also be excluded, unless it is proved that they have received standard anti tuberculosis treatment before; 3. Patients with brain metastases without effective control, symptomatic brain metastases, patients with uncontrollable mental history, or patients with severe intellectual or cognitive dysfunction; 4. Patients with active, known or suspected autoimmune diseases, subjects with hypothyroidism who only need hormone replacement therapy and skin diseases (such as vitiligo, psoriasis or alopecia) without systemic treatment can be enrolled; 5. Patients with congestive heart failure, uncontrollable arrhythmia, myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack within 6 months; 6. Patients with hypertension who cannot be well controlled by single antihypertensive drugs (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); 7. Patients who cannot swallow tablets, malabsorption syndrome or any condition affecting gastrointestinal absorption; Patients with bleeding in the first 8 months, such as bleeding in the gastrointestinal tract, bleeding tendency in the first 8 months; 9. Patients who fail to follow the trial protocol or cooperate with the follow-up; 10. Patients with a history of psychotropic substance abuse, alcoholism or drug abuse; 11. Patients with HIV, HIV 1 / 2 antibody positive; 12. Subjects considered unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;OS;PFS; | — |
Countries
China
Contacts
Affiliated Cancer Hospital of Harbin Medical University