small cell lung cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed patients with advanced small cell lung cancer who have recurred and or progressed; 2. Have received at least one systemic treatment in the past; 3. Have measurable tumor lesions (spiral CT scan 10mm, meet RECIST 1.1 standard); 4. Expected survival time> 3 months; 5. Age >=18 years old; 6. ECOG PS: 0-2 points; 7. The functions of vital organs meet the following requirements: (1) Absolute neutrophil count >=1.5x10^9/L, platelet >=100x10^9/L, hemoglobin >=9g/dL; (2) Bilirubin 60 mL/min; 8. Women of childbearing age must have a negative pregnancy test (beta HCG) before starting treatment. Women and men of childbearing age (have sex with women of childbearing age) must agree to use effective contraception during treatment and 6 months after the last treatment dose; 9. The patient voluntarily joined the study and signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Suffered from other malignant tumors in the past or at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ; 2. There is active tuberculosis infection. Patients with active pulmonary tuberculosis infection within 1 year before the medication should be excluded even if they have been treated.Patients with a history of active pulmonary tuberculosis infection more than 1 year ago are also excluded, unless it is proven that they have previously received standard anti-tuberculosis treatment; 3. Those who have not effectively controlled, symptomatic brain metastases or have a history of uncontrollable mental illness or have severe intellectual or cognitive dysfunction; 4. Subjects with active, known or suspected autoimmune diseases, hypothyroidism that only needs hormone replacement therapy, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or hair loss) can be selected; 5. Congestive heart failure, uncontrollable arrhythmia, myocardial infarction, unstable angina, stroke or transient ischemic attack within 6 months; 6. Patients who cannot comply with the trial protocol or cannot cooperate with follow-up; 7. There is a history of psychotropic drug abuse, alcohol or drug abuse; 8. Human immunodeficiency virus (HIV, HIV 1/2 antibody) positive; 9. The researcher thinks it is inappropriate to participate in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate;progression-free survival;overall survival; | — |
Countries
China
Contacts
the Affiliated Cancer Hospital of Harbin Medical University