extensive-stage small cell lung cancer
Conditions
Sponsors
Heilongjiang General Hospital of Heilongjiang General Hospital of General Bureau of Agricultural Reclamation
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients with advanced extensive stage small cell lung cancer diagnosed by pathology; 2. Have received at least one systemic treatment in the past; 3. With measurable tumor lesions (spiral CT scan >=10mm, meet the RECIST 1.1 standard); 4. The expected survival time is> 3 months; 5. Aged >=18 years old; 6. ECOG PS 0-2 points; 7. The functions of vital organs meet the following requirements; 1) Absolute neutrophil count >= 1.5 x 10^9/L, platelet >=100 x 10^9/L, hemoglobin >= 9g/dL; 2) Bilirubin 60 mL/min; 8. Women of childbearing age must have a negative pregnancy test (ßHCG) before starting treatment. Women of childbearing age and men (have sex with women of childbearing age) must agree to use it uninterruptedly during the treatment period and 6 months after the last therapeutic dose; Contraception; 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 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 abuse or drug abuse; 8. Human immunodeficiency virus (HIV, HIV 1/2 antibody) positive; 9. Researchers believe that it is inappropriate to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;OS;PFS;safety; | — |
Countries
China
Contacts
Public ContactLiu Yongmin
Heilongjiang General Hospital of General Bureau of agricultural reclamation
Outcome results
None listed