Extensive-stage small cell lung cancer
Conditions
Interventions
Sponsors
The First Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Newly treated patients with extensive-stage small cell lung cancer diagnosed by histology; 2. Aged 18 to 75 years old, no gender limit; 3. Physical activity and fitness (ECOG) score 0-2 points, expected to survive for more than 3 months; 4. There are measurable targeted lesions (according to RECIST V1.1); 5. Have sufficient organs and blood biochemical functions, in line with the treatment indications; 6. The pregnancy test is negative for female participants of childbearing age; 7. All participants have no birth plans within 3 years and should take effective contraceptive measures; 8. All the participants are expected to have good compliance; 9. All the participants should participate voluntarily and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients currently participating in other interventional clinical research; 2. Previously received anti-PD-1, anti-PD-L1, anti-CTLA-4 treatment or any other medicine that targets on T cell co-stimulation or immune checkpoint pathways (such as OX40, CD137, etc.); 3. Have received systemic treatment of Chinese herbal medicine with anti-tumor indications or immunomodulatory medicines (including thymosin, interferon, interleukin, except for localized therapy in controlling pleural fluid) within one week before the first administration; 4. Received radiotherapy within 7 days before the first administration; 5. Plan to receive radiotherapy during treatment; 6. Received live attenuated vaccine (or plan to receive live vaccine during the study period) within 4 weeks before the first dose; Note: It is allowed to receive inactivated virus vaccine for seasonal influenza injection within 4 weeks before the first dose; but it is not allowed to receive live attenuated influenza vaccine; 7. Receiving any other immunosuppressive therapy within 7 days before the first administration, excluding local glucocorticoids of nasal spray, inhalation or other routes or physiological doses of systemic glucocorticoids (== 2 weeks after treatment can participate in this study as long as they meet all the following criteria: have measurable lesions except central nervous system; no medulla oblongata or spinal cord metastasis; no history of intracranial hemorrhage; stop hormone therapy 7 days before the first dose of research medicine; 11. Any unstable systemic diseases: including but not limited to active infections, congestive heart failure [New York Heart Association (NYHA) classification >= Grade II], severe arrhythmia requiring medication, liver, kidney or metabolic diseases; Type I and type II respiratory failure; tumor compresses important organs (such as the esophagus), compresses the superior vena cava or invades the mediastinal vessels, heart, etc.; 12. Have human immunodeficiency virus (HIV) infection history (ie HIV1/2 antibody positive) and active syphilis; 13. Active or current tuberculosis that requires medical intervention, including but not limited to tuberculosis; 14. Untreated active hepatitis B; Note: Hepatitis B participants who meet the following criteria meet the inclusion criteria: Hepatitis B virus (HBV) load must be < 1000 copies/ml (200IU/ml) before the first dose or below the lower limit of detection, anti-HBV treatment should be received during the entire study chemotherapy drug treatment to avoid viral reactivation. For participants with hepatitis B core antibody (HBcAb) (+), hepatitis B surface antigen (HBsAg) (-), hepatitis B surface antibody (HBsAb) (-) and HBV viral
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year PFS rate;Safety evaluation;Evaluation of quality of life; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Objective response rate;Overall survival;Duration of response; | — |
Countries
China
Contacts
Public ContactZhao Mingfang
The First Hospital of China Medical University
Outcome results
None listed