Small cell lung cancer
Conditions
Interventions
test group:Trilaciclibe
Sponsors
Tangdu Hospital, Fourth Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. sign a written informed consent form before enrollment; 2. age > 18 years, both men and women; 3. histologically and cytologically confirmed diagnosis of extensive stage small cell lung cancer (ES-CLC, according to the American Veterans Administration Lung Cancer Society (VALG) disease staging system) 4. Grade 3-4 chemotherapy-related myelosuppression caused by platinum-based chemotherapy ± PD-1/PD-L1 first-line therapy, which recovers to = Grade 2 after treatment or control; 5. laboratory tests meet the following criteria: (1) Hemoglobin = 80 g/L (2) Neutrophil count = 1.0 × 10^9/L (3) Platelet count = 80 × 10^9/L; (4) Creatinine = 15 mg/L or creatinine clearance (CrCl) = 60 mL/min (Cockcroft-Gault formula); (5) Total bilirubin = 1.5 × upper limit of normal (ULN); (6) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3 × ULN or = 5 × ULN (patients with liver metastases); 6. expected survival time = 12 weeks; 7. the presence of at least one measurable lesion that meets RECIST1.1 criteria; 8.All females of childbearing potential must have a negative serum pregnancy test at screening and male and female subjects must use reliable contraception from signing of informed consent through 3 months after the last dose;
Exclusion criteria
Exclusion criteria: 1. refusal to sign an informed consent form or refusal to undergo follow-up; 2. stroke or cardiovascular and cerebrovascular events within 6 months before enrollment; 3. previous hematopoietic stem cell or bone marrow transplantation; 4. major surgical treatment, incisional biopsy or significant traumatic injury within 28 days before the start of study treatment; or long-term unhealed wounds or fractures; 5. History of live attenuated vaccination within 14 days before the start of study treatment or planned live attenuated vaccination during the study; 6. Participating or participating in other clinical investigators within 4 weeks before the start of the study; 7. Known hypersensitivity to active ingredients or excipients such as triamcinolone acetonide; 8.Other conditions that, in the opinion of the investigator, make participation in this study inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of severe neutropenia during the treatment cycle;The incidence of granulocytopenia accompanied by fever during the treatment cycle; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse reactions;Quality of life score;Cytokines such as IL-6 and IL-8;objective response rate;safety; | — |
Countries
China
Contacts
Public ContactHaichuan Su
Tangdu Hospital, Fourth Military Medical University
Outcome results
None listed