Small Cell Lung Cancer
Conditions
Interventions
Test group:Toripalimab(240mg D1,Q3W ) + topotecan capsules(Oral, 1 to 5 days of continuous administration, two pills a day, with dinner, then stop the drug for 16 days, every 3 weeks
Sponsors
Shandong First Medical University Affiliated Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age =18 years and =75 years; 2) ECOG score =1 3) Histologically or cytologically confirmed limited stage small cell lung cancer (stage I-III); 4) Patients who show no progression within 30 days after undergoing standard concurrent or sequential chemo-radiotherapy. 5) At least one measurable lesion according to RECIST v 1.1 6) Life expectancy is at least 12 weeks 7) No contraindications to chemotherapy or immunotherapy; 8) Before the first dose of drugs for study, patients should have appropriate organ function and the laboratory results must meet conditions as following: Hematology: white blood cells =3.0×109/L, neutrophil absolute value (ANC) =2.0×109/L, hemoglobin =90g/L,platelet count =100×109/L,Serum albumin = 2.8 g/dL. Liver function: total bilirubin is lower than 1.5 times the maximum normal value; ALT and AST are lower than 3 times the maximum normal value. Serum creatinine = 1.5xULN or creatinine clearance > 60 mL/min. 9) Female subjects of childbearing potential, as well as male subjects with partners of childbearing potential, need to use a medically recognized contraceptive (such as uterine energy, internal contraceptive devices, contraceptives, or condoms) during study treatment, and at least 3 months after the last use of toripalimab and at least 6 months after the last use of chemotherapy or radiotherapy; 10) Subjects voluntarily join this study, and signed informed consent, with good compliance, can cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1) Extensive small cell lung cancer; 2) Other concurrent uncontrolled malignancy. 3) Patients with severe heart disease, pulmonary dysfunction, cardiac function and pulmonary function lower than grade 3 (including grade 3); 4) Laboratory test values within 7 days before enrollment that do not meet the relevant criteria; 5) Systemic or local glucocorticoid therapy within 4 weeks prior to enrollment; 6) Patients with comorbidities requiring chronic immunosuppressive drug therapy or systemic or local corticosteroids at immunosuppressive doses; 7) Active infection requiring systemic therapy; 8) Patients with active pulmonary tuberculosis (TB) who are receiving anti-TB treatment or who have received anti-TB treatment within 1 year prior to screening; 9) HIV positive; 10) HBsAg positive and HBV DNA copy number positive (quantitative detection = 1000cps/ml or IU/ml); chronic hepatitis C blood screening positive (HCV antibody positive); 11) Women of childbearing potential with positive pregnancy test and lactating women. 12) History or evidence of disease, treatment, or abnormal laboratory values that could interfere with the results of the trial, prevent the subject from fully participating in the study, or other conditions that, in the opinion of the investigator, would make enrollment inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Duration of Response ; | — |
Countries
China
Contacts
Public ContactHaiyong Wang
Shandong First Medical University Affiliated Cancer Hospital
Outcome results
None listed