limited-stage SCLC
Conditions
Interventions
Experimental group:Phase I: Adbelizumab + etoposide + cisplatin or carboplatin (3-week regimen, 2 treatment cycles)
Stage II: Imaging efficacy assessment was performed after treatment in stage I, and patients were entered into two cohorts to receive radiotherapy according to their baseline and efficacy assessment (
2. Axial lesions overlapped with esophagus < 1/3 esophageal cross section
3. Overlap length of longitudinal lesions and esophagus < 3cm
4. Double lungs 17%
The radiotherapy dose of cohort A was individually determined by the investigator according to the degree of tumor regression after stage I, specifically, after stage I treatment, target lesion shrink
Stage III: Start drug therapy within 2 weeks after the end of radiation therapy, and the treatment plan is referred to stage I, 2-4 cycles
Phase IV: Adbelizumab monotherapy maintenance, 3-week regimen, maintenance until PD or intolerable toxicity, adbelizumab treatment for a maximum of 1 year (calculated from the date of first adbelizuma
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily joined the study, signed the infom consent form (ICF), had good compliance, and cooperated with follow-up; 2. Age 18-75 years old, male or female; 3. ECOG physical strength score 0-1; 4. Histologically/cytologically confirmed limited-stage small cell lung cancer (according to AJCC 8th Edition); 5. There is at least one measurable lesion defined by the RECIST standard v1.1; 6. Can provide tumor tissue specimens; 7. Have full organ function, that is, meet the following criteria (no blood transfusion and blood products within 14 days, no correction with G-CSF and other hematopoietic stimulating factors) : Blood routine: hemoglobin (HGB) =90g/L; Platelet (PLT) =100×109/L; Neutrophil count (ANC) =1.5×109/L; White blood cell count (WBC) =3.0×109/L; Blood biochemistry: ALT, AST, alkaline phosphatase (ALP) = 2.5×ULN; Serum total bilirubin (TBIL) =1.5×ULN (Gilbert syndrome 1.5×ULN without clinical or imaging evidence of pancreatitis could be included in the study. Doppler ultrasound assessment: left ventricular ejection fraction (LVEF)=50%; 8. Women of childbearing age must have a serum pregnancy study, and the result is negative. Female subjects of reproductive age and male subjects whose partners are women of reproductive age must agree to use at least one medically approved contraceptive method during the study treatment period and for 3 months after the end of the study treatment period;
Exclusion criteria
Exclusion criteria: 1. Histological or cytopathological diagnosis of mixed SCLC or NSCLC; 2. Previously received systemic anti-tumor therapy for SCLC or anti-tumor therapy with immune checkpoint inhibitors; 3. Extensive SCLC; 4. Operable SCLC; 5. Malignant pleural effusion; 6. Subjects with known or suspected interstitial pneumonia; Other moderate to severe lung diseases that may interfere with the detection or management of drug-related pulmonary toxicity and seriously affect respiratory function; 7. Active, known or suspected autoimmune disease and history of autoimmune disease; 8. Concurrent with other malignant tumors =5 years before the first dose; 9. Patients with a clinically significant history of cardiovascular disease; 10. The first study of arteriovenous thrombosis events occurring within 6 months before medication; 11. Severe infection within 4 weeks before the first dose; 12. Patients with active pulmonary tuberculosis infection within 1 year prior to enrollment were found through medical history or CT examination, or had a history of active pulmonary tuberculosis infection more than 1 year ago without formal treatment; 13. History of immune deficiency; 14. Patients with active hepatitis B or C; 15. Received systemic immunosuppressive therapy within 14 days before the first study; 16. Has undergone major surgery (other than surgery for diagnostic purposes) within 28 days before the first dose, or expects to undergo major surgery (other than surgery for diagnostic purposes) during the study period; Received diagnostic or low-trauma surgery within 7 days prior to initial medication; 17. Use of live attenuated influenza vaccine within 28 days prior to the first administration, or anticipated use of live attenuated influenza vaccine during the study period (patients are not allowed to receive live attenuated influenza vaccine within 28 days prior to the first administration, during treatment, and within 5 months after the last administration of SHR-1316/ placebo); 18. Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation; 19. Known history of severe allergic reactions to monoclonal antibodies/fusion protein drugs; 20. Known mental illness, alcohol, drug or substance abuse; 21. According to the investigator's judgment, the subjects have other factors that may lead to the forced termination of the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-month overall survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free Survival; Local Progression-free Survival;Adverse Event; | — |
Countries
China
Contacts
Public ContactGuohao Xia
Jiangsu Cancer Hospital
Outcome results
None listed