limited-stage small cell lung cancer
Conditions
Interventions
Experimental group:neoadjuvant Sintilimab plus chemotherapy followed by surgery
Sponsors
Cancer Hospital of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Sign written informed consent before carrying out any trial-related procedures; 2.Age >=18 years and 3 months; 9.Adequate organ function, meeting the following lab criteria: (1)Absolute neutrophil count (ANC) >=1.5×10^9/L without the use of G-CSF in the past 14 days; (2)Platelets >=100×10^9/L without transfusion in the past 14 days; (3)Hemoglobin >9 g/dL without transfusion or erythropoietin use in the past 14 days; (4)Total bilirubin =60 ml/min; (7)Good coagulation function, defined as INR or PT <=1.5×ULN; (8)Normal thyroid function, defined as TSH within the normal range. If baseline TSH is out of range, enrollment is allowed if total T3 (or FT3) and FT4 are normal; (9)Normal myocardial enzyme profile (mild lab abnormalities considered clinically insignificant may be allowed per investigator judgment); 10.Female participants of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to the first dose of the study drug (Cycle 1, Day 1). If urine test results are inconclusive, a blood test is required. Women not of childbearing potential are defined as postmenopausal for at least 1 year or surgically sterilized or hysterectomized; 11.For those at risk of pregnancy, all participants (male and female) must use a contraceptive method with a failure rate of less than 1% throughout treatment and for 120 days (or 180 days) after the last dose of the study drug.
Exclusion criteria
Exclusion criteria: 1.Mixed SCLC and NSCLC confirmed by histology or cytology; 2.Diagnosis of any malignancy other than SCLC within 5 years before the first dose (excluding fully treated basal cell carcinoma, squamous cell carcinoma of the skin, and/or completely resected carcinoma in situ); 3.Currently participating in interventional clinical research treatment, or having received other investigational drugs or investigational device treatments within 4 weeks before the first dose; 4.Any prior systemic anti-tumor therapy or immune checkpoint inhibitor treatment for SCLC: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs targeting other stimulatory or co-inhibitory T-cell receptors (e.g., CTLA-4, OX-40, CD137), etc.; 5.Receiving systemic treatment with Chinese medicine or drugs with immunomodulatory effects (including thymosin, interferons, interleukins, excluding local use for controlling pleural effusion) within 2 weeks before the first dose; 6.Active autoimmune disease within 2 years before the first dose that required systemic treatment (such as disease-modifying drugs, glucocorticoids, or immunosuppressants). Replacement therapy (like thyroid hormone, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) is not considered systemic treatment; 7.Receiving systemic glucocorticoid therapy (excluding nasal, inhaled, or other local routes) or any other form of immunosuppressive therapy within 7 days before the first dose; note: physiological doses of glucocorticoids (<=10 mg/day of prednisone or equivalent) are allowed; 8.Clinically uncontrolled pleural or peritoneal effusion (subjects who do not need drainage or whose effusion does not significantly increase within 3 days after stopping drainage can be included); 9.Known allogeneic organ transplant (excluding corneal transplant) or allogeneic hematopoietic stem cell transplant; 10.Known allergy to the active ingredients or excipients of the study drugs, including Sindilimab, Etoposide, Carboplatin, etc.; 11.Not fully recovered from any toxicities and/or complications caused by prior interventions before starting treatment (i.e., <= Grade 1 or returned to baseline, excluding fatigue or hair loss); 12.Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 13.Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copies above the normal upper limit of the testing center); Note: Subjects with hepatitis B meeting the following criteria may also be included: (1)HBV viral load <1000 copies/ml (200 IU/ml) before first dose, subjects should receive anti-HBV therapy throughout the study treatment to avoid viral reactivation; (2)Subjects who are anti-HBc positive, HBsAg negative, anti-HBs negative, and HBV viral load negative do not need preventive anti-HBV treatment but should be closely monitored for viral reactivation; 14.Subjects with active HCV infection (HCV antibody positive and HCV-RNA above the detection limit); 15.Received a live vaccine within 30 days before the first dose (Cycle 1, Day 1); Note: Receiving an injectable inactivated seasonal flu vaccine within 30 days before the first dose is allowed; however, intranasal live attenuated flu vaccines are not allowed; 16.Pregnant or breastfeeding women; 17.Presence of any severe or uncontrolled systemic diseases, such as: (1)Significant and symptomatically unmanageable abnormalities on resting ECG in terms of rhythm, conduction, or morphology, such as complete left bundle br
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival (EFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR);Major pathological response (MPR) rate;Overall survival (OS);Adverse events (AES);Pathological complete response (pCR) rate; | — |
Countries
China
Contacts
Public ContactWei Huang
Cancer Hospital of Shandong First Medical University
Outcome results
None listed