Postoperative assistance for non-small cell lung cancer
Conditions
Interventions
Experimental group:sintilimab monotherapy was maintained for 1 year after operation
Control group:Postoperative observation
Sponsors
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent prior to the implementation of any trial-related procedures; 2. Male or female, aged 18-75 years; 3. Patients with stage IIIA-IIIB NSCLC confirmed by pathological examination; 4. Patients who have received neoadjuvant immunotherapy in the past and have achieved pCR after surgery; 5. ECOG score 0-1 points; 6. At least 1 measurable lesion according to RECIST1.1 criteria; 7. Adequate organ function, subjects need to meet the following laboratory indicators: 1) Absolute neutrophil value (ANC) >=1.2x10^9/L without the use of granulocyte colony-stimulating factor in the past 14 days; 2) Platelet >=75×10^9/L; 3) In the absence of blood transfusion or erythropoietin in the past 7 days, hemoglobin >=9g/dL; 4) total bilirubin =50 ml/min; 7) good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <=1.5 times ULN; 8) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within normal limits. If the baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; 9) Cardiac enzyme spectrum within the normal range (if the investigator comprehensively judges that it is not clinically significant, simple laboratory abnormalities are also allowed to enroll); 8. For female subjects of childbearing age, a urine or serum pregnancy test with a negative result should be received within 3 days prior to receiving the first dose of study drug (Cycle 1 Day 1). If a urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is requested. Females of non-childbearing potential are defined as at least 1 year postmenopausal, or have undergone surgical sterilization or hysterectomy; 9. If there is a risk of conception, all subjects (male or female) are required to use contraception with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last dose of study drug.
Exclusion criteria
Exclusion criteria: 1.Patients are currently participating in an interventional clinical study, or have received other investigational drugs or been treated with investigational devices in the 4 weeks prior to initial dosing; 2.Allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation is known; 3.Known allergy to the active ingredient or excipient of the drug sintilimab; 4.Have not fully recovered from toxicity and/or complications caused by any intervention before starting treatment (i.e., = grade 1 or baseline, excluding weakness or hair loss); 5.Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive); 6.Untreated active hepatitis B (defined as HBsAg positive with a detected HBV-DNA copy number greater than the upper limit of normal in the laboratory of the study center); 7.Active HCV-infected subjects (HCV antibody positive with HCV-RNA levels above the lower limit of detection); 8.Situations that other researchers believe do not meet the inclusion requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year recurrence-free survival (2-year DFS rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) assessed against RESIST v1.1;Assessment of Duration of response (DOR) in subjects according to RECIST V1.1;Assessment of disease control rate (DCR) in subjects according to RECIST V1.1;Relapse-free survival (DFS);overall survival;1-year overall survival (OS);Incidence of adverse events (AE), Serious Adverse Events (SAE), Immune-related Adverse Events (irAE); | — |
Countries
China
Contacts
Public ContactTu Zhengliang
The First Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed