Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Conditions
Interventions
Combination Therapy of Sintilimab and Chemotherapy with Cryoablation:Cryoablation
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.A written informed consent must be signed before the implementation of any trial-related procedures. 2.Age >=18 years and 3 months. 12.Adequate organ function, with the following laboratory criteria: a) Absolute neutrophil count (ANC) =1.5x10^9/L without granulocyte colony-stimulating factor use in the past 14 days. b) Platelet count >=100×10^9/L without blood transfusion in the past 14 days. c) Hemoglobin >9g/dL without blood transfusion or erythropoietin use in the past 14 days. d) Total bilirubin <=1.5 times the upper limit of normal (ULN). e) Aspartate transaminase (AST) and alanine transaminase (ALT) <=2.5 times ULN (ALT or AST <=5×ULN allowed for patients with liver metastases). f) Serum creatinine <=1.5 times ULN and creatinine clearance (calculated by Cockcroft-Gault formula) =60 ml/min. g) Coagulation function within normal range, defined as international normalized ratio (INR) or prothrombin time (PT) <=1.5 times ULN. h) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within normal range. If baseline TSH is outside the normal range, patients with normal total T3 (or FT3) and FT4 may still be included. i) Normal cardiac enzymes (patients with isolated laboratory abnormalities judged by the investigator as clinically
Exclusion criteria
Exclusion criteria: 1.Pathologically confirmed small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC; 2.Received radiation therapy prior to the first administration of the study drug, meeting any of the following conditions: 1) Radiation therapy to =30% of the bone marrow within 14 days before treatment. 2) Radiation therapy to lung lesions with a dose >30 Gy within 6 weeks before treatment (participants must have recovered from the toxicity of previous radiation therapy to Grade 1 or lower, require no glucocorticoid treatment, and have no history of radiation pneumonitis). 3) Completion of palliative radiotherapy within 7 days before the first administration of the study drug. 3.Diagnosed with malignancies other than NSCLC within 5 years before the first dose of study drug (excluding cured basal cell carcinoma, squamous cell carcinoma of the skin, and/or in situ carcinoma); 4.Currently participating in an interventional clinical study or has received another investigational drug or used an investigational device within 4 weeks prior to the first dose. 5.Previously received therapy including anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs targeting another T cell receptor for stimulation or co-inhibition (e.g., CTLA-4, OX-40, CD137); 6.Received systemic treatment with traditional Chinese medicine with anti-NSCLC indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural effusion) within 2 weeks prior to the first dose. 7.Active autoimmune diseases requiring systemic treatment within 2 years before the first dose of study drug. Alternative therapy (e.g., thyroid hormone, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic treatment; 8.Receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation, or other topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study drug. Note: The use of physiological doses of glucocorticoids (<=10 mg/day of prednisone or an equivalent drug) is allowed. 9.Presence of clinically uncontrolled pleural effusion or ascites (participants who do not require drainage or show no significant increase in effusion after stopping drainage for 3 days may be enrolled). 10.Known history of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation. 11.Known allergy to the active ingredients or excipients of the study drugs, including sintilimab, pemetrexed, gemcitabine, carboplatin, cisplatin, or others. 12.Prior to the start of treatment, participants have not sufficiently recovered from any toxicities and/or complications caused by previous interventions (i.e., recovery to <= Grade 1 or to baseline, excluding fatigue or hair loss). 13.Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive). 14.Untreated active hepatitis B (defined as HBsAg positive with HBV-DNA copies greater than the upper limit of normal at the laboratory of the study center); Note: Participants with hepatitis B who meet the following criteria may also be enrolled: 1) HBV viral load < 1,000 copies/ml (200 IU/ml) before the first dose; these participants should receive anti-HBV therapy throughout the study's chemotherapy treatment to prevent viral reactivation. 2) Participants with anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess the objective response rate of subjects determined by investigators;Assess the disease control rate of subjects determined by investigators;Assess the duration of response of subjects determined by investigators;Overall survival of subjects.;Safety and tolerability of Sintilimab in combination with cryoablation and platinum-based doublet chemotherapy; | — |
Countries
China
Contacts
Public ContactZhong Hua
Shanghai Chest Hospital
Outcome results
None listed